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 Management File, and a Use Engineering / Human Factors File, and their interrelationships?Course Content
DAY 1Session 1
- The U.S. FDA's 21 CFR 820, the QSR, the Device cGMPs/QMS, QSIT
- The Documentation Requirements
- Design Controls
- Management Responsibility
- Production and Process Controls
- Corrective and Preventive Action (CAPA)
- Materials Control
- Facilities and Equipment Control
Session 1
- DHF Required Contents
- Verification and Validation, including software - Why and How?
- 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 Inspection/Audit Focus
- New QMSR rule changes to 21 CFR 820 and ISO 13485
Speaker
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.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, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
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
- Those evaluating changes in light of the DHF / cGMPs and documenting actions in harmony with the regulations
