Regulatory Best-Practice Workshop

FDA Audit Preparedness

June 12, 2009  
7:30 am –  5:30 pm  

Los Angeles Chamber of Commerce
350 S. Bixel Street, Los Angeles, CA 90017

Workshop covered:

• The latest compliance trends in recent FDA and State of California inspections from device, pharma and IVD experts.  

• 483 responses, warning letter responses and Consent Decrees and how to avoid them.  

• Best practices in hosting regulatory inspections and best practices for self inspection.

Presentations Available:

• CA Inspections:

  • James Barquest, Ph.D., Director of Regulatory Affairs, Ground Zero Pharmaceuticals

• FDA Inspection Trends: Auditing CMOs:

  • E. J. Brandreth, Vice President, Althea Technologies

• FDA Inspection Trends: Computerized Systems:

  • Jacques Mourrain, Ph.D., Director of Corporate Compliance at Genentech

• Hosting Inspection Best Practices:

  • Julie Finke, Sr. Director, Quality Assurance Diagnostics, Novartis Vaccines & Diagnostics 

• Auditing Vendors:

  • Ruchika Raval, President, Global BioPharm Regulations

• Enforcement and 483 Letters:

  • Michael Swit, Vice President, The Weinberg Group Inc.

• Enforcement and Consent Decrees:

  • Karen A. Weaver, JD, RPh, Attorney, Baker & Hostetler

Agenda:

7:30 – 8:30       Registration & Breakfast

8:30 – 8:45       Program Introduction by Ahmed A. Enany, President & CEO, Southern California Biomedical Council (SoCalBio)

8:45 – 9:30       Current Trends in State of California Inspections by James Barquest, Ph.D., Director of Regulatory Affairs, Ground Zero Pharmaceuticals  

9:30 – 10:00     Question and Answers

10:00 – 10:15   Coffee Break

10:15 – 11:15   Current Trends in FDA Inspections by E. J. Brandreth, Vice President, Althea Technologies and Jacques Mourrain, Ph.D., Director of Corporate Compliance at Genentech Inc.

11:15 - 11:30   Question and Answers

11:30 – 12:00   Understanding FDA Form 483 and/or Warning Letters by Michael Swit, Vice President, The Weinberg Group Inc.  

12:00 – 1:00     Lunch

1:00 – 2:15       Responding to 483 Letters and Avoiding Consent Decrees by Karen A. Weaver, JD, RPh, Baker & Hostetler  

2:15 – 2:30       Coffee Break

2:30 – 3:15       Hosting Regulatory Inspection and Best Practices by Julie Finke, Sr. Director, Quality Assurance Diagnostics, Novartis Vaccines & Diagnostics 

3:15 – 3:30       Question and Answer

3:30 – 4:30       Supplier and Vendor Audit Best Practices by Ruchika Raval, President, Global BioPharm Regulations and John Clapham, President & CEO, Pharmaceutical Services Corporation

4:30 – 5:30       Question and Answer