This webinar will discuss the 10 required elements of a Design Control System, as required by the US FDA’s 21 CFR 820 CGMPs and ISO 13485:2016’s 7.3. It will briefly consider current risk management requirements, and File, as they should be applied but frequently aren’t, under ISO 14971. And the new Usability Engineering / Human Factors Engineering requirements and File of IEC 62366-1,-2. It will consider different methods of implementation, and expectations of the U.S. FDA, and the EU, proven by documentation. Anticipation and addressing such on-going increased Agency and EU ISO / MDD / MDR emphasis in product design and modifications / change control proactively will further prove a company is "in control" re: the CGMPs, and EU’s QMS, and assist documenting entire medical product development process.
Why Should You Attend?
The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. ISO 13485:2016 has almost identical requirements. The company is held responsible for deciding when to start and the specific documentation to meet the 10 requirements. This 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 tools, and File, which must be a part of the design control process -- the ISO 14971 "model". And the new Usability Engineering / Human Factors Engineering requirements, and File, of IEC 62366-1,-2. 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 tool.
- FDA Device Clearance / Changes in Direction
- Current Design Control Requirements
- How to Define the "Start" Date and Its Significance
- The 10 Design Control Elements and Their Implementation and Documentation
- "Retroactive" Design Control - Not Desirable but Doable
- The Business Case for Design Control
John E. Lincoln,
J. E. Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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.
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.
- Corporate Management
- Other Consultants
- Personnel in FDA and EU MDD / MDR-regulated industries, Devices, Combination Product