Success - Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device Inspection

download Success   Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device Inspection

qsit and 820 Success   Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device Inspection

 

FSMA Success   Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device InspectionThis 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 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
  • CAPA
    • 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
This webinar recording is only $129 (AND INCLUDES 52 – SLIDE POWERPOINT PRESENTATION):

%name Success   Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device Inspection

 

 

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

%name Success   Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device Inspection

 

About Your Instructor

Medical Device Academy Robert Packard Success   Here is your Complimentary Webinar: How to Prepare for an FDA Medical Device InspectionRobert 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.