Pharmaceutical Inspections and Compliance - Current FDA Enforcement Trends (E07)

23-24 February
CEUs: 1.2

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

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

Communities of Practice (COP)

C&Q, GAMP, Good Control Laboratory Practices, PAT