US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes


Instructor: John E Lincoln
Product ID: 706950
Training Level: Basic to Intermediate

  • Duration: 90 Min
The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).
Last Recorded Date: Feb-2024


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This webinar will examine the 15 sub parts of the Medical Device CGMPs, 21 CFR 820, the Quality System Regulation, compared against the current version of ISO 13485:2016, with its 8 "sub parts". The substantial areas of similarities will be discusses; then the areas of FDA concern and proposed solutions; and the adding in those requirements necessary to remain in alignment with the US FDA's Federal Food, Drug & Cosmetic Act.

The structure of the proposed QMSR will be discussed: 820.1 Scope; 820.3 Definitions; 820.7 Incorporation (ISO 13485:2016) by reference; 820.10 Requirements for a quality management system - Links additional FDA requirements such as MDR, UDI, Corrections & Removals, and Tracking; applicability of Design and Development activities; 820.15 Clarification of concepts - Correlates concepts in ISO 13485 to FDA; 820.35 Control of records - Supplements record keeping activities, signature and date, complaint / servicing records, UDI, and confidentiality; and 820.45 Device labeling and packaging controls. The primary areas of differences: Document Control, Labeling and Packaging Control, Records, and Servicing. These will be discussed in the webinar as well. There will be a one-year transition period.

Why Should You Attend:

FDA/CDRH is proposing to harmonize the current Quality System (QS) regulation for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. Revisions to Part 820 will replace most of the existing regulation with an incorporation by reference (IBR) to the 2016 edition of" ISO 13485 - Medical Devices - Quality Management Systems Requirements for Regulatory Purposes". The requirements in ISO 13485:2016 are substantially similar to the current requirements of Part 820, the QSR. Differences will be explained or reconciled, and the few areas where ISO 13485 is considered weak by the FDA will be strengthened in the proposed US QMSR.

Areas Covered in the Webinar:

  • The New QMSR replaces the Old QSR.
  • The Structure of the QMSR

  • Key Similarities
  • Key Differences
  • "Incorporate By Reference"
  • Increased Emphasis on Patient Risk Management

  • Terminology Changes
  • FDA retains Inspectional Authority - Not Yet Harmonized

Who Will Benefit:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel involved in the U.S. FDA-regulated medical device spec development, and manufacturing environments. Especially those involved in new medical device / combination product development, line extensions, and incremental product improvements; CGMP compliance, and the documentation of these actions in harmony with the regulations.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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