'Performing effective supplier audits: a coming FDA compliance focus'

Many firms feel that they are adequately auditing and managing suppliers, yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on supplier auditing compliance in 2007-2008. With this focus, FDA is going to heavily write firms up for purchase controls GMP violations. Repeated FDA 483’s can lead to warning letters, seizures or even jail time. This presentation will cover auditing and management techniques in relation to purchasing control compliance. Real supplier auditing processes and other management tools associated with purchasing controls will be discussed. Actual FDA investigator auditing techniques will also be addressed in the talk.

Areas Covered in the seminar:
Performing effective supplier audits: a coming FDA compliance focus will be addressed. Elements of of how to successfully audit and manage purchasing control areas will also be addressed

• Successful supplier auditing techniques
• Key elements of 21 CFR 820.50
• What constitutes a good auditing process
• What are good supplier auditing tools
• How can I answer an FDA objection related to purchasing controls
• How do I better train supplier auditors?
• How do I know if supplier audits are adequate

What will students Learn:

• Just what constitutes an adequate supplier audit and what elements of 21 CFR 820.50 are involved
• How do I improve my supplier auditing techniques
• what type of resource commitment is needed
• how do I better to train quality auditors

Who will benefit:
This webinar will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations. The talk will cover all types of supplier audits, including contract manufacturers The webinar will help you avoid FDA 483’s and warning letters. The employees who will benefit include

• Regulatory Managers
• RA/QA Managers and employees
• Government Auditors
• Quality System Auditors
• Industry Consultants

Instructor Profile
Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.