Internal and Supplier Auditing in a Global Quality System

Brought to you by Compliance-Alliance and co-sponsored by The University of Southern California, Underwriters Laboratories, Emergo Group, FOI Services and Merrill Brink International

Internal and Supplier Auditing in a Global Quality System

The Westin Las Vegas
Tuesday-Wednesday, March 10-11, 2009

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Faculty:

• Al Taylor, FDA's CDRH
• Denise Dion, Eduquest, formerly of FDA's Office of Regulatory Affairs
• Cheryl Johnson, Sr Manager, International Quality, Boston Scientific
• Jaap Laufer, PhD, VP Public & Regulatory Affairs, Emergo Group Inc.
• Bonnie Norman, Director RA/QA, Intel Digital Health
• Kris Ann Bolt, QA Supervisor, Harmac Medical Products
• Virginia Perry, Partner, Perry-D'Amico & Associates
• Keisuke Kaye Suzuki, Principal, Kaye Suzuki Device Consulting, LLC, former Director for Guidant Japan K.K.
• Frances Richmond, Ph.D, Director Regulatory Science Program, USC School of Pharmacy
• Tara Kambeitz, Global Marketing Manager, UL
• Emi Zychlinsky, PhD, VP, R & D, Hitachi Chemical Diagnostics
• C. Seiko Ohyama, RCB Lead Auditor for PAL 3rd Party Certification, UL Japan Inc.
• William I. White, Ph. D, Quality System Strategies LLC, former Manager, Quality System Strategy, Bayer HealthCare LLC
• Nancy Singer, President, Compliance-Alliance

Agenda:

Tuesday March 10, 2009

1:15 - 1:30   Registration

1:30 - 1:40   Welcome

• Frances Richmond, Ph.D, Director Regulatory Science Program, USC School of Pharmacy
• Tara Kambeitz, Global Marketing Manager, UL
• Nancy Singer, Compliance-Alliance

FDA’s Expectations for Device Firms with International Facilities
– Al Taylor, FDA's CDRH
- Denise Dion, Eduquest, formerly of FDA's Office of Regulatory Affairs

• How FDA selects the firms to inspect
• Do’s and don’ts for interacting with investigators
• The most common challenges

Conducting Internal Audits in International Facilities
- Cheryl Johnson, Senior Manager, International Quality, Boston Scientific

• Steps to take to prepare for an internal audit
• Who should be on the audit team
• Key characteristics of an effective auditor
• How to overcome differences in language
• How to present observations and respect culture differences

After the Audit
- William I. White, Ph. D, Quality System Strategies LLC, former Manager, Quality System Strategy, Bayer HealthCare LLC

• What to do about different types of deficiencies
• How to establish a time frame for corrective action
• What to do when people refuse to pursue corrective action
• How to get buy-in for the program
• What if FDA or Notified Body findings don't agree with internal audit findings?
• Assessing the effectiveness of the program

5:00 – 6:00   Reception


Wednesday: March 11, 2009

8:00 – 8:30   Continental Breakfast

8:30 – 8:40   Announcements

Similarities and Differences in Handling an FDA Inspection Versus a Notified Body Audit
 – Bonnie Norman, Director RA/QA, Intel Digital Health

• Designing different SOPs for FDA investigations and Notified Body audits
• Different approaches to conflict resolution
• When to involve management to resolve controversies

An Auditor's Perspective on Multi-site Audits Under the Pharmaceutical Affairs Law in Japan
– C. Seiko Ohyama, RCB Lead Auditor for PAL 3rd Party Certification, UL Japan Inc.

• Protocol for the inspections
• Keys to making a good impression on the auditor
• Common mistakes to avoid

The Company Perspective on a Quality System Audit by the Pharmaceutical Medical Device Agency in Japan
 - Keisuke Suzuki, Former Director for Guidant Japan K.K.

• Key elements for how to prepare for a PMDA inspection
• Mistakes to avoid during the inspection
• Best practices for corrective action after the inspection

12:00 – 1:00   Lunch

Exercise: Avoiding Common Mistakes With Internal Audits, FDA Inspections and Notified Body Audits
- Virginia Perry, Perry-D’Amico and Associates
- Denise Dion, Eduquest
- Kris Ann Bolt, Quality Assurance Supervisor, Harmac Medical Products

GHTF Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers
- Emi Zychlinsky, PhD. Vice President, Research and Development Hitachi Chemical Diagnostics

• Key elements of the guidance
• How firms are using the guidance to audit their suppliers
• Overcoming the challenges

Coordinating Quality Compliance for Multiple International Locations and Suppliers
- Jaap Laufer, PhD, VP Public & Regulatory Affairs, Emergo Group Inc.

• Harmonizing QMS systems for multiple locations
• Dealing with a newly acquired division or a new facility
• Defining critical versus non critical suppliers and how to properly audit/control them

How to Use Risk Management Principles to Prioritize Your Audit Activities
- Denise Dion, Eduquest, formerly with FDA Office of Regulatory Affairs

• Criteria to evaluate your suppliers based on risk
• How to deal with an unresponsive sole source supplier
• Justifying that criteria during an inspection or audit

5:00   Adjournment

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