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Dr. David Lim



Quality System Regulations (QSRs) for Medical Devices and IVDs

Product Id : MD1351       Category : Medical Devices

60 Minutes

Description :

FDA states in warning letters “This inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…”. This webinar will address the said current good manufacturing practice (cGMP) requirements to help you stay in conformity with 21 CFR Part 820 (QSR).

Accurate understanding and interpretation of cGMP requirements found at 21 CFR Part 820 can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.

This webinar is intended to help you get familiar with FDA’s Quality System Regulations (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the best practices for implementing 21 CFR Part 820 (QSRs), which helps assure that medical devices are safe and effective for their intended use.

This 60-min webinar will help you ensure if you engage in the best practices for establishing and maintaining quality management systems necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMPs).
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Areas Covered in the Session :
  • Applicable Laws
  • FDA Quality System Regulations
  • Definitions
  • Design Control: Design And Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design Changes
  • Design History File (DHF)
  • Quality System Procedures, Purchasing Controls And Servicing
  • Inspection, Measuring And Test Equipment
  • Process Validation
  • Corrective And Preventive Action (CAPA) And Complaint Files
  • Quality Requirements For Premarket Approval (PMA) Application
  • Device History Record (DHR) And Device Master Record (DMR)
  • Mistakes While Implementing QSRs
  • How to Avoid Mistakes
  • Frequent Citations in 483s and How to Avoid
  • Top 20 Items Cited in 483s
  • Lessons Learned:  Best Practices
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Who Will Benefit:
  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • R&D and Manufacturing Managers
  • Managers (RA, QA/QC, CA)
  • Consultants
  • Contractors and Subcontractors
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For Live – How it works:
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Q&A session with the Speaker
  • Feedback form
  • Certificate of Attendance
For Recording – What you will receive:
  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months)
  • Presentation Handout in .pdf format
  • Recorded session of the presentation from the Speaker
  • Feedback form
  • Certificate of Attendance (optional)
Speaker Profile
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA's transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.
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