How to perform effective supplier audits, and avoid FDA 483

Instructor: Dennis Moore
Product ID: 701193
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.

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 how to successfully audit and manage purchasing control areas will also be addressed.
  • Successful supplier auditing techniques.
  • How do I find GMP violations at supplier sites.
  • What constitutes a good supplier auditing process.
  • What are good auditing tools.
  • How can I answer an FDA objection related to purchase controls.
  • How do I better train supplier evaluation staff.
  • How do I know if supplier audits are adequate.

What will Students Learn:

  • Just what constitutes an adequate supplier audit
  • How do I improve my supplier audit techniques
  • What type of resource commitment is needed
  • How do I train supplier evaluation quality engineers relative to compliance issues

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
  • 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.

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