21 CFR 820-A Roadmap to FDA Compliance

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FSMA 21 CFR 820 A Roadmap to FDA ComplianceThis 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.

Topics include:

  • Why you don’t “pass” an FDA inspection
  • The 12 of the 32 regulatory requirements which cause 80% of 483s in 2013
  • The list of 23 required procedures in the Quality System regulation
  • 3 ways to avoid Warning Letters
  • Why you need a separate glossary for your Quality System.
  • Why creating your own definitions is a bad idea…and much more

This webinar recording is only $129 (AND INCLUDES 52 – SLIDE POWERPOINT PRESENTATION):

FSMA1 21 CFR 820 A Roadmap to FDA Compliance
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.

Price: $129.00

20- Question Exam and Training Certificate available for $49.00:

exam 820 complaince 21 CFR 820 A Roadmap to FDA Compliance
EXAM – 21 CFR 820-A Roadmap to FDA Compliance

21 CFR 820-A Roadmap to FDA Compliance – EXAM

Price: $49.00

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS 21 CFR 820 A Roadmap to FDA Compliance

About Your Instructor

Rob 150x150 21 CFR 820 A Roadmap to FDA Compliance

Rob Packard is a regulatory consultant with ~25 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. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.

 

 

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