Pharmaceutical Inspections and Compliance - Current FDA Enforcement Trends (E07)
The FDA's Process Validation Guide recently released changes the definition of Validation.
Are you equipped to respond to it?
Did you know that:
- In the future Validation should be a product life cycle approach that starts with Process Design, and spans Process Qualification and Continued Process Verification.
- Continued Process Verification is applicable to both new and legacy products, the Agency is looking for continual assurance that the process remains in a state of control, and there are new expectations for statistical reviews.
Join subject matter experts from industry and the FDA's Grace McNally for an interactive discussion to learn exactly what these changes mean to you. This first face-to-face opportunity since the Guide’s release can help you eliminate costly errors and avoid unwanted and wasted effort. Can you afford to miss this event?
This two-day seminar will bring together FDA and industry experts to address:
- Current inspection findings
- FDA expectations for GMP and quality systems
- The quality of the supply chain by adequate qualification of vendors and contract manufacturers
- Current expectations around management responsibility
- CDER’s Part 11 inspectional assignments
New GMP initiatives include:
- Q10 and process validation
- Continuous manufacturing including PAT
- Identifying leading problem indicators and examples of successful solutions with respect to a Quality Systems (QS) approach
- Proactive QS elements (rather than defensive ones) in GMP and Quality Systems
- Examples from Q8, Q9, and Q10.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Analyze your company’s current readiness for FDA inspections in light of very recent indicators and current inspection findings
- Understand current findings as to the role and responsibility of senior management
- Understand your company’s compliance risk and address it proactively
- Apply solutions from other company’s successful approaches
- Better understand CDER’s next steps in continuing its Part 11 assessment
Who Should Attend
Manufacturing, Development, Engineering, Laboratory, Regulatory, Quality, IT
- 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
Communities of Practice (COP)
C&Q, GAMP, Good Control Laboratory Practices, PAT
Related Guidance Documents, Articles, and Publications
- Part 11
- Guidance documents such as Q8, 9, 10, and Process Validate Guidance Document Draft
Visit www.ISPE.org/Publications for more information