Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries"

This webinar will discuss the 10 required elements of a Design Control System.


The FDA CGMPs (21 CFR 820.30) and ISO QMS’ (ISO 13485:2016 7.3) expect companies to perform meaningful, results driven Design Control activities as defined in the regulations / standards, for both new and changed devices.  The company is held fully responsible for deciding when to start and the specific documentation (DHF, D&DF …) to meet the 10 requirements.  Beyond compliance, these 10 elements can be a powerful tool in reducing "time to market" / "fast cycle" product development.  In addition, growing high-profile field problems indicate that design control and it’s effect on regulatory review activities are not yet fully utilizing the power of current risk management and use / human factors tools, which must be a part of the design control process -- the ISO 14971 amd IEC 62366-1 "models".  A growing push by the Agency to strengthen the 510(k) process, and review existing devices with above normal adverse events are additional concerns, to be factored into the design control process.  The resulting documentation can have other far-reaching uses in a company.  Proper design control requires a defined "start" date, and the systematic / SOP-defined implementation of formal methods with documented, and defensible, rationale.  When properly executed, it is a powerful product development project management, training, compliance and IP tool.

Why should you attend

This webinar will discuss the 10 required elements of a Design Control System.  It will consider different methods of implementation, and expectations of both the U.S. FDA and EU, proven by documentation. Such an analysis takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the safety, usability, and efficacy of medical devices.  Anticipation and addressing such on-going increased Agency / EU emphasis in product design and modifications / change control proactively will further prove a company is "in control" re: the CGMPs and ISO QMS, and assist documenting the entire medical product development process, assisting IP, failure investigations, root cause analysis, and provide templates for future product development.

Areas Covered

•      Current Design Control Requirements – FDA and EU
•      Defining the "Start" Date, When and How, and Its Significance
•      The  10 “Must Have” Design Control Elements
•      Implementation / Documentation 
•      "Retroactive" Design Control
•      Integrating ISO 14971 and IEC 62366-1 and their Roles in the Design Control Process
•      The Business (C-Suite) Case for Design Control

Who will Benefit

•     Senior management 
•     R&D
•     Engineering
•     Software engineers
•     Manufacturing / Operations
•     Marketing
•     Purchasing
•     Consultants
•     All others tasked with product development, acquisition and production

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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, he 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 is a graduate of UCLA.

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