First Annual CAPA Congress Presentations

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DAY ONE Wednesday, Dec. 2

9:45 a.m. – 10:45 a.m.

Boehringer Ingel-heim Case Study: Process Improvement Teams Create a Strong CAPA Program
Kenneth Wexler, Senior Quality Assurance Compliance Analyst, Boehringer Ingelheim Pharmaceuticals

11:00 a.m. – 12:00 p.m.

Forest Research Institute Case Study: Integrating Pharmacovigilance Into Quality Management Systems
Boris Videlov, Director, Compliance & Quality Management, Forest Research Institute, subsidiary of Forest Laboratories

2:00 p.m. – 3:00 p.m.

Sanofi Pasteur Case Study: CAPA Investigations of Non-Conforming Product From Third-Party Suppliers
Edit Szöcs, CAPA Manager, Sanofi Pasteur

3:15 p.m. – 4:15 p.m.

Warning Letter Review: Collecting All the CAPA Puzzle Pieces – Integrating GLP and GCP Into Your GMP CAPAs
Janice Wilson, Vice President, Quality Assurance & Compliance, Elan Pharmaceuticals

DAY TWO Thursday, Dec. 3

9:15 a.m. – 10:00 a.m.

Integrating Risk Analysis and CAPA
Raymond Bonner, Partner, Sidley Austin LLP

10:00 a.m. – 10:45 a.m.

CAPA and Trend Analysis: How to Organize “Chaos”
Elizabeth Troll, Principle, Troll Advisory Group LLC