Read Frequently Asked Questions
How to perform effective supplier audits, and avoid FDA 483
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
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.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.
We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email firstname.lastname@example.org or call +1-888-717-2436(Toll Free).
This training hasn't been reviewed yet.
What will FDA expect and request from your firm during Design Control portions of Inspections? Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters Effective Hazard Analysis and Design Control for FDA and ISO 13485 Compliance: Pack of Two Courses