US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

Why Should You Attend:

In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. What is the importance, and purpose, and the framework of basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 15 subparts, terms, and the underlying purpose for the requirements under the Device CGMPs? How is a company’s quality management system “established / implemented and maintained under this Quality Management System (QMS)? Major discussion points: Regulatory requirements that apply to the methods, facilities and controls used for device design and development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement.

Areas Covered in the Webinar:

• What are US FDA expectations for a compliant device QSR?
• How can a company develop and maintain a dual QMS.
• Basic Systems / SOPs.
• QSIT (FDA’s Quality System Inspection Technique)
• Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.
• Current areas of FDA concern.
• Other US FDA device requirements.
• Maintaining compliance under increasing regulatory expectations.
• Similarities /differences to ISO 13485 and the MDR.

Who Will Benefit:

• R&D
• Engineers
• Software developers
• QA / RA
• Marketing
• Manufacturing
• Operations
• Staff
• Middle Management
• Senior Management

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 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time 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 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, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

Frequently Asked Questions:

1. Now that EU MDR is effective, Do we expect FDA to shift from 21CFR4 to require combo products to meet all elements of 21CFR820 or ISO13485?

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