Quality Risk Management: Focused, Practical Application (E02)
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21-22 February
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Planned and Implemented by the ISPE C&Q and PM Community of Practice (COP) and PQLI
Right now the pharma industry needs quality risk management (QRM) advice that is focused, tried and proven useful, to save time, effort, and ultimately cost. Overcome reticence in applying QRM. Learn how to document it effectively within your company culture and embed it into everyone’s understanding. This highly-interactive two-day seminar will include discussions, real-life case studies, and the opportunity to practice a variety of techniques. Five years down the road from the implementation of ICH Q9, many companies have developed their systems for quality risk management, while some are still working through the process. This is an opportunity for practitioners to share experiences and swap ideas. It is also an opportunity for the less-experienced to try out some tools and techniques.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Build and implement a QRM strategy
- Understand how company culture is an inherent consideration in finding the best possible ways to incorporate QRM effectively
- Apply tools and techniques and use documentation to educate various teams and management levels to the QRM approach
- Explain how to document QRM to ensure its effectiveness
- Explain how everyone should be included in QRM planning and implementation
- Adapt QRM applications that have worked for others
Who Should Attend
The entire pharmaceutical community
Leaders
Speakers
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
This Session relates to the following Communities of Practice (COPs)
Commissioning & Qualification and Project Management