This free one-hour webinar provides a basic overview of how to prepare for an FDA medical device inspection.
FDA Inspection Webinar Topics include:
- FDA’s approach to conducting inspections
- How FDA prioritizes their inspections
- QSIT approach-7 major and minor sub systems
- Types of FDA inspections
- Management review, internal audits, supplier audits – Which documents FDA may request
- “Back room” preparations for organizing the inspection
- FDA 483s – Wording, Most common 483s in 2013
Includes Native Slide Deck for FDA Inspection Webinar
* Please note-first 5 minutes-audio only
FIND OUT EVEN MORE WITH OUR NEW WEBINAR ON DEMAND – 21 CFR 820 – A Roadmap To FDA Compliance
This 90+minute webinar recording, 21 CFR 820-A Roadmap to FDA Compliance, is a must have “insider’s guide” of tips, examples and advice for specific areas where FDA inspectors will focus their inspection efforts related to the 31 sections of the 21 CFR Part 820 Quality System regulation. Click Here For More Information
About Your Instructor
Rob Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering and Strategy. He can be reached via phone 802.258.1881 or email.
This free one-hour webinar provides a basic overview of how to prepare for an FDA medical device inspection.
FDA Inspection Webinar Topics include:
- FDA’s approach to conducting inspections
- How FDA prioritizes their inspections
- QSIT approach-7 major and minor sub systems
- Types of FDA inspections
- Management review, internal audits, supplier audits – Which documents FDA may request
- “Back room” preparations for organizing the inspection
- FDA 483s – Wording, Most common 483s in 2013
Includes Native Slide Deck for FDA Inspection Webinar
* Please note-first 5 minutes-audio only
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