2016 PDA Visual Inspection Interest Group Workshop

The Parenteral Drug Association presents the...
2016 PDA Visual Inspection
Interest Group Workshop
Take part in an interactive Visual Inspection Interest Group Workshop
May 18, 2016 | Bethesda, MD
PDA Training and Research Institute
Courses: May 16-17 and May 19-20
Workshop Theme: Discussing Current Topics
in Visual Inspection
pda.org/2016VisualWorkshop
#2016Visual
This preliminary agenda is current as of February 17, 2016
RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS
2016 PDA VISUAL INSPECTION INTEREST GROUP WORKSHOP
Connecting People, Science and Regulation®
PROGRAM PLANNING
COMMITTEE
A MESSAGE FROM THE PROGRAM CHAIR
Program Chair
John Shabushnig, PhD
Insight Pharma Consulting, LLC
John Ayres, MD
Eli Lilly & Company
Roy Cherris
Bridge Associates International
Markus Lankers, PhD
rap.ID GmbH
Rick Watson
Merck Sharp & Dohme Corporation
PDA Staff:
Janie Miller
PDA
Jason Brown
PDA Liaison to the Program Planning
Committee
John Shabushnig, PhD
Insight Pharma
Consulting, LLC
For the first time in the U.S., PDA will hold a full-day Visual
Inspection Interest Group Workshop! This format will permit
focused discussion on a small number of specific topics. For
this Workshop, we have chosen to focus on two topics. In the
morning, we will discuss the implementation of the new USP
General Chapter <790> Visible Particulates in Injections, including
the requirements for supplemental testing, unique requirements
for biopharmaceutical products and acceptance sampling
to assess batch quality. In the afternoon, we will discuss the
transition from manual visual inspection to automated visual
inspection, including validation requirements and strategies,
the application of 2-stage inspection strategies, and how
semi-automated visual inspection fits into the spectrum of
inspection technologies.
A further goal of this Workshop is to build a network of experts and interested professionals
working in this important and specialized field. Attendance will be limited, so there will be
a good opportunity to meet and interact with your industry peers. You will be able to share
your experiences and learn from others in attendance. This will also allow time to discuss
your specific questions and concerns within the topics identified above. Please register early
to ensure your space in the Workshop.
We are also pleased to offer two optional two-day training courses through the PDA
Education Department. An Introduction to Visual Inspection course, May 16-17, covers the
basics of visual inspection, establishing and managing a visual inspection program, and
qualification and validation of inspection processes as applied to injectable products. This is
a hands-on laboratory course allowing exploration of the practice of visual inspection along
with its theory. The skills developed through this course may be applied to both manual
human inspection and automated machine inspection. The Foreign Particulate Examination,
Isolation and Analysis course, May 19-20, combines lecture/discussion and hands-on
laboratory exercises to develop practical inspection skills for both manual human and
automated machine inspection.
We look forward to seeing you at this exciting and informative Workshop.
2
Continuing Education Credits
GENERAL INFORMATION, REGISTRATION
Workshop Registration Hours
Four Ways to Register
1. CLICK
www.pda.org/2016visualworkshop
2. FAX
+1 (301) 986-1093
3. MAIL
PDA Global Headquarters
Bethesda Towers
4350 East West Highway, Suite 600
Bethesda, MD 20814 USA
4. PHONE
+1 (301) 656-5900 ext. 115
Venue
PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA
Phone: +1 (301) 656-5900
Recommended Hotel
Accommodations
A list of recommended hotels are shown below.
To secure the PDA Rate, reservations must be
made over the phone.
Hilton Garden Inn Bethesda
7301 Waverly Street, Bethesda, MD 20814
0.3 miles from PDA
Phone: +1 (301) 654-8111
* Use code N0033113 when making your reservation
via phone. Rates are subject to availability.
Hyatt Regency Bethesda
One Bethesda Metro Center, Bethesda, MD 20814
0.4 miles from PDA
Phone: +1 (301) 657-1234
* Use code 78056 when making your reservation
via phone. Rates are subject to availability.
Hilton Rockville Hotel and Executive
Meeting Center
1750 Rockville Pike, Rockville, MD 20852
7 miles from PDA
Phone: +1 (301) 468-1100
* Use code N2703011 when making your reservation
via phone. Rates are subject to availability.
Wednesday, May 18, 2016:
7:30 a.m. – 12:00 p.m.
Course Registration Hours
An Introduction to Visual Inspection
Monday, May 16, 2016: 7:30 a.m. – 9:00 a.m.
Foreign Particulate Examination,
Isolation and Analysis
Thursday, May 19, 2016: 7:30 a.m. – 9:00 a.m.
Dress/Attire
Business casual attire is recommended for
the 2016 PDA Visual Inspection Interest Group
Workshop. Casual attire and comfortable shoes
are recommended for the 2016 Visual Inspection
Course Series. Since the temperature in the facility
tends to be cool, please bring a jacket or sweater
for your comfort.
Special Requirements
If you require special accommodations
to fully participate, please attach a
written description of your needs with your
registration form. Specific questions can be
directed to registration@pda.org.
Contact Information
Workshop Inquiries
Jason E. Brown
Manager, Programs & Registration Services
Tel: +1 (301) 656-5900 ext. 131
Email: brown@pda.org
Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org
Education Course Series Inquiries
Kimberly McIntire
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900, ext. 103
Email: mcintire@pda.org
PDA is accredited by the
Accreditation Council for
Pharmacy Education (ACPE) as a
provider of continuing
pharmacy education. Participants may sign
up to receive Continuing Pharmacy
Education (CPE) credits. To do so, participants
must sign in at the beginning of the program,
submit the provided evaluation forms and
mail the CPE credit request to the address
stated on the form. Attendees must be
present at the full event to receive CPE credit.
ALERT: ACPE and the National Association
of Boards of Pharmacy developed the
Continuing Pharmacy Education (CPE)
Monitor that allows pharmacists to
electronically track their CPE credits. The CPE
Monitor will reject any CPE credit requests
submitted past 60 days from date of ACPE
accredited activity. Always submit CPE
activity claims as soon as possible and by
the deadline specified on the CPE credit
request form.
2016 PDA Visual Inspection Interest
Group Workshop
CPE: ACPE #0116-0000-16-006-L04-P |
0.6 CEUs
Type of Activity: Knowledge
Learning Objectives
At the completion of this Workshop, you will
be able to:
• Identify the requirements of USP <790>
Visible Particulates in Injections, including
requirements for supplemental testing
and biopharmaceutical products, and
acceptance sampling to assess
batch quality
• Explain the transition from manual
visual inspection to automated visual
inspection, including validation
requirements and strategies, application
of 2-stage inspection strategies, and how
semi-automated visual inspection fits into
the spectrum of inspection technologies
Who Should Attend
Departments:
Engineering | Manufacturing | Packaging |
Process Development | Quality | Technical
Services | Validation Pharmaceutical/
Biopharmaceutical Developers Clinical
Supplies | Parenteral Development | Process
Development Inspection Equipment Suppliers
Applications Development | Machine
Design | Sales
Courses: May 16-17 and May 19-20
WEDNESDAY, MAY 18, 2016 AGENDA
7:30 a.m. – 12:00 p.m.
Registration Open
7:30 a.m. – 8:30 a.m.
Continental Breakfast
8:30 a.m. – 10:00 a.m.
Welcome & Morning Session: Implementation
of USP <790>
Moderator: John Shabushnig, PhD, Principal Consultant,
Insight Pharma Consulting, LLC, and Chair, 2016 PDA Visual
Inspection Interest Group Workshop Program
Planning Committee
Session Description: This session is designed to review and
discuss the experience gained since the USP General Chapter
<790> Visible Particulates in Injections went into effect on August
1, 2014. We will include discussion of the practical aspects
of implementing and complying with this chapter. Special
consideration will be given to discussion on supplemental
testing of difficult-to-inspect product formulations and
containers and the unique challenges of biopharmaceutical
products. We will also include the use of acceptance sampling
to assess batch quality and compliance with the new chapter.
8:30 a.m. – 8:45 a.m.
Welcome & Introduction of the Workshop
John Shabushnig, PhD, Principal Consultant,
Insight Pharma Consulting, LLC
8:45 a.m. – 9:15 a.m.
Update on USP <790>
Desmond Hunt, PhD, Senior Scientific Liaison, USP
9:15 a.m. – 10:00 a.m.
Q&A/Discussion
10:00 a.m. – 10:30 a.m.
Refreshment Break
10:30 a.m. – 12:00 p.m.
Morning Session Continued: Implementation
of USP <790>
Moderator: John Shabushnig, PhD, Principal Consultant,
Insight Pharma Consulting, LLC
Session Description: This session picks up where the previous
session left off with discussion of the practical aspects of
implementing and complying with USP <790>, testing of
difficult-to-inspect product formulations/containers and more.
12:00 p.m. – 1:15 p.m.
Lunch
1:15 p.m. – 2:45 p.m.
Afternoon Session: Transition from Manual
to Automated Inspection
Moderator: Roy Cherris, Managing Partner,
Bridge Associates International
Session Description: The afternoon session will focus on best
practices and challenges associated with implementation and
qualification of automated inspection equipment. The session
will include discussion on approaches for automated inspection
equipment qualification and the design of container sets used
in qualification. It will also provide an opportunity to discuss
automated inspection operating considerations such as false
rejection issues and the use of two-pass inspection.
1:15 p.m. – 1:45 p.m.
The Use of Defect Sets for Automated Inspection Process
Development and Qualification
Rick Watson, Director, Sterile & Validation COE,
Merck Sharp & Dohme Corporation
1:45 p.m. – 2:45 p.m.
Q&A/Discussion
2:45 p.m. – 3:15 p.m.
Refreshment Break
3:15 p.m. – 4:45 p.m.
Afternoon Session Continued: Transition from Manual
to Automated Inspection
Moderator: Roy Cherris, Managing Partner,
Bridge Associates International
Session Description: This session continues the discussion on
best practices and challenges associated with implementation
and qualification of automated inspection equipment, in
addition to automated inspection operating considerations
such as false rejection issues and the use of two-pass inspection.
4:45 p.m.
Closing Remarks and Adjournment
John Shabushnig, PhD, Principal Consultant, Insight Pharma
Consulting, LLC, and Chair, 2016 PDA Visual Inspection Interest Group
Workshop Program Planning Committee
pda.org/2016visualworkshop
4
2016 PDA VISUAL INSPECTION INTEREST GROUP WORKSHOP – AGENDA
2016 PDA Visual Inspection Interest Group Workshop
May 18, 2016 | PDA Training and Research Institute | Bethesda, MD
2016 PDA VISUAL INSPECTION COURSE SERIES
Connecting People, Science and Regulation®
PDA EDUCATION COURSES
In conjunction with the Workshop, PDA Education will offer the 2016
Visual Inspection Course Series, which will include the popular two-day
training course, An Introduction to Visual Inspection and the Foreign
Particulate Examination, Isolation and Analysis course.
Class Schedule
All courses begin at 8:30 a.m. and end at 4:00 p.m. Please arrive at your course
location approximately 30 minutes before the start of the course to register and
receive your course materials. Please be sure to bring your confirmation letter
as proof of registration during check-in. PDA will not allow persons to attend a
course without payment, or guarantee of payment.
A continental breakfast will be served before class beginning at 8:00 a.m.
Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided
during the morning break from 10:00 – 10:15 a.m. and the afternoon break
from 2:30 – 2:45 p.m.
Students who pre-register will be given electronic course notes, which may
be printed only once, approximately 1-2 weeks in advance for use during the
course. Hard copies of course notes will no longer be provided to pre-registered
students and a limited number of hard copies will be available only for on-site
and transferring registrants on a first come, first served basis.
An Introduction to Visual Inspection
Location: PDA Training and
Research Institute | Bethesda, MD
Date: May 16-17, 2016
Duration: 2 days
Time: 8:30 a.m. – 4:00 p.m.
Course Number: PDA # 417
CPE: ACPE #0116-0000-14-064-L04-P |
1.2 CEUs
Type of Activity: Knowledge
This course covers the fundamentals of visual inspection and
their application to injectable products. It will be a combination
of lecture/discussion and hands-on laboratory exercises used to
develop and practice practical inspection skills. The skills developed
through this course may be applied to both manual human
inspection and automated machine inspection.
Who Should Attend
• Manufacturing Managers
• Engineers
and Supervisors
• Validation
• R&D Managers and Supervisors • Quality
Learning Objectives
Upon completion of this course, you will be able to:
• Identify applicable
• Use appropriate statistical
international regulatory and
tools to assess and compare
compendial requirements for
inspection methods
visual inspection
• Develop consistent validation
• Apply the critical parameters
strategies for visual inspection
which must be controlled for
processes and equipment
reproducible inspection results
Continuing Education
Faculty
John Shabushnig, PhD, Insight Pharma Consulting, LLC
Ronald Leversee, Perrigo Company
Matt Ostrowski, Pfizer, Inc.
Continuing Education for Pharmacists
Foreign Particulate Examination, Isolation and Analysis
PDA is accredited by the Accreditation Council for Pharmacy Education
(ACPE) as a provider of continuing pharmacy education. Participants
may sign up to receive Continuing Pharmacy Education (CPE) credits.
To do so, participants must sign in at the beginning of the program,
submit the provided evaluation forms and mail the CPE credit request to the address
stated on the form. Attendees must be present at the full event to receive CPE credit.
ALERT: ACPE and the National Association of Boards of Pharmacy developed the
Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically
track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past
60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon
as possible and by the deadline specified on the CPE credit request form.
Continuing Education for Professional Engineers
PDA is an approved provider by the New Jersey State Board of Professional
Engineers and Land Surveyors to offer courses to New Jersey Professional
Engineers for Continuing Professional Competency (CPC) credit. Following
the full participation in this course, participants will receive a Certificate of
Accomplishment specifying the number of CPC credits that may be awarded. This
certificate can be submitted as verification of completion to the Board for license
renewal. PDA is recognized by the North Carolina Board of Examiners for Engineers
and Surveyors as an Approved Sponsor of Continuing Professional Competency
(CPC) activities for Professional Engineers licensed by North Carolina. To receive a
Certificate of Accomplishment specifying the number of Professional Development
Hours (PDHs) that may be awarded, course participants must request the North
Carolina Board of Examiners evaluation form from PDA staff. This form must be
completed onsite at the conclusion of the course and returned to PDA staff.
Contact Stephanie Ko via email at ko@pda.org to learn more.
5
pda.org/2016visualcourses
Location: PDA Training and
Research Institute | Bethesda, MD
Date: May 19-20, 2016 Duration: 2 days
Time: 8:30 a.m. – 4:00 p.m.
Course Number: PDA # 120
CPE: ACPE #0116-0000-14-051-L04-P |
1.2 CEUs
Type of Activity: Application
This course teaches the analytical approach and methods used in
foreign particulate examination, isolation and analysis and contains
both lecture and lab time, with an emphasis on the practical
laboratory exercises. Instructors will discuss what foreign particulate
is and why it is important to identify its composition and potential
sources. Three analytical techniques will be covered – polarized light
microscopy, infrared spectroscopy and scanning electron microscopy.
Instructors will demonstrate the advantages and disadvantages of
each technique for particulate analysis and explain why using multiple
complementary techniques is often the best approach.
Who Should Attend
Pharmaceutical and medical device companies, CROs and CMOs, staff
scientists, quality control engineers, regulatory scientists, and anyone
who has the potential to deal with particulate issues in products.
Learning Objectives
Upon completion of this course, you will be able to:
• Handle and manipulate small • Evaluate different analytical
particles
methods for particle analysis
• Prepare samples for PLM, FTIR • List the tools and equipment
and SEM
needed to set up a particle
• Operate different analytical
analysis lab
tools for particle analysis
Faculty
Rich Brown, MVA Scientific Consultants
Mary Miller, MVA Scientific Consultants
Ming Zhou, MVA Scientific Consultants
2016 PDA Visual Inspection
Interest Group Workshop
Four easy ways to register –
Click: www.pda.org/2016visualworkshop
Fax: +1 (301) 986-1093 (USA)
Mail: PDA Global Headquarters
4350 East West Highway, Suite 600
Bethesda, MD 20814 USA
Call: +1 (301) 656-5900 ext 115
May 18, 2016 | Bethesda, MD
PDA Training and Research Institute
Courses: May 16-17 and May 19-20
1 Contact Information
Prefix
PDA Membership Number:
First Name
Last Name
Job Title
Company
Business Address CityState/ProvinceZIP+4/Postal Code
CountryEmail Business Phone
Fax
 Substituting for
Special Dietary Requirements (Please be specific):
(Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing
rate is due at the time of substitution. Please note that if you are a non-member substituting for a member,
you will be required to pay the difference in the non-member fee.)
Please note: In order to receive the prevailing rate, your registration(s) with payment must be
received by PDA by 5:00 p.m. ET on or before the date noted.
Check here to become a member and receive the member
price for this event. (Add $259 to your total.)
3 GSA Pricing Eligibility
On or Before
March 7, 2016
After
March 7, 2016
PDA Member
 $ 550
 $ 750
Nonmember
 $ 750
 $ 950
 $ 300
 $ 300
 $ 300
 $ 300
 PDA #417 An Introduction to Visual Inspection (May 16-17)
PDA #120 Foreign Particulate Examination Isolation and Analysis – Session 1 (May 19-20)
On or Before
April 1, 2016
 $ 300
 $ 300
 $ 280
 $ 280
 $ 280
 $ 280
After
April 1, 2016
Government/Health Authority/Academic
Member
Nonmember*
Member
Nonmember
 $ 2,350
 $ 2,595
 $ 2,350
 $ 2,595
 $ 1,500
 $ 1,600
 $ 1,500
 $ 1,600
 $ 2,595
 $ 2,895
 $ 2,595
 $ 2,895
 $ 1,500
 $ 1,600
 $ 1,500
 $ 1,500
 $ 1,600
Government/Health Authority/Academic
GSA Pricing
* For this member type or discounted rate, online registration is not available and must be faxed in.
4 Payment Options
Member
Nonmember
Member
Nonmember*
Student
Member
Nonmember*
Course #120
Standard
Academic
 $ 300
 $ 300
Course #417
Standard
Government/Health Authority
Member
Nonmember*
GS-02F-113BA
COURSE Registration | May 16-17 and May 19-20, 2016
4 Please
check appropriate fee (US$).
WORKSHOP Registration | May 18, 2016
2 Please
check appropriate fee (US$).
Member
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Are you an employee of the US Federal Government?
Yes No
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If you answered yes to both of the above questions, please select the GSA pricing in Section 4.
GS-02F-113BA
Have a Campaign Code? Print Here:
Group Registration: Register 4 people from the same organization as a group (at the same time) for the WORKSHOP
All cards are charged in US$. and receive the 5th registration free. Other discounts cannot be applied. All forms MUST be faxed in together.
By Credit Card – Clearly indicate account number, expiration date and billing address.
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CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not
received by March 19, 2016, your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you
are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form. REFUNDS:
Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Conference/Workshop: If your written request is received on or before March 19,
2016, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced
registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing
as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.
PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE
REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. REFUNDS FOR COURSES: If your written request is received by April 18, 2016, you will receive a full refund minus a $200 processing
fee. After that time, no refunds will be approved. COURSE CANCELATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled,
registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. RECORDING/PHOTO RELEASE: By
registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes.
I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape
recordings are prohibited at all PDA conferences.
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