Regulatory Best-Practice Workshop

FDA Audit Preparedness

December 3, 2009  
7:30 am –  5:30 pm  
UCI University Club (Irvine, CA)

Admission: $350 Non-Member   -- $250 SoCalBio Member -- $200 Gov/Nonprofit/Academic

RSVP: https://www.123signup.com/register?id=jygfr

Workshop covers:

  • 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.

  • Managing CAPA

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

  • Supplier and vendor audit

Speakers:

  • Susan Bond, Regulatory Specialists, Inc. 

  • R. J. O'Meara, Director, Global Legislative & Government Affairs, Beckman-Coulter Inc.

  • John Clapham, President & CEO, Pharmaceutical Services Corporation

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

  • Roger Greenwald, Vice President, NJK & Associates, Inc.

  • Bob Mehta, Sr. Regulatory Compliance Manager, Edwards Lifesciences

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

  • Steve Thompson, Regulatory Consultant

Agenda:

7:30 – 8:00       Registration & Breakfast

 

8:00 – 8:10       Program Introduction 

 

8:10 – 8:55       Susan Bond, Regulatory Specialists, Inc.: Current Trends in State

                        of California Inspections

 

9:00 – 9:30      Bob Mehta, Sr. Regulatory Compliance Manager, Edwards Lifesciences:
                      Current Trends in FDA Inspection

 

9:45 – 10:30     Regina J. O'Meara, Director, Global Legislative & Government Affairs,

                       Beckman-Coulter Inc.: FDA Enforcement Priorities

 

10:45 – 11:15    Michael Swit, Vice President, The Weinberg Group Inc. :

Understanding FDA Form 483 and/or Warning Letters

 

 11:15 - 11:45    Michael Swit, Vice President, The Weinberg Group Inc. : Responding

                        to 483 Letters and Avoiding Consent Decrees 

 

12:00 – 1:00     Lunch

 

1:00 – 1:45       Julie Finke, Sr. Director, Quality Assurance Diagnostics, Novartis

                       Vaccines & Diagnostics: Hosting Regulatory Inspection and Best

                       Practices 

 

1:45 – 2:30       Roger Greenwald, Vice President, NJK & Associates, Inc. : Supplier

                        and Vendor Audit Best Practices

 

2:45 – 3:30       Steve Thompson, Regulatory Consultant: “IT Best Practices for

                        Regulatory Inspection”

 

3:45 – 4:45      John Clapham, President & CEO, Pharmaceutical Services Corporation:

                       Live Demonstration of Audit Software

 

4:45 – 5:30      Question and Answer

 

5:30                  Workshop adjourns