Meeting Guide

Transcription

Meeting Guide

The Parenteral Drug Association presents:
2016
1 PDA Europe
st
Annual Meeting
T H E F U T U R E I N I N J EC TA B L E S
MEETING GUIDE
Roundtables | Conference | Exhibition | Education Program
27 June - 1 July 2016
Estrel Hotel Berlin
Berlin | Germany
#pdaeuannual
Platinum Sponsor
Gold Sponsor
Silver Sponsor
Media Partner
WELCOME FROM THE CHAIR
Dear Friends, Colleagues, Collaborators and Peers,
Welcome to Berlin and PDA Europe’s first Annual Meeting The Future in Injectables!
This meeting was carefully developed to provide you with a first-hand opportunity to stay current and anticipate future
advances in modern sterile manufacturing and quality oversight. The Scientific Program Planning Committee has worked hard
to offer you a very unique program with new and exciting topics specifically aimed at reflecting innovative approaches and
cutting edge technologies.
Renowned industry leaders and international regulators will share their experience with you in daily plenary sessions and a
series of parallel tracks. The opening plenary session will focus on strategies developed by partakers in healthcare to strive in
the context of globalization and rapid scientific innovation. Concurrent sessions are designed to address many of the current
challenges our industry and regulators faces. They will feature over thirty presentations with practical examples and case studies,
and offer the perfect blend of industry updates, educational topics, technical advances and trends in regulatory oversight. We
will dive deeply into continuous manufacturing, flexible facilities, modern analytical technologies, automation and robotics,
blow-fill-seal technology, big data processing and ‘industry 4.0’, serialization and product tracking implementation, data
integrity, innovative injection devices, and – last but not least – the related regulatory aspects. The conference will conclude
with an outlook to the future of our industry, covering facilities, manufacturing and therapies of the future in a global context.
Opportunities to interact with speakers, industry peers, regulators, exhibitors and PDA leadership will be plenty. They include
extended networking breaks, interactive roundtable discussions with PDA chapters from Europe and Japan and a very special
European networking reception on the evening of June 28th.
As an extended offer, on June 30th and July 1st PDA Europe will be hosting several in-depth training courses that are designed
to complement topics presented at the conference.
PDA Europe’s first Annual Meeting The Future of Injectables shows once again PDA’s commitment to bringing manufacturing
technology advances to the forefront and facilitating discussions between industry, suppliers and regulators. You will leave the
conference richer, both in terms of knowledge and relationships, which will benefit your career and organization.
On behalf of the program planning committee and PDA staff, wish us all a week filled with fruitful discussion and continuous
learning through professional interaction and exchange of ideas!
Welcome to Berlin!
Ursula Busse, PhD MBA, Novartis Group Quality
Conference Chairwoman
2
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Table of Contents
Activities at a Glance
4
Roundtable Discussions
6
Conference
8
Networking Event
11
Poster Session
15
Floor Plan
17
Exhibitor Abstracts
18
PDA Education Program
25
Test Methods for Pre-filled Systems
26
Cleaning and Disinfection
28
How to Find the Right GMP for APIs
30
Root Cause Investigation for CAPA
32
Development and Manufacturing
of Pre-filled Syringes
34
Information
PDA Social Media Guide
38
39
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3
ACTIVITIES AT A GLANCE
Monday, 27 June
8:00 - 17:00
Exhibition Set-up
13:30 - 15:30
16:00 - 18:00
Room 30241
Room 30241
Roundtable Discussion
Business Opportunities India
8:00 - 18:00
Registration Hours
Business Opportunities Iran
17:00 - 18:00
18:00 - 20:00
Room Paris
Biergarten - Terrace by the river Spree
Chapter Council Meeting
(by invitation only)
Welcome Reception
“Willkommen” to Berlin
Tuesday, 28 June
8:00 - 18:00
9:00 - 18:30
Registration Hours
Conference Day 1
3 Tracks A, B, C
Rooms A, B, C
14:00 - 16:00
19:00 - 22:30
EU Exhibition Committee Meeting
PDA Europe Networking Event
"Summer in Berlin"
Pier 13 Restaurant & Bar, Tempelhofer Damm 227, 12099 Berlin
Room 30241
Meeting Point for Bus Shuttle: Hotel Estrel - PDA Registration Desk
Wednesday, 29 June
8:00 - 17:00
9:00 - 17:30
Registration Hours
Conference Day 2
3 Tracks A, B, C
Rooms A, B, C
7:00 - 8:00
8:00 - 9:00
8:00 - 9:00
8:00 - 9:00
Room Paris
Room A
Room B
Room C
Orientation Breakfast
Morning Roundtables
PDA Chapters Italy, France, UK
Morning Roundtables
PDA Chapters Ireland, Israel, Japan
Interest Group Meeting
TechTransfer
Thursday, 30 June
7:30 - 12:00
9:00 - 17:00
Registration Hours
Education & Training
Test Methods for Pre-filled Syringe Systems
One-Day Training Course
Room Lyon
9:00 - 17:30
9:00 - 18:00
9:00 - 17:45
Room 30212
Room 30241
Room Paris
How to Find the Right GMP
for APIs
Root Cause Investigation
Training Course, Day 1
9:00 - 18:00
Room 30210
Workshop, Day 1
Friday, 1 July
8:00 - 12:00
Registration Hours
Education & Training
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9:00 - 16:30
8:30 - 16:45
Training Course, Day 2
Workshop, Day 2
Room 30241
Room Paris
13:00 - 14:00
Open House
PDA Europe Office Visit
Am Borsigturm 60
13507 Berlin
SCIENTIFIC PROGRAM PL ANNING COMMITTEE
1
2
3
4
1 Ursula Busse, Conference Chair, Novartis
2 Jette Christensen, Novo Nordisk
3 Véronique Davoust, Pfizer
5
6
7
8
4 Derek Duncan, LIGHTHOUSE
5 Gabriele Gori, GSK Vaccines
6 Eric Meier, Novartis
7 Stephan Rönninger, Amgen
9
10
11
12
8 Mihaela Simianu, Consultant
9 Ryan Smith, SightMachine
10 Jochen Strube, Clausthal University of Technology
11 Sylvia Becker, PDA Europe
12 Georg Roessling, PDA Europe
Your end-to-end partner
for Industrial Performance
and Compliance in
LIFE SCIENCES
Competences
 Quality & Regulatory Compliance
 Process Engineering
 Smart Manufacturing
 Life Science Digitalisation
 Innovative Medical Solution Development
altran.de
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ROUNDTABLE DISCUSSIONS
Monday, 27 June
Moderator: Georg Roessling, PDA Europe
Room
30341
13:30
Indo-German Economic Relations: Missed Opportunities
Sushil Khanna, University Calcutta, Visiting Professor in Leipzig
Joerg Strassburger, Go East, Advisors for Emerging Markets
Yvonne Metzger,
Bundesverband mittelständische
Wirtschaft - The German Association for
Small and Medium-sized Businesses
Q&A, Discussion with Exhibitors and Conference Participants
15:30
End of Business Opportunities India
Moderator: Georg Roessling, PDA Europe
Room
30341
16:00
Please join the roundtable discussion on the current situation of the
pharmaceutical industry in Iran. Topics of discussion will be:
•
Regulatory Environment of the Iranian Pharmaceutical Industry
•
Modernisation Needs of the Pharmaceutical Industry
Akbar Abdollahiasl, General Director of Pharmaceutical Affairs, Ministry of Health, Iranian FDA
Zohre Bazaz, Inspector, Iranian FDA
Q&A, Discussion with Exhibitors and Conference Participants
18:00
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End of Business Opportunities Iran
ROUNDTABLE DISCUSSIONS
Speaker Biographies
Yvonne Julia Metzger, CEO, markets and more
Yvonne Julia Metzger, M.A., is founder and CEO of markets and more, General Manager BVMW India and official representative of BVMW
e.V. (Bundesverband für mittelständische Wirtschaft) in the metropolitan region Hamburg. As CEO of markets and more, she works for
several companies as Sales Manager, CRM and Marketing Manager, speaker and trainer. markets and more is specialized in developing
and implementing marketing strategies and finding sales partners for companies in Germany, Europe and India with focus on biotech,
medical and pharma industry. Yvonne Julia Metzger has more than ten years of international experience in marketing, sales and event
management. She has built up and guided the department for sales and marketing at one of the leading laser fiber manufacturers in Germany. Prior to that,
she worked as project manager at the German-Dutch Chamber of Commerce in The Hague and in a market research company.
Joerg Strassburger, CEO, Go East Advisors
Dr. Joerg Strassburger is the Founder and CEO of Go East Advisors. With offices in Germany and India, the company is supporting European chemical companies in their business development in Asia with a strong focus on the Indian market. Besides strategy development
and strategy implementation to achieve stronger business growth in India, he and his partner identified India as an attractive sourcing
market for chemical intermediates. Purchasing services range from spot purchasing of mineral fillers to the establishment of contract
manufacturing agreements for pharmaceutical intermediates. Go East Advisors’ business portfolio also includes identifying the right
partners to establish long-term partnerships, JV’s or Acquisitions between Indian and European chemical companies. Before founding Go East Advisors, Dr.
Strassburger was the Country Representative and Managing Director of LANXESS India Private Limited from 2005 to 2014. He was responsible for the operations and development of LANXESS' business units in India. Before this assignment, Dr. Strassburger was head of Corporate Development at LANXESS AG,
and was actively involved in developing LANXESS' global strategy.
Akbar Abdollahiasl, General Director of Pharmaceutical Affairs, Ministry of Health, Iran
Dr. Abdollahiasl is General Director of Pharmaceutical Affairs in Iran's Ministry of Health and assistant professor in Tehran University of
Medical Sciences. He is a pharmacist and PhD of Pharmacoeconomics and Pharmaceutical Administration. While working in the pharmaceutical fields, he’s had the responsibility of management of medicinal supply chain, medical and pharmaceutical data analysis,
pricing of pharmaceutical products and planning of NRA systems as well as the Head of Statistic and Planning Office in Iran Food & Drug
administration. He has directed more than 20 research projects trying to find a system dynamics model for national drug policy and on
subjects such as Iran medicine’s prices, availability, affordability and price components (in corporation with HAI), essential medicines and pharmaceutical
policies unit, pharmaceutical education in Iran and cost of different illnesses in Iran. He’s participated in some courses like Health Sector Reform course
offered by American University of Beirut (2003-2004), Pricing and Reimbursement course offered by Vienna School of Clinical Researches (2005) and some
MIS and data mining courses. He is one of the key opinion leaders of pharmaceutical fields in Iran.
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CONFERENCE AGENDA
The Future in Injectables
Digital Version
Tuesday, 28 June
9:00
Welcome: Opening Remarks, Introduction & PDA Awards Georg Roessling, PDA Europe
Ursula Busse, Novartis, Conference Chair
Moderator: Ursula Busse,
Novartis
Opening Plenary
9:15
The Quality Journey: From Good to Great
Martin van Trieste, Amgen
9:45
A Question of Trust – Hard Won, Easily Lost
John Johnson, NSF Health Sciences
10:15
Overcoming the Divide of Excellence & Quality
Thomas Friedli, University of St. Gallen
10:45
Coffee Break, Poster Session & Exhibition
11:15
Regulatory Considerations for Continuous Manufacturing:
EU Perspective
Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party
11:45
The International Role of PIC and PIC/S in Harmonizing Inspections
Paul Hargreaves, MHRA, PIC/S
12:15
Q&A, Discussion
12:45
Lunch Break, Poster Session & Exhibition
13:40
Transition to Parallel Tracks
PARALLEL TRACKS
Rooms
Session 1
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A
B
C
TRACK A
TRACK B
TRACK C
Continuous Manufacturing
& Flexible Facilities
Testing
Lifecycle Management
and Innovation:
Are they Mutually Exclusive?
CONFERENCE AGENDA
Moderators: Mihaela Simianu, Consultant
Session 1
13:45
Jette Christensen, Novo Nordisk
& Flexible Facilities
Testing
Ursula Busse, Novartis
Lifecycle Management
and Innovation:
Are they Mutually Exclusive?
Concepts and Solutions for
Attribute Focus to Achieve the
Quality Target Product Profile
(QTPP)
Challenges of Pharma Industry with
Lifecycle Approach
Eric Meier, Novartis
Rohini Deshpande, Amgen
Anders Vinther, Sanofi Pasteur
Process Development and
Engineering Challenges for Future
Manufacturing of Biologics
Post Approval Lifecycle Management of Analytical Control Systems
From QbD to Lifecycle Management:
Regulatory Perspective of Guidelines that should Encourage
Innovation - Opportunities and
Challenges
Jochen Strube, Clausthal University
Emma Ramnarine, Genentech / Roche
Jean-Louis Robert,
European Medicines Agency,
Chair of the CHMP/CVMP
Quality Working Party
Traceability in Continuous
Manufacturing
All-in-One Solution for
Parenteral Containers CCI Testing
and Headspace Gas Verification
Recent Initiatives put Forward by
the WHO to Facilitate Post-Approval
Change Management for Vaccines
Jochen Thies, Glatt Group
Andrea Simonetti, Bonfiglioli Engineering
DianLiang Lei, World Health Organization
15:15
Q&A, Discussion
Q&A, Discussion
Q&A, Discussion
15:45
14:15
14:45
PARALLEL TRACKS
Rooms
Session 2
A
B
C
TRACK A
TRACK B
TRACK C
Automation & Robotics
Testing
Blow-Fill-Seal
Moderators: Masahiro Akimoto, Otsuka Pharm. Factory Jette Christensen, Novo Nordisk
Stephan Rönninger, Amgen
Georg Roessling, PDA Europe
16:15
Nanoparticle Technology in
Pharmaceutical Applications
Testing of Final Product during
Scale Up: Lessons Learned
Pre-filled Syringes made by
Blow-Fill-Seal
Sanshiro Nagare, Nara Machinery
Derek Duncan, LIGHTHOUSE
Rajeev Kabbur, Brevetti Angela
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CONFERENCE AGENDA
Session 2
Testing
Blow-Fill-Seal
Moderators: Masahiro Akimoto, Otsuka Pharm. Factory Jette Christensen, Novo Nordisk
Georg Roessling, PDA Europe
16:45
17:15
17:45
10
Automation & Robotics
A New Generation Packaging Line
for Filled Product in Carton with
Integrated Dividers
CCIT Technology on BFS Containers:
From the High Speed Testing
Prospective, the Testing Reliability
and the Validation Approach
Basic Principles and Regulatory
Requirements for BFS Technology
including Qualifications and
Validation Aspects
Hiroaki Mizuno, Omori Machinery
Jaime Cobo, Wilco
Christoph Bohn, Holopack Packaging Technology
Overview of the Low Voltage
Electron Beam Sterilization System
and its Benefits
In-Line Automated Visual Particle
Inspection of BFS Containers for
Injectable Drug Products
Specific Aspects for Manufacturing
and Autoclaving of BFS Products
Koji Kawasaki, AirEX
Heino Prinz, rommelag
Martin Haerer, Holopack Packaging Technology
Moderator:
Masahiro Akimoto, Otsuka Pharm. Factory
Moderator:
Gabriele Gori, GSK Vaccines
Experience with Filling of
Biological Products with Cool
BFS Technology
Business Opportunities Japan
Final Product Control:
CCIT & Visual Inspection–
Do we need it?
What will Annex 1 bring?
Session Speakers
Session Speakers
18:30
End of Day 1
19:00
Joint Departure & Networking Event @ Pier13
#pdaeuannual
Otto Schubert, Maropack
HE
AR
TH
T: D P
AC A N
L
IA A B
EC P D
SP S T
R
FI
E
Shuttle Bus leaving at 19:00h
Shuttle Bus returning to the Estrel Hotel 22:30h
Dress Code: Casual Summer Look
Please confirm your attendance at the PDA Registration Desk. If you have any dietary requirements, please let us know.
Pier 13 | Tempelhofer Damm 227 | Tempelhofer Hafen | 12099 Berlin
.
Meeting Point: Hotel Estrel - PDA Registration Desk
NG
Networking Event
YI
LA
Summer in Berlin
The Parenteral Drug Association presents:
CONFERENCE AGENDA
Wednesday, 29 June
7:30
Welcome Coffee
MORNING ROUND TABLES
8:00
MEET THE PDA CHAPTERS
PDA has 24 Chapters around the world with local programs and resources to help you stay informed, interact with
your peers, and facilitate exchange with the pharmaceutical and biopharmaceutical industry. Meet six of these
chapters in this morning session and get to know the chapter presidents and industry peers in your region!
ROOM A
ITALY / SWITZERLAND
FRANCE
ROOM B
UK
IRELAND
ISRAEL
JAPAN
INTEREST GROUP MEETING, TECH TRANSFER (TT IG)
8:00
Room C
•
•
•
Scope and Activities
Technical Report #65
TT IG current picture
- Membership, Geographic distribution, Expertise onboard
•
•
Goals for 2016 & Next steps
Q&A, Discussion
IG Leader:
Mirko Gabriele, Patheon
PARALLEL TRACKS
Rooms
Session 3
B
C
TRACK A
TRACK B
TRACK C
Big Data Processing / Industry 4.0
Regulatory Track
Technical Track
Moderators: Georg Roessling, PDA Europe
Jette Christensen, Novo Nordisk
Mihaela Simianu, Consultant
9:10
Industry 4.0 - Readiness for
Pharmaceutical Companies
What an Inspector Needs to Know
About Assessment
Serialization Requirements
in Europe
Andreas Traube,
IPA Fraunhofer Institute
Kevin O’Donnell, Health Products Regulatory Authority,
Ireland (HPRA)
Véronique Davoust, Pfizer
Industry 4.0: How to Identify and
Use Key Enabling Technologies –
Demonstration by Case Studies
Challenges in Pharmaceutical
Industry-SME Perspective
Serialization and Product Tracking
Implementation in a
Global Environment
Francisco Jose Herrador Jorro, Altran
Andreas Sachse, CPL SACHSE
Michael Ritter, Novartis
9:40
12
A
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CONFERENCE AGENDA
Session 3
10:10
Big Data Processing / Industry 4.0
Regulatory Track
Technical Track
Manufacturing & Big Data:
Approaches for Pharma
Import of Pharmaceutical Products: Track and Trace
Annex 21, OECD Guideline
Implementation in Iran
Toni Manzano & Pep Gubau, BigFinite
Akbar Abdollahiasl, IFDA
10:40
Q&A, Discussion
Q&A, Discussion
Q&A, Discussion
10:55
11:25
Transition to Parallel Tracks
PARALLEL TRACKS
A
B
C
TRACK A
TRACK B
TRACK C
Modern Analytical Techniques
Data Integrity
Drug Administration
Rooms
Session 4
Moderators: Derek Duncan, LIGHTHOUSE
Eric Meier, Novartis
11:30
Predictive Modelling and Real-time
Analytics Applied to Fill and Finish
Operations
DI – A Criminal Act? Overview,
Clarification, Definition
Innovative Drug Delivery
Cenk Undey, Amgen
Anil Sawant, Merck & Co.
Ian Thompson, Ypsomed Delivery Systems
Digital Transformation for Biotechnology: A Big Data Approach to
Manufacturing Analytics
Data Integrity for Computer
Systems – A Bumpy Road to
Compliance
Smart Medication–Where
Electronics meet Drug Delivery
Ryan Smith, SightMachine
Wolfgang Schumacher, Roche
Markus Bauss, SHL Connect
Automated Media Fill Inspection
Data Integrity – A Holistic Approach
Best Practice in Glass Handling
During Device Development and
Commercialization
David Brueckner, Roche
Madlene Dole, Novartis
Thomas Schoenknecht, SHL Medical
13:00
Q&A, Discussion
Q&A, Discussion
Q&A, Discussion
13:15
Lunch Break, Poster Session & Exhibition
12:00
12:30
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CONFERENCE AGENDA
Session 5 : Closing Plenary - Future Developments
Moderator: Ursula Busse, Novartis
14:15
Past & Future of Injectable Dosage Forms for Biologics –
Quo vadis, Parenteralia?
Hanns-Christian Mahler, LONZA
14:45
Needs and Possibilities of New Manufacturing and Facility Design
Maik Jornitz, G-Con Manufacturing
15:15
Requirements and Opportunities for the
“Parenteral Facility of the Future”
Morten Munk, NNE Pharmaplan
15:45
16:15
Challenges for Medical Treatment in Future
16:45
Panel Discussion: The Future of Injectables
Samvel Azatyan, World Health Organization
In this panel discussion, we want to focus on the future of manufacturing, application of injectables and
regulatory aspects.
Some of the questions to be discussed are:
•
How innovative is the pharmaceutical industry?
•
What are hurdles for innovation and what can contributions from technology and regulatory bodies be?
•
How will new application concepts help patients?
•
Will the future see one global dossier and one harmonized inspection system?
•
What can ICH, WHO and PIC / S contribute?
Participants:
Samvel Azatyan, World Health Organization
Paul Hargreaves, MHRA and Chair of PIC / S
Steven Lynn, Novartis (and former FDA)
Hanns-Christian Mahler, Lonza
Martin van Trieste, Amgen
17:30
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Closing Remarks, End of Conference & Farewell Coffee
POSTER SESSION
During all coffee and lunch breaks, you have the opportunity to visit
the Poster Session located in the Exhibition Area.
Poster presenters will be happy to welcome you and answer your questions.
BiopuremaxPre-Treatment
Water System
Data Integrity Challenge:
The Infrastructure
Technology Lifebelt
A Scientific Approach to
Maintaining your
Stainless Steel Surfaces
Shlomo Sackstein,
Biopuremax
Danilo Maruccia, PQE
Paul Lopolito,
STERIS Corporation
Cleaning Validation Concerns
for Continuous
Manufacturing
Enzymatic dissolution
method for poorly soluble
Component Selection
Strategies for PFS:
Ball Milling Preparation
of Sustained Release
Suspension for
Intramuscular
Administration
Elizabeth Rivera,
STERIS Corporation
API in injectables depot
administration
Risk Mitigation, Performance
and Larger Injection Volume
Driving Innovative Solutions
Róbert Lehocky,
University of Chemistry and
Technology, Prague
Christa Jansen-Otten,
West Pharmaceutical Services
Daniel Pěček, Zentiva
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Global
Pharmaceutical
Solutions
Sensitive biopharmaceuticals?
We take the challenge
• Drug delivery solutions & technologies
for injection and infusion
• Expert platforms in pharmaceuticals,
polymers, coatings, precision and
miniaturization technologies
• Uncompromised Quality and Regulatory
Affairs support
• Committed to improved drug delivery
and patient comfort
16
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www.terumo-gps.com
1
PDA Lounge
2
5
C1
6
4
3
28 31
29 32
7
27
26
25
PDA
Registration
Exhibitor Lounge Entrance
Nara Machinery
1
Saint-Gobain
2
Veltek Associates
3
Groninger
4
Steris
5
PDA Registration
Toxikon
6
Buffet / Coffee Station
Iwata Label
7
Exhibition Stand
Novatek
8
C: Chapter Stand
Azbil Telstar
9
LIGHTHOUSE Instruments
11
Gateway Analytical
12
rap.ID
13
Altran
14
Bonfiglioli Engineering
17
Merck
19
Afton Scientific
20
NSF Pharma Biotech
21
Terumo
22
Wilco
23
PTI Inspection Systems
25
PQE
26
Watson-Marlow
27
OMORI Machinery
28
21
OMPI
29
biopuremax
31
20
Malvern Instruments
32
rommelag
37
Silver Sponsor
9
Poster Session
C2
C3
10
23
22
37
14
B
C4
A
13
PDA Country Chapter 17
C6
19
C
Poster
Session
Booth
10
Platinum Sponsor
Gold Sponsor
12
ESTREL HOTEL BERLIN
8
11
FLOOR PLAN
C5
Booth
Italy Chapter
C1
France Chapter
C5
United Kingdom Chapter
C3
Ireland Chapter
C4
Israel Chapter
C2
Japan Chapter
C6
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EXHIBITOR ABSTRACTS
Afton Scientific
2020 Avon Court
Charlottesville 22902, VA
United States
Tel: +1 434 97 93 73 7
Fax: +1 434 97 93 73 8
info@aftonscientific.com
www.aftonscientific.com
Afton Scientific
cGMP Processing of Sterile Products
Afton is a cGMP sterile processor of pre-packaged empty sterile vials,
stoppers and seals (Ready-to-Fill) to companies worldwide for immediate use in cGMP aseptic filling operations. These components
are used not only for small clinical fills, but also for approved marketed injectable drugs. Afton is inspected by both the US FDA and
MHRA. Aftonís customers include small biotechs, multinational pharmaceutical companies and major research institutions. Afton ships
worldwide. Afton also provides cGMP contract sterile filling services
of investigative new drugs, biologics and commercial injectable
pharmaceuticals.
Altran Deutschland
S.A.S. & Co. KG
Frankfurter Ring 81
80807 - Munich
Germany
P: +49 89 930 800
F: +49 89 930 139
ML-DE-info@altran.com
www.altran.com
With a network of 2,000 dedicated consultants in more than 15
countries, Altran delivers the highest level of expertise to over 200
customers to develop innovative medical solutions, improve their
operational performance and compliance and accelerate their digital transformation. Ageing population, chronic/lifestyle diseases,
emerging market expansion, treatment and technology advances,
together with important efforts to optimize healthcare spending,
outcomes and delivery are megatrends influencing companies operating in the Life Sciences industry. With over 30 years of experience
in Life Sciences, Altran provides adapted strategic, operational and
technological innovative services and solutions to support companies in all stages of the medical-product life cycle and help them
address cost and regulatory pressures, growing needs for modern
technologies integration across the whole value chain and a shift to
outcome-based business models.
Azbil Telstar United Kingdom
Unit 4, Shaw Cross Business Park
Horace Waller VC Parade
Dewsbury
West Yorkshire WF12 7RF
United Kingdom
T: 44 1924 455339 0
www.telstar.eu
Engineering, construction, consulting and validation services and
design, manufacture and sales of integrated process equipment
solutions with in-house sterilization, freeze-drying, containment,
barrier systems, production of PW, WFI, clean steam, clean air technologies and automated systems for Life and Health Sciences; integrating knowledge and technologies to provide optimal solutions
with a high added value to our customers for the pharmaceutical,
biotechnology and veterinary industries and research centers.
Biopuremax
HaSadnaot 4 st
46728 - Herzliya
Israel
P: +972 9 9716111
F: +972 9 9716112
Shlomo@biopuremax.com
www.biopuremax.com
The Biopuremax is a new type of pretreatment water system for RO
with no organic resins for softening, no carbon and no SBS for chlorine destruction. The system based on electrical scale precipitation
and UV destruction of chlorine. All the system is hot water sanitized
(full SS construction) It has no backwash, no regeneration and no
chemical dosing. The system is revolutionary in the fact that it has
no moving parts, no regenerations, no chemicals, no contamination
and no waste stream. The system is reliable as it is simple, no tuning
or adjustments are needed after the design and installation.
2016 PDA Europe
Pharmaceutical
Freeze Drying
Technology
27-28 September 2016
Strasbourg | France
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EXHIBITOR ABSTRACTS
Bonfiglioli Engineering S.r.l.
Via Rondona, 33
44049 Vigarano Pieve (Ferrara)
Italy
Tel: +39 0532 71 56 31
Fax: +39 0532 71 56 25
marketing@bonfiglioliengineering.com
www.bonfiglioliengineering.com
groninger & co. gmbh
Hofaeckerstrasse 9
74564 - Crailsheim
Germany
P: +49 7951 495 0
F: +49 7951 495 3138
info@groninger.de
www.groninger.de
Bonfiglioli Engineering, leader in manufacture of inspection equipments, has developed an advanced expertise in Container Closure
Integrity Testing, Visual Inspection and Headspace Gas Analysis
context, addressing both quality and safety of all container systems, for Laboratory and Inline container integrity testing for laboratories as well as in-line container integrity testing. After over 40
years of planning and manufacturing innovation, BE prides itself on
a perfect combination of production stability, testing efficiency and
maintenance simplicity. The machines, custom-made to customers
specifications with top quality standards and proven technologies,
are built to be used in all production conditions and designed to be
easily managed through intuitive interface boards and fast format
changes. BE’s innovative machines are cost, time and space-effective. They guarantee high quality, safe products to the end-user
while protecting manufacturers from financial loss due to recalls,
lawsuits and potential adverse publicity.
Filling and packaging machines for the pharmaceutical, consumer healthcare and cosmetic industry. groninger is a successful, experienced and dynamic company with around 1000 employees
worldwide, focused on developing and manufacturing specialized
machines for accurate filling and secure closing of liquid pharmaceutical products, especially in pre-sterilized syringes, vials and bottles.
Working close with the customer, groninger develops and realizes
the optimal solution for the customers' requirements! The groninger
machine program ranges from: fully automated syringe processing
lines with tray loading / unloading, washing, filling, gassing, piston
rod insertion, checking, labeling as well as label control ñ speeds up
to 60.000/h; liquid filling lines for vials and bottles including washing
station, sterilization tunnel, filling, stoppering, labeling, label control
as well as capping ñ speeds up to 48.000/h; eye drop filling and closing lines with the latest technology and speeds up to 24.000/h; highly
flexible filling and closing lines for consumer healthcare, diagnostics
and other non-aseptic liquid products in plastic and glass containers; isolator compatible filling machines; peripheral equipment for
filling and closing lines, including container and component sorting
and feeding equipment and robotic sorting and feeding solutions.
Gateway Analytical
5316 William Flynn Highway
15044 - Gibsonia
United States
P: +1 724 443 1900
F: +1 866 658-1445
lehrp@gatewayanalytical.com
www.gatewayanalytical.com
Gateway Analytical is a contract analytical laboratory and consulting company offering the pharmaceutical, materials science and
forensics industries expertise by using conventional and innovative
analytical testing techniques. Gateway Analytical is FDA registered,
cGMP complaint, DEA licensed, and ISO 17025 certified. We ensure
that all testing is performed to provide results efficiently and effectively, while maintaining the highest quality standards. Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.
IWATA LABEL Europe
Königsallee 92a
40212 - Düsseldorf
Germany
P: +49 211 5403 9784
toshiaki_kurihara@iwatalabel.co.jp
www.iwatalabel.com
IWATA LABEL Europe GmbH is a specialty manufacturer of adhesive
labels and labeling machines for pharmaceutical products. Our
products add high value and multiple functions to pharmaceutical
labeling needs. The need for labeling solutions, which protect medical staff, greatly helps us focus on innovation and develop new products and services.
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EXHIBITOR ABSTRACTS
LIGHTHOUSE Instruments
Science Park 408
1098 XH Amsterdam
The Netherlands
P:+31 6 4226 7380
euinfo@lighthouseinstruments.com
www.lighthouseinstruments.com
LIGHTHOUSE is the leading global provider of laser-based headspace analysis systems. Headspace applications include: 100%
container closure integrity (CCI) inspection, off-line CCI testing, IPC
of headspace oxygen during filling and for stability studies, lyo cycle optimization, lyo chamber moisture mapping, and automated
media fill inspection. LIGHTHOUSE offers a range of benchtop and
in-line platforms with patented laser sensor technology commercialized with the help of funding from the Food and Drug Administration. In addition, analytical services are delivered from laboratory
facilities in Amsterdam and Charlottesville, Virginia.
Malvern Instruments
Enigma Business Park, Grovewood Road
Malvern
WR14 1XZ Worcestershire
United Kingdom
Phone: +44(0) 1684 892456
Fax: +44 (0) 1684 892789
stephane.rouquette@malvern.com
www.malvern.com
Malvern Instruments proposes a full range of instruments to characterize proteins and macromolecules:
• Zetasizer, DLS & SLS for size, molecular weight, protein charge;
• NanoSight NTA, concentration;
• OmniSEC, molecular weight/structure;
• MicroCal, binding parameters;
• Viscosizer, size and viscosity.
For Visible and Sub visible particles:
• The Morphologi G3ID:
An automatic microscope platform associated with Raman Spectrometer to measure concentration, size, shape and chemical ID of
particles from 1 to 1000 µm.
• The Archimedes:
RMM (Resonant Mass Measurement) technique, to measure mass,
concentration and buoyancy (protein versus silicon oil) of protein
formulations from 0.2 to 5 µm.
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Merck
Frankfurter Straﬂe 250
64293 Darmstadt
Germany
Tel.: +49 (0) 6151 72-0
Fax: +49 (0) 6151 72-2000
service@merckgroup.com
www.merckgroup.com
Merck a leading science and technology company in life science,
offers products used by pharmaceutical and biotechnology companies to develop and manufacture drugs safely and efficiently. We
provide excipients, APIs, complex API manufacturing services and
critical raw materials to support all stages of the drug manufacturing process from research to industrial-scale production and quality
control. Our products meet the highest purity standards with extensive documentation and services to assure regulatory compliance.
NARA Machinery Co., Ltd.
Europaallee 46
50226 - Frechen
Germany
P: +49 2234 2776 0
F: +49 2234 2306 7
contact@nara-e.de
www.nara-e.de
For more than 90 years supporting companies from various industries all over the world with solving their challenges in matters of
powder treatment. Specialized in drying, milling, mixing and particle
design we believe to provide our customers and partners the best
know-how to meet their expectations.
Novatek International
2537 Rue Guenette
H4R 2E9 Montreal
Canada
P: 1-514-668-2835
F: : 1-336-6537
sales@ntint.com
www.ntint.com
Novatek is regulatory compliant software provides the building
blocks for a complete quality management solution that can be
tailored to any clientís needs. Our software can be used as standalone modules or integrated with other modules to form large-scale
comprehensive solutions. With 20 years of successful installations
worldwide, Novatek has developed an extensive base of regulatory
knowledge ensuring compliance and peace of mind during audits for
our clientele. Build your solution with the flexibility to grow with your
needs and implement at your pace!
EXHIBITOR ABSTRACTS
NSF Pharma Biotech
The Georgian House, 22/24 West End,
Kirkbymoorside
York, YO62 6AF
United Kingdom
Tel: +44 1751 43 29 99
Fax: +44 1751 43 24 50
pharmamail@nsf.org
www.nsf.org
NSF Health Sciences Pharma Biotech is a major global provider of
pharmaceutical education, consultancy, auditing and analytical
testing. Our education programs include GMP courses, QP Training,
Sterile Manufacture, Human Error Prevention and IRCA certified QMS
auditor courses. NSF provides consultancy for GMP/GDP compliance, quality management systems and regulatory enforcement action support. We conduct mock regulatory inspections, supplier audits and certification. Our mission is to work in partnership with our
clients to add value through • Improving efficiency and operational
excellence through simplification of quality systems and processes •
Helping companies adopt standards that are fit for purpose through
benchmarking • Supporting companies in preparing for future challenges (business and regulatory) to stay ahead of their competition •
Educating employees to improve business performance, robustness
and flexibility • Guiding companies to change their culture!
Omori Europe
Eektestraat 1
7575 AP - Oldenzaal
The Netherlands
P: +31 541 582026
F: +31 541 520595
info@omorieurope.com
www.omori.co.jp
Omori supply a wide range of state-of-the-art stretch and flow wrappers (HFFS) for different, creative and innovative packaging. We are
a leader in the food and pharmaceutical industries. The packaging
machines can be combined with different automated input systems,
to provide a turnkey packaging system. The combination of high
quality equipment with creative packaging solutions, gives a beautiful and luxurious look to your product, with distinctive character.
The advanced, Japanese machines of Omori comply with the European directives and components can be specified to suit the customerís requirements.
OMPI
Via Molinella 17
35017 - Piombino Dese
Italy
P:+39 049 9318111
F:+39 049 9366151
info@ompipharma.com
www.ompipharma.com
Ompi is the Pharmaceutical Systems division of Stevanato Group.
OMPI boasts a unique expertise in providing superior pharmaceutical containers from glass tubing. Its comprehensive portfolio covers every customer need, from those related to small molecules to
highly sensitive drugs: syringes, pen and dental cartridges, injection
and lyophilization vials and ampoules. Syringes, cartridges and vials
are produced both in bulk and sterile format (www.ez-fill.com). Ompi
EZ-fill concept is a solution that provides the pharmaceutical vials,
cartridges or syringes already washed, sterilized ready to be filled by
simplifying the traditional production process. Ompi also provides
customized containers, all manufactured to the highest standards.
PQE Deutschand GmbH
Landshuter Str. 55
85435 - Erding
Germany
P: +49 8122 17750 60
F: +49 8122 17750 61
de.info@pqe.eu
www.pqe.eu
PQE is a Contract Quality Organisation and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 10,000
projects world wide and now serve our Clients from offices in Italy,
Spain, Germany, Switzerland, US, LATAM, the Middle East and China.
As an international company we have experience working in more
than 15 languages and have an excellent history of supporting small,
medium and large size companies exceed compliance standards
from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA and other
local authorities.
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EXHIBITOR ABSTRACTS
PTI Inspection Systems 145 Main Street
10707 - Tuckahoe
United States
P: +1 914 337 2005
F: +1 914 337 8519
info@ptiusa.com
www.ptiusa.com
rommelag ag
Fabrikweg 16
5033 - Buchs
Switzerland
P: +41 62834 5555
F: +41 62834 5500
mail@rommelag.ch
www.rommelag.com
PTI Inspection Systems is the leading manufacturer of non-destructive package quality inspection technologies for package integrity
testing, seal integrity, leak testing and container closure integrity
testing (CCIT). PTI technologies include vacuum decay, airborne ultrasound and high voltage leak detection. Our technologies are deterministic, quantitative test methods that exclude subjectivity from
package testing, and use test methods that conform to ASTM standards. PTI Inspection systems provide repeatable, reliable results
and can be used at any point in the manufacturing process as they
are non-destructive, non-invasive and require no sample preparation.
rommelag the inventor of Blow-Fill-Seal (BFS) Technology is the
worldwide leading manufacturer and supplier of bottelpack aseptic
machines for the packaging of sterile liquids. The bottelpack machines are cGMP and FDA compliant. bottelpack aseptic machines
have an integrated clean room class A (US-class 100). The machine
capacity goes up to 30,000 containers / hour with volumes from 0.1
ml to over 1,000 ml. Plastic materials used are LDPE, MDPE, HDPE,
PP, PET and others. We offer tests and contract fillings in our own
laboratory and production utilities. rommelag is certified according
to the new standard DIN EN ISO 9001: 2000.
rap.ID Particle Systems GmbH
Köpenicker Str. 325, Haus 11
12555 Berlin, Germany
Tel: +49 30 6576 3440
Fax: +49 30 6576 3441
information@rap-id.com
www.rap-id.com
Saint-Gobain
11400A 47th Street N
33762 - Clearwater
United States
P: +1 727 540 1060 227
linda.f.potter@saint-gobain.com
www.biopharm.saint-gobain.com
As one of the world's largest manufacturers of high performance
Logo analysis
Sonnenhof
- Farbwerte:
rap.ID creates fully GMP compliant
instruments
for particumaterials, Saint-Gobain Bioprocess Solutions is leading the way in
Blau =theCstandard
100%/inMpre-filled
30%/ Y
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late identification and has defined
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critical fluid management. Our Collaborative Design Services devel= C 0%/ M
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lubrication control. rap.ID isGelb
the technological
leader
in the
identifi- K 0%
op customized single-use systems tailored to your bioprocess. We
cation of contamination particles as it is the only company worldwide combining micro Raman and LIBS in one instrument. Using its
pharmaceutical industry experience rap.ID provides contract testing
and method development and validation from its FDA inspected laboratories in USA and Germany. With over 5.000.000 identified particles within the last 14 years rap.ID became a global institution for
the root cause analysis of visible and sub visible particulate matter.
are the developer and manufacturer of industry standards: C-Flex,
PharmaFluor, PharmaPure, Pure-FitÆ and Sani-Tech.
S ONNENHOF
PDA Europe supports the children's hospice „Sonnenhof”
The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support and assistance
to families with children suffering from incurable and/or debilitating diseases.
At Sonnenhof, children, together with their families, can spend the time they have left as
they wish and find some relief from their suffering.
Instead of purchasing expensive gifts for the conference speakers, PDA has decided to
donate this amount to the Sonnenhof Hospice. You can also contribute and help us increase the amount, it is easy: buy a package of chewing gums at the registration desk.
THANK YOU!
To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de
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S ONNENHOF
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EXHIBITOR ABSTRACTS
STERIS Deutschland GmbH
Eupener Straße 70
50933 Cologne
Germany
T: +49 5136 97 06 12 2
F: +49 5136 97 06 12 1
andy_todd@steris.com
www.STERISLifeSciences.com
Toxikon Europe NV
Romeinsestraat 12
3001- Heverlee
Belgium
T: +32 16 400484
F: +32 16 401304
piet.christiaens@toxikon.be
www.toxikon.be
STERIS Corporation is a leading provider of infection prevention and
surgical products and services, focused primarily on critical healthcare, pharmaceutical and research markets around the world. The
Company supplies a broad array of equipment, consumable and
service solutions that help assure productivity and quality. STERIS
is listed on the New York Stock Exchange under the symbol STE. For
more information, visit www.steris.com. STERIS has a comprehensive offering of detergents, disinfectants, skin care products and
sterility assurance products that support your needs. We also have
world class technical support to design the most effective cleaning
program for your facility.
Toxikon is a comprehensive testing organization, ISO-17025 accredited, providing a complete suite of services for the qualification and
registration of medical devices, biomaterials and pharmaceuticals.
Toxikon Europe is a subsidiary of Toxikon Corporation, a US based
GLP-laboratory in Boston, covering the complete range of biocompatibility and toxicology services. Toxikon Europe operates a stateof-the-art facility in Leuven, Belgium and specializes in the safety
qualification of polymer materials (extractables studies, leachables
studies). Other capabilities are lot release testing, microbiology and
in-vitro toxicology procedures. All testing is performed according to
the most recent guidelines, International and European Standards.
Sponsor modified procedures, protocols, regulatory consultancy
and analytical interpretation are available on request.
TERUMO
Interleuvenlaan 40
3001 Leuven, Belgium
Tel: +32 16 38 15 73
Fax: +32 16 381 604
info@terumo-gps.com
www.terumo-gps.com
Founded in 1921 in Japan, Terumo is a global research & development company, offering a wide range of innovative products and
services related to drug delivery devices, cardiology and cardiovascular systems, transfusion, patient monitoring and clinical systems.
Terumo contributes to society by providing valued products and
services in the healthcare market and by responding to the needs
of healthcare providers and the people they serve. Unique technologies and advanced devices are being offered to the pharmaceutical industry in order to make medical treatment more comfortable,
kinder and gentler.
Veltek Associates Inc.
15 Lee Boulevard
19355 Malvern, PA
United States
Tel: +1 610 644 8335
Fax: +1 610 644 8334
vai@sterile.com
www.sterile.com
Veltek Associates, Inc. is a single source supplier for all of your contamination control needs. VAI manufactures a broad line of sterile
disinfectants, sporicides, cleaners and detergents in a variety of sizes. In addition to multiple sizes, these products are available in saturated wipe packs. Veltek Associates, Inc.'s capabilities also include
viable monitoring equipment. This product line consists of portable
devices, compressed air / gas sampling and single unit multi location systems with an assortment of capabilities. Cleaning devices,
laboratory services, cleanroom garments and consulting services
are all part of the contamination control solutions VAI has to offer for
every compliance challenge.
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EXHIBITOR ABSTRACTS
Watson-Marlow GmbH
Mühlenweg 9
41569 - Rommerskirchen
Germany
P: +49 2183 42040
F: +49 2183 82592
info@wmftg.de
www.wmftg.de
Watson-Marlow Fluid Technology Group (WMFTG) is the world leader
in niche peristaltic pumps and associated fluid path technologies for
the food, pharmaceutical, chemical and environmental industries.
Comprising nine established brands, each with their own area of expertise, but together offering our customers unrivalled solutions for
their pumping and fluid transfer applications. Customers demand
many things from their process equipment and the prime concern is
maintaining product integrity. Positive displacement pump companies such as Watson-Marlow Fluid Technology Group (WMFTG) need
to supply products which meet a range of requirements including:
value for money; low cost of ownership; reliability; ease of maintenance; and proven after sales service. We work closely with our
customers to demonstrate how our positive displacement pumps
ensure accurate metering, transfer and filling, can deliver significant
process efficiencies over the lifetime of the equipment. WMFTG is a
wholly owned subsidiary of Spirax-Sarco Engineering plc (LSE: SPX),
a global organisation employing approximately 5,000 people worldwide. Watson-Marlow Fluid Technology Group comprises nine established brands, each with their own area of expertise, but together
offering our customers unrivalled solutions for their pumping and
fluid transfer applications
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Deutschland GmbH & Co.KG
Stolberger Straße 21-41
52249 - Eschweiler
Germany
P: +49 2403 796 0
F: +49 2403 250
acsEurope@westpharma.com
www.westpharma.com
West Pharmaceutical Services is a leading manufacturer of packaging components and delivery systems for injectable drugs and
healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency,
reliability and safety of the world's pharmaceutical drug supply.
West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and
Australia
Wilco AG
Rigackerstr. 11
5610 Wohlen
Switzerland
Tel: +41 56 618 43 43
Fax: +41 56 618 43 44
info@wilco.com
www.wilco.com
WILCO AG provides in-line, off-line and laboratory machines with
non-destructive testing methods for monitoring the oxygen content
and container closure integrity simultaneously. Our patented leak
detection methods based on the process analytical technologies
(PAT) offers the opportunity for monitoring the finishing processes
as well.We have newly implemented Visual Inspection technologies
in our portfolio. With CCIT and Visual Inspection WILCO AG now covers all inspection expectations for pharmaceutical products and
our customers benefit from WILCO AG’s vast experience in quality
inspection.
The Parenteral Drug Association presents...
PDA Education
Program
30 June 2016
Test Methods for Pre-filled Syringe Systems
30 June 2016
30 June 2016
How to Find the Right GMP for APIs
30 June - 01 July 2016
Two-Day Training Course
30 June - 01 July 2016
Two-Day Workshop
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ONE-DAY TRAINING COURSE
Test Methods for Pre-filled Systems
Overview
Pre-filled Syringes (PFS) are used for different applications and throughout many therapeutic areas. They are
available in glass and polymer, with and without needles already pre-attached to the syringes. Pre-filled Syringes
fulfill two tasks: storage container and delivery device in one and the same system.
The more components are used in such systems the more complex it will get, additionally if such Pre-filled Syringes
are used in Auto-injectors or other delivery devices.
This one-day course will cover a short introduction into common materials used for the development and
manufacturing of syringe systems. The main focus is on the test methods which are relevant for the different stages of a Pre-filled Syringe.
Who Should Attend:
Learning Objectives:
This course will be beneficial to individuals working in Product Development, Quality Management,
Regulatory Affairs and Manufacturing of syringe
systems and related delivery devices
Upon completion of this course, you will be able
•
•
•
•
To understand the pros and cons of the different
materials used for the Pre-filled Syringe
To apply existing standards and monographs for
specific syringe testing
To explain the testing rationales used for test methods at different stages
To create a own testing plan according to your specific application
Horst Koller, CEO, HK Packaging Consulting GmbH
Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than
20 years industry experience. His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as
well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied
Sciences in Mannheim / Germany.
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TRAINING COURSE AGENDA
Thursday, 30 June 2016
9:00
Welcome
9:15
Introduction to Syringe Systems & Components
• Polymer Syringes
• Glass Syringes
• Rubber Components and Closures
9:00 – 17:00
10:15 Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes
11:00 Coffee Break
11:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling
• Cone Breakage
• Flange Breakage
• Leakage
12:30 Lunch Break
13:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling
(continued)
• Break-loose and Gliding Forces
• Needle Penetration
• Particulate Matter
• Endotoxins
14:30 Requirements for Finished Pre-filled Syringes
• Pharmacopoeia
• FDA
15:30 Coffee Break
16:00 Additional Testing for Use in Delivery Devices
• Auto-Injectors
17:00
End of Training Course
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A practical approach
Overview
This interactive course deals with all aspects of cleaning and disinfecting a sterile manufacturing facility. The
information shared will encompass regulatory aspects, Environmental Monitoring, contamination sources,
selection of disinfectants and cleaning agents, the validation and how they should be used properly.
Who Should Attend:
•
•
•
•
At the end of the workshop attendees should be able to
develop or evaluate an existing cleaning and disinfection
program in line with regulatory expectations and
facility’s requirements for contamination control of
classified areas.
Production management
Operators responsible for/involved in C&D
Quality/Microbiology management
Quality personnel involved in C&D
9:00
9:00 – 18:00
Welcome & Introduction
Subject Introduction | General Framework | Directives | Guidelines | Expectations
10:30
Coffee Break
Environmental Monitoring and Risk Analysis | Root Cause of Contamination
12:30
Lunch Break
13:30
Selection Criteria | Validation | Means and Methods
15:30
Coffee Break
Practical Approach | Supplies and Tools | Case Studies
18:00
Peter Koger, MSc., Technical Sales Manager International, Veltek Associates Inc.
Peter Koger has been active in life science for over 35 years. First 12 years were spend in different laboratories in microbiology and the
remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 20 years Peter
has been a technical resource to the pharmaceutical industry in relation to viable monitoring, cleaning & disinfection, and other aspects
related to Aseptic Manufacturing and Contamination Control. Since 2002, he is a frequent industry speaker and since 2004, Peter has
been a faculty member of PDA and other training institutes. Peter worked with several companies to help them get to best practice level
in Cleaning & Disinfection. Since 2005, Peter is working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focused on Contamination Control in the Pharmaceutical and Biotech industry. In his role, Peter is
Technical Sales Manager responsible for Europe and part of Asia.
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Advanced aseptic packaging in one operation cycle
Reliable – Simple – Cost-Effective
bottelpack® Technology:
• Integrated clean room US-class 100
• Recognized by GMP, FDA, JP …
• Aseptic packaging of liquids, creams,
ointments …
• Endless container designs in PE, PP…
Your beneﬁts:
• Tamper-proof packaging
• Easy to open
• Simple to use
• Shatter-proof, no splinter hazard
www.rommelag.com
rommelag ag
P.O. Box · CH-5033 Buchs, Switzerland
Phone: +41 62 834 55 55
Fax: +41 62 8345500
E-mail: mail@rommelag.ch
rommelag Kunststoff-Maschinen
Vertriebsgesellschaft mbH
P.O. Box 1611 · D-71306 Waiblingen, Germany
Phone: +49 7151 95811-0
Fax: +49 7151 15526
E-mail: mail@rommelag.de
rommelag USA, Inc.
27905 Meadow Drive, Suite 9
Evergreen CO 80439, USA
Phone: +1.303. 674.8333
Fax: +1.303.670.2666
E-Mail: mail@rommelag.com
rommelag Trading (Shanghai) Co., Ltd.
Room 104~107,1st Floor, No.510 Zhongshan South 2nd Road,
Xuhui District, Shanghai, 200032 P.R. China
Phone: +86 21 5153 4967, +86 21 5153 4968
Fax No.: +86 21 5153 4969
E-mail: romcn@rommelag.com
How to Find the Right GMP for APIs:
An ICH Q7 expert working group member instructs
Overview
When API manufactures received their own GMP guideline by ICH, an important step was reached since there are
significant differences between GMP requirements for Drug (Medicinal) Products and those for APIs.
This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and lay
out the appropriate GMP standard to be applied by API manufacturers. In particular, it will address GMP related
topics of quality, production, logistics, engineering and biotechnology.
PDA Europe is proud to offer participants this unique opportunity to receive first-hand knowledge, interpretation
and understanding of ICH Q7, and to ask questions to one of the ICH Q7 authors.
Who Should Attend:
This course is designed specifically for those involved or interested in the manufacturing of APIs,
the suppliers to API manufacturers or CMOs of APIs.
The targeted audience comes from:
Upon completion of this course, the attendee will be
able to:
•
•
•
•
•
Quality
Production
Logistics
Engineering
•
•
•
•
•
•
•
Avoid an over-interpretation of the GMP
requirements in API manufacturing
Know the keywords of the ICH Q7 guideline and how
to interpret the guideline correctly
Know the different responsibilities of quality and
production
Realize the additional GMP requirements for Biotechnology APIs
Understand the meaning of ‘critical’ and its impact
on quality processes
Determine at which point in API manufacturing GMP
needs to be applied
Know how materials are re-used in a correct manner
Know what needs to be documented and which
departments are involved
Lothar Hartmann, Ph.D., Managing Director, IQP Consulting
Lothar Hartmann served at Hoffmann-La Roche in numerous functions nationally and globally. Lothar acted as Global Head of “Pharmaceutical Quality Systems & External Relations”, interacting with regulatory health authorities and associations, and as “Global Head of
Knowledge Management”. He also acted as Head of Quality at Crucell Berne, a Johnson & Johnson Group of Companies, before he built
up his own company ‘IPQ Consulting’. Lothar Hartmann served for more than 10 years on the board of APIC/CEFIC as Vice-Chairman. In
this function, he was nominated for the ICH Q7a Expert Working Group, writing the worldwide-harmonized GMPs for APIs. In this effort,
he also was FDA awarded in May 2004. He also founded and chaired the internationally recognized EBEs BioManufacturing Working Group for a number of
years. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises). He also served on
the PDA Board of Directors, chaired the European Interest Group on Quality Systems and was co-founder of PDA’s “Paradigm Change in Manufacture” (PCMO)
project which had the objective to address practical solutions for the day-to-day business of the new paradigm of ICH Q8 – Q11. Lothar Hartmann graduated
from the Technical University of Berlin.
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9:00
Welcome & Expectation Round of Participants
9:30
Regulatory Environment for APIs
10:00
Quality
10:30
Coffee Break
11:00
Workshop (Draw Flowchart for Handling Deviations / Investigations)
11:30
Discussion of Outcome of Workshops
12:00
Keywords of ICH Q7
12:30
Lunch Break
13:30
Documentation
14:00
Workshop (Key Items of Major SOPs)
14:30
Discussion of Outcome of Workshops
15:00
Coffee Break
15:30
General GMPs for Production, Logistic & Engineering
16:00
Re-use of Materials
16:30
Special Requirements for Biotechnology
17:00
Final Discussion Round
17:30
9:00 – 17:30
#pdaeuannual
31
TWO-DAY TRAINING COURSE
Root Cause Investigation for CAPA
Overview
Root Cause Investigation for CAPA is an informative, practical, and engaging two-day workshop teaching a systematic, science based, and proven methodology ideal for investigating any performance change. Examples: change
in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical
or virtual), escalated customer complaints, etc. Based upon 40+ years’ experience, the methodology integrates
problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure,
analyze, improve, control), as well as other problem solving and process improvement techniques.
On day one, the participants are introduced to the seven step root cause investigation methodology. An Investigation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each
step is presented leveraging an instructor case study, the participants immediately apply the learning on their
own case study (which is based upon a real life investigation). On day two, several hours are devoted to strengthening the participants’ skills leveraging the methodology through practice on another, more complex, real life
case study. As the participants work on this case study they will compare their work with that of the investigation
conducted by the real team.
Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide
the investigator through the methodology and provide the basis for documentation.
Who Should Attend:
Alumni of this program typically (though not exclusively) have a background in:
Upon completion of the workshop, participants will
able to immediately, effectively, and efficiently apply
the methodology to:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Quality
Risk management
Regulatory affairs
Compliance
Manufacturing
Product development
CAPA
Supply chain & purchasing
Production
Engineering
Project management
R&D
Fraud management
and more
•
•
•
•
Identify the technical root cause(s), that is, the
change(s) that occurred.
Identify systemic root cause(s), that is, any underlining breakdown in the organizations broader systems
that allowed the change(s) to occur.
Implement a comprehensive corrective and/or preventive action plan to restore performance.
Implement a control plan to minimize and/or prevent recurrence.
Rob Weaver, President of Weaver Consulting
Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and operations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years’ experience
and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including
pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecommunications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause
Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob
with Wells Fargo & Company.
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#pdaeuannual
9:00
9:00 – 18:00
Welcome & Introduction
•
•
•
•
Define technical CAPA problem
Common investigation mistakes
Investigation Roadmap template
Introduce 1st participant real life case study
Friday, 1 July 2016
9:00
Introduce instructor case study
Problem statement
Problem description
10:30
Coffee Break
11:00
Step 1 Continued
•
•
•
•
•
•
Problem description continued
Workshop
Flow chart process(es) being investigated & identify key
inputs
Workshop
Time of events
Team charter including performance & cost savings goals
12:00 Lunch Break
13:00 Step 2: Collect Data
•
•
•
•
Determine data needed
Data collection tools & techniques
Data measurement plan
Workshop
10:30
11:00
13:00
•
•
•
•
•
•
•
16:30
Introduction
Workshop to develop problem statement, problem
description, identify possible causes
Workshop to collect data
Workshop to test possible causes
Coffee Break
15:30
Second Participant Real Life Case Study
Continued
•
13:00
•
•
•
•
•
•
16:30
Workshop to determine corrective/preventive actions
including risk mitigation, control plan, acceptance
criteria
Closing Remarks
•
Test possible causes against facts
Summarize testing leveraging contradiction matrix
Historical perspective of investigations
Workshop
Verify assumptions
Conduct studies/experiments
Identify technical root cause(s)
Second Participant Real Life Case Study
15:00
Step 5: Identify Technical & Systemic Root
Causes
•
•
•
Implement & measure corrective/preventive actions
Evaluate control plan
Determine additional preventive actions
Lunch Break
•
•
Step 4: Test Possible Causes
•
•
•
•
17:30
Time of changes
Differences between Is & Is Not facts
Workshop
Changes associated with identified differences
Review risk analysis
Brainstorming techniques
Workshop
Risk mitigation
Control plan
Workshop
Step 7: Verify Corrective/Preventive Actions
•
•
15:00 Coffee Break
15:30 Step 3: Identify Possible Causes
Step 6 Continued
•
•
•
12:00
Mistake proofing techniques
Variation reduction & optimization techniques
Corrective/preventive actions
Acceptance criteria
Coffee Break
•
•
•
11:45
dentify systemic root causes
Step 6: Determine Corrective/Preventive
Actions
•
•
•
•
10:00 Step 1: Define the Performance Problem
•
•
•
Step 5 Continued
•
9:30
9:00 – 16:30
Compare/contrast this investigation methodology
with traditional approach
Shortcuts
Simple investigations
Difficult investigations
Investigation report
Return on investment
References
End of Course
18:00 End of Day 1
#pdaeuannual
33
TWO-DAY WORKSHOP
Including hands-on exercises with equipment for processing,
inspection and control
Overview
This two-day workshop will provide an overview of relevant practical aspects and trends of
developing and processing pre-sterilized primary packaging systems. It will also focus on hot
topics such as aseptic environments, particulates, silicone and single-use filling. In addition to
theoretical insights, participants will have the opportunity to use equipment and perform testing
by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be
demonstrated using state-of-the-art technology.
Who Should Attend:
This course offers valuable insights and updates
for anyone involved in development, production,
quality, and purchasing of pre-filled syringes and
relevant equipment
You will learn how:
•
•
Processes involved in primary packaging manufacturing, filling and processing influence quality
Relevant equipment can be used to achieve
reproducible quality
Faculty
Moderator:Christa Jansen-Otten, Director Marketing PFS Europa, West Pharmaceutical Systems
Horst Koller, CEO, HK-Packaging Consulting
Speaker:Simone Biel, Field Marketing Specialist, Merck Millipore
Maurizio Trombetta, Sales Manager, Metall + Plastic
Oliver Valet, Managing Director, rap.ID
Josef Veile, Director Engineering and Design, Groninger
Patrizia Wenzel, Sales Manager, Biesterfeld Spezialchemie
34
#pdaeuannual
WORKSHOP AGENDA
9:00 – 17:45
9:00
Welcome and Introduction
West
9:15
Market Overview and Trends in Primary Packaging:
• Global & Regional Pharmaceutical Market / Injectable Market /
Challenges / Changes in Manufacturing / Devices
West
9:45
The Complete Process to Manufacture Pre-filled Syringes Josef Veile,
From Washing to Packaging, Part I:
Groninger
• Material / Forming / Cleaning / Siliconization / Pre-Assembly / Sterilization
10:45
Coffee Break
11:15
The Complete Process to Manufacture Pre-filled Syringes From Washing to Packaging, Part II:
• Unpacking / Filling / Control & Close / Labelling / Packaging
Josef Veile,
Groninger
11:45
Single-Use in Final Filling:
• Process Design
• Quality Considerations
Simone Biel,
Merck Millipore
12:30
Lunch Break
13:30
Silicone: “The Chemistry Behind It” / Chemical and Physical Aspects
14:00
Control of Silicone Layer and Particulate Matter:
Oliver Valet,
• Technology / Lubrication control / Investigation strategy / Distribution
rap.ID
and stability measurement / Relationship between silicone oil distribution
and protein aggregation / Good Particles Investigation Practice /
Visual classification / Documentation / Microscopy /
Raman, LIBS, IR/ATR- Spectroscopy
14:45
Coffee Break
15:15
Hands-On Training using Industry Equipment:
• Silicone distribution (rap.ID)
• Siliconization (Groninger)
• Silicone chemical/physical aspects (Biesterfeld)
• Single Use (Merck Millipore)
• Filling (Groninger)
Practical Training
provided by various
suppliers
17:15
Q & A, Open Discussion
All
17:45
End of Day 1
Patrizia Wenzel,
Biesterfeld Spezialchemie
#pdaeuannual
35
WORKSHOP AGENDA
Friday, 1 July 2016
36
8:30 – 16:45
8:30
A Comparison of Pre-filled Syringes Filling Operations in RABS and
Isolators
Maurizio Trombetta,
Metall + Plastic
9:15
Material, Manufacturing, Process and Quality Effects
on Glass:
• Polymers / Coating / Multilayer
Horst Koller,
HK Packaging
10:00
Coffee Break
10:30
Elastomeric Closures for Pre-filled Syringe and Cartridge Applications:
• Manufacturing / Requirements / Coatings / Quality / Extractable /
Regulatory / Adopted Packaging
West
11:30
Comparing Different Solutions on Nested Containers
• BD / Gerresheimer / NIPRO / OMPI / Schott / West
Horst Koller,
HK Packaging
12:00
Q&A on Nested Packaging
Horst Koller,
HK Packaging
12:15
Development and Regulatory Aspects of Primary Packaging Material:
Transfer from Vial into Syringe
Horst Koller,
HK Packaging
13:15
Lunch Break
14:15
Hands-On:
• Stoppering (Groninger)
• Particle Identification (rap.ID)
• Primary Packaging (West)
• Packaging and Components (HK Packaging)
Practical Training
provided by various
suppliers
16:15
Q & A, Open Discussion
All
16:45
#pdaeuannual
Special Offer
for PDA Europe
Annual Meeting
Attendees
JOIN PDA TODAY AND SAVE!
Get $909
for just $259
Visit the PDA Lounge for more information
…and see how PDA can help boost your career.
INFORMATION
VENUE
Estrel Berlin
Sonnenallee 225
12057 Berlin
Germany
Tel.: + 49 (0) 30 683 10
CO N TAC T I N FO R M AT I O N
Conference Inquiries
Melanie Decker
Director Events & Exhibitions
decker@pda.org
Conference Program Inquiries
Sylvia Becker
Manager Programs & Events
becker@pda.org
Registration & Customer Care
Tel: + 49 30 4365508-10
registration-europe@pda.org
Education Program Inquiries
Elke von Laufenberg
Manager Training & Education
laufenberg@pda.org
Exhibition/Sponsorship Inquiries
Creixell Espilla-Gilart
Manager Exhibition & Sponsorship
espilla@pda.org
38
#pdaeuannual
ORGANIZER
PDA Europe gGmbH
Am Borsigturm 60
13507 Berlin, Germany
Tel: + 49 30 4365508-0
Fax: + 49 30 4365508-66
info-europe@pda.org
E X PLO R E B E R LI N!
PDA Europe is proud to offer you additional opportunities to
explore Berlin whilst you are here! Don't miss experiencing some
of the cultural variety Berlin has to offer.
Partnering with PDA Europe, Art Berlin, a renowned tourism
agency, has put together some activities for you to choose from.
Make your stay in Berlin even more memorable and unique!
SOCIAL MEDIA
Hints for Using Social Media
We would like to encourage you in using Social Media Portals and to fuel the dialogue about
PDA Europe and the ‘‘1st PDA Europe Annual Meeting’’
PDA Europe is active on Twitter @PDA_Europe and LinkedIn PDA-Parenteral Drug
Association Group.
For this meeting we are using the hashtag #pdaeuannual to upload all content related to
this conference on these platforms.
By joining LinkedIn and Twitter and using them to promote your participation in all of our
events, you can actively help increase the number of participants to any given event while
also drawing attention to your own company and to your personal profiles. Thus, together we
will maximize your exposure to the leaders and key decision makers of the pharmaceutical
and biopharmaceutical industry!
Before, during, and after the “1st PDA Europe Annual Meeting” the hashtag #pdaeuannual will
be used to mark and identify event related tweets. This is perfect to let everybody know about your
involvement!
By using the hashtag #pdaeuannual, you further ensure that all tweets are collected under this topic, therefore
creating a permanent history of all related tweets.
Example Tweet: “Our company will be exhibiting at the 1st PDA Europe Annual Meeting #pdaeuannual this
year! Visit our booth in Hall C! @PDA_Europe”
Or “See our newest product at the 1st PDA Europe Annual Meeting #pdaeuannual @PDA_Europe” – you can add
a link, a video or even a pdf presenting your product! There are many way of using this channel, feel free to post
pictures, videos and the like.
You can also create a hashtag and / or account of your own company to link your posts.
The PDA - Parenteral Drug Association Group and 1st PDA Europe Annual Meeting Group are open
to everyone on LinkedIn. Please join these groups and become part of interesting discussions, raise
questions, show your involvement, interact with your peers and be present!
Example Content: “Looking for a cost-reduction on your primary packaging? We will be at the #pdaeuannual
conference – visit us at table-top Nr. XXXX and get the chance to win an ipad/prize/whatever you want to give/
together with the best instrument for your new drug launch!’’ You can post a link to your own website, video
on you tube, PDF brochure…
#pdaeuannual
39
Save the Date
PDA Europe
2 Annual Meeting
nd
13-14 June 2017

Meeting Guide

Transcription

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