Topics You Need to Know 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
- Critical components of Management Responsibility 820.20
- When to start a Design History File
- When does design transfer take place?
- Purchasing controls 820.50
- Where FDA is focusing their inspection efforts in this area
- Production and Process Controls
- Why your internal auditors should be spending time on your production floor
- The #1 weakness in production process controls
- How to proceed with validation if you move a piece of equipment 5 feet?
- Nonconforming product-820.90
- FDA hot button-where all your dirty laundry is located.
- FDA focus-how is your company controlling its nonconforming product?
- Disposition of rework and “as is” product-importance of procedures
- How you fix all of your problems
- If you don’t know how to do a root cause analysis 5 different ways, you need training
- Device labeling-FDA looks for labeling mixups or potential labeling mixups
- Storage 820.50-why you need records of transactions and approvals
- Device Master Record
- Master formula of how your make your product.
- How to utilize effectively to appease an FDA inspector-and show how you’re in control of your documentation
- Medical Device Reporting-Part 803
- August 14, 2015-final rule becomes effective
- QS Record-820.186 documents that are not included in the Device Master Record
- Complaint files 820.198-
- In depth discussion of complaint investigation record requirements
- What 6 things service reports must contain
- How to keep current with new FDA guidance documents
20- Question Exam and Training Certificate available for $49.00:
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.