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RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.


What are U.S. FDA CGMP requirements for the manufacture of medical devices ffor sale in the US. Discuss the key Quality System Regulation / Quality Management System requirements of 21 CFR 820, the Quality System Regulation.

This webinar will examine the 14 key elements of the Medical Device CGMPs, 21 CFR 820, the Quality System Regulation, the 7 key elements, and the defining 4 elements, as defined and evaluated by the FDA's QSIT. Product development and manufacturing ("realization") and its compliance and documentation.Design Control, the Device History File, the Device Master Record and the Device History Record are defined. Corrective and Preventive Action (CAPA) requirements and key components. Production and Process Control (P&PC) expectations. Verification and Validation, including software - Why and How? Differing approaches to compiance inspectioins / audits internallyby the company and externally by the FDA. 

Why Should You Attend

Global companies must meet US FDA 21 CFR 820 (The QSR) requirements in order to sell such devices in the US, no matter where they are manufactured . These companies must pass FDA compliance inspections (audits) to 21 CFR 820.  The cGMPs mandate 15 key systems and procedures that must be followed and documented to allow cleared / approved product to be sold commercially in the US. Of those 15, the FDA focuses on 7, and places extreme emphasis on 4, per QSIT. Why? What does compliance look like? What are the benefits to the company for compliance? What role does the Risk Management File (ISO 14971) and Use Engineering File (IEC 62366-1) play in conformance and day-to-day compliancet. How does failure to comply result in adulterated product, 483 Observations, Warning Letters, and worse.  What are key components of a CGMP-compliant QMS, a Risk Mangement File, and a Use Engineering / Human Factors File, and their interrelationships.

Webinar Takeaway

  • The U.S. FDA's 21 CFR 820, the QSR, the Device CGMPs / QMS, QSIT
  • The Documentation Requirements
  • Design Contol; Risk Management, and Human Factors / Use Engineering
  • Management Responsibility 
  • Production and Process Controls
  • CAPA
  • DHF Required Contents
  • The Risk Management File (ISO 14971) and its role
  • The Use Engineering File (IEC 62366-1) and its role
  •  Expected QMS Records
  • The DMR and DHR
  • FDA Inspectioin / Audit Focus

Who will Benefit

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • 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; having to evaluate those changes in light of the DHF / CGMPs, and then document these actions in harmony with the regulations.

Faculty John E Lincoln

Faculty John E. Lincoln

Principal of J. E. Lincoln and Associates LLC

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.


RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria