Document 6514354

HOW TO WRITE SOPs - 7 July 2014
IMPROVING PROCESSES & CAPA - 8 July 2014
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An Essential Course for Ensuring Compliance with
Regulatory Requirements
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How to Write SOPs – 7 July 2014
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Improving Processes & CAPA – 8 July 2014
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How to Write Concise and User Friendly SOPs
How to Prepare the Topic Content of SOPs
Implement and Manage SOPs Effectively
Effective SOP Training
Ensure your SOPs Incorporate Appropriate Regulatory Requirements
Dr Laura Brown, Independent Pharmaceutical QA Consultant, the Course
Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff
and Course Director, MSc Regulatory Affairs, TOPRA.
Opposite V&A Museum. Nearest underground station:
South Kensington.
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Discounted Rates
Available on application for personnel from non-profit
making organisations and registered charities.
Group discount available on request
Topics to be covered include:
With
Directions
7 July 2014 - The Rembrandt Hotel, London
*The fee includes course documentation as well as
mid-session refreshments and lunch. Invoice and confirmation
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HOW TO WRITE SOPs
W
JOIN US ON
IMPROVING PROCESSES
AND CAPA (CORRECTIVE
AND PREVENTATIVE ACTION)
Topics to be covered include:
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Understand CAPA Methodology and Documentation
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Learn Tools and Techniques to Help Make your Existing Processes more Efficient and Compliant
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Discover how you can Address Inspection Findings using CAPA
and Process Improvement
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How to Develop Options for Process Improvement and CAPA
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Planning and Implementation in Practice of Improvements and CAPA
With
Dr Laura Brown, Independent Pharmaceutical QA Consultant and the
Course Director for the MSc Clinical Research, School of Pharmacy, University of
Cardiff
8 July 2014 - The Rembrandt Hotel, London
HOW TO WRITE SOPs
INTRODUCTION
7 July 2014
SOPs play a crucial role in compliance with
regulations. It is therefore essential that they are
well written and easy to use by the end-users. If
SOPs are not followed correctly, the validity of data
generated is compromised, leading to inspection
findings and non compliance issues which could
lead to delays in bringing a drug/device to market.
This SOP course has been specifically designed
to help you develop the skills to write, produce the
content of SOPs, review and implement SOPs and
in particular to be able to comply in a regulated
environment. It is essential therefore to have a
number of SOPs, and for existing SOPs to be
reviewed and updated regularly. Otherwise this
is likely to result in major findings by regulatory
inspectors. Participants will come away with the
confidence to use a process to write, update and
implement SOPs which can easily be used by the
end users.
WHO SHOULD ATTEND
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All those in Pharma, Biotechnology, Devices
and Veterinary industries who will be or are
involved in preparing, reviewing and/or managing SOPs
Ideal as an introduction to preparing, reviewing
and implementing SOPs and may also be helpful to those wanting to ensure they are aware
of best practice
Particularly those in GXP areas including clinical research, pharmacovigilance, regulatory
affairs and GMP
u Introduction and Objectives
uHow to Write Concise and User Friendly SOPs
• When are SOPs needed and why?
• What is the difference between having SOPs and work instructions/local
guidance?
• Format, content, style and presentation
• Translation of the activities into the SOPs
• Writing sufficiently detailed SOPs, but which are not restrictive
• Defining SOP content using mind mapping and flow charting
•
Review and approval processes for SOPs
8 July 2014
COURSE LEADER
INTRODUCTION
COURSE LEADER
Dr Laura Brown is an Independent Pharmaceutical
QA and training Consultant and the Course Director
for the MSc Clinical Research, School of Pharmacy,
University of Cardiff. Laura is a recognised expert in
QA and training. She has more than 19 years
experience in the pharmaceutical industry in a
number of senior roles and has worked for several
companies, including GlaxoWellcome, Hoechst
Marion Roussel, Farmitalia and Phoenix
International. She has worked in several Quality
Assurance roles which have included writing and
reviewing SOPs and has helped companies
implement the regulatory requirements of changes
in regulations.
In today’s highly regulated Pharma, Device and
Veterinary industries, it is essential to use the most
efficient processes and ensure compliance with
Corrective and Preventative Action (CAPA).
Regulatory Inspectors are increasing reviewing
responses to findings dealt with by the CAPA
approach and process improvement.
Dr Laura Brown is an Independent Pharmaceutical
QA and training Consultant and the Course
Director for the MSc Clinical Research, School of
Pharmacy, University of Cardiff.
IN-HOUSE COURSE
This seminar is also available as an in-house
course, and can if required be tailored to your
specific needs. For further information please
contact Sarah Spanswick –
sarah@management-forum.co.uk
Certificates of Attendance for
Professional Development will be given to
each participant who completes
these seminars
Register on-line at
www.management-forum.co.uk
or telephone +44 (0) 1483 730071
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It is highly likely that the organisations who have
already been inspected will be assessed at next
inspection in terms of whether the corrective and
preventative actions have been implemented – has
the organisation done what they said they would?
If previous major findings have not been addressed
then a critical finding may be given.
This course will be ideal for you to learn how to
improve industry procedures and processes and
how to implement and document an effective
CAPA quality system.
WHO SHOULD ATTEND
The course has been specifically designed for
the Pharma, Biotechnology, Devices and
Veterinary industries and particularly if you are
involved in process improvement, corrective and
preventative action, problem solving and
managing inspections and documenting how to
deal with these.
Laura is a recognised expert in QA and training.
She has more than 19 years’ experience in the
pharmaceutical industry in a number of senior roles
and has worked for several companies, including
GlaxoWellcome, Hoechst Marion Roussel,
Farmitalia and Phoenix International.
IN-HOUSE COURSE
This seminar is also available as an in-house
course, and can if required be tailored to your
specific needs. For further information please
contact Sarah Spanswick –
sarah@management-forum.co.uk
Certificates of Attendance for
Professional Development will be given to
each participant who completes
these seminars
Register on-line at
www.management-forum.co.uk
or telephone +44 (0) 1483 730071
PROGRAMME
PROGRAMME
uSOP Implementation and
Management
IMPROVING PROCESSES & CAPA
Handling updates – when should SOPs be updated and how?
Distribution, version control
SOP training
How to maximise end user compliance
Tips for what auditors and inspectors look for when they review SOPs
u Ensuring your SOPs include
Appropriate Regulatory
Requirements and Objectives
• What level of regulatory requirements should be in SOPs?
• What topics should the SOPs cover?
• What needs to be included for compliance? - GxP areas including clinical research, pharmacovigilance, regulatory affairs and GMP
uFinal Questions and Close
u Introduction and Objectives
u Developing Options for Process
Improvement and CAPA
uCAPA Methodology and Documentation • Identification – clearly define the problem
• Evaluation – appraise the magnitude and
impact, e.g. scenarios, test out assumptions (e.g. using the Uncertainty – Importance grid to help identify potential risks)
• Investigation
• Analysis – perform a thorough assessment – review data, prioritise, develop options for solutions
• Action Plan – create a list of required tasks
• Implementation – execute the action plan, e.g. stakeholder analysis, the transition curve
• Follow Up – verify and assess the effectiveness of the CAPA
• Finding(s)
uDiagnosing Process Improvement
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Using problem diagnosis (for example, “root cause” analysis) for understanding why processes are cumbersome and to help facilitate resolving audit and inspection findings
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Being more creative in problem solving of
process simplification issues
Evaluation of the attractiveness/likely
difficulty of changes (“AID” analysis)
Continuous improvement teams – as an
invaluable approach for improving the
implementation of regulatory change
uPlanning and Implementation in
Practice of Improvements and CAPA
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Project managing process improvements and CAPA
Managing the change and people issues
Managing the stakeholders involved (stakeholder analysis)
uFinal Questions and Close