Rob Packard of Medical Device Academy provides 7 proven steps to effectively respond to an FDA 483. Included are examples, recommendations and tips; for implementing the 7 steps including:
- Respond within 15 business days
- Use your CAPA form
- How to document a root cause investigation
- Don’t forget correction and containment
- Corrective action plans
- Show you have already taken action
- Follow up before the FDA
Other topics reviewed include:
- 8 D Process-“8 Disciplines” to be utilized as a model for an effective CAPA process
- Recalls
- Documentation
- Effectiveness checks (examples)
- Trend analysis
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES): Exam and Training Certificate available for $49.00:
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About Your Instructor
Robert 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. Robert 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. Robert’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. You can also follow him on Google+, LinkedIn or Twitter.