The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers

What are U.S. FDA cGMP requirements for the manufacture of medical devices for sale in the US? Discuss the key Quality System Regulation / Quality Management System requirements of 21 CFR 820, the Quality System Regulation. QSIT for FDA inspections. And anticipated changes to a QMSR.

This 2-day seminar 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? Risk management under ISO 14971, a major component of the proposed QMSR, will also be considered. Differing approaches to compliance inspections / audits internally by the company  and externally by the FDA. A discussion of FDA's new proposed revised 820 incorporating ISO 13485, into the new QMSR, will also be included.

WHY YOU SHOULD 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 compliance.  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 Managements File, and a Use Engineering / Human Factors File, and their interrelationships.

WHO SHOULD ATTEND:

• Senior Management
• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• 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.  

AGENDA

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 28 of which 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 FDA-compliant new product development and to market issues, quality assurance, regulatory affairs, QMS problem remediation and FDA responses, 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 VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters in peer reviewed publications (5 chapters in RAPS textbook on V&V) conducted workshops and webinars worldwide on virtually all cGMP issues. John is a graduate of UCLA.