Overview
Combination products are subject to a combination of CGMPs to form an "Operating System". This greatly increases compliance to the Combo Products CFMPs, 21 CFR 4. And recent problems have compounded supply chain issues.
There has been a major shift in the emphasis of U.S. FDA requirements for drug, device and combination product development. The FDA has implemented major global initiatives. Companies are required to tightly manage risk traceable to the patient / end user throughout their entire supply chain. AI can be involved in product development, as well as post-development issues. Such changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency is also reacting to notable recent product shortages, leading to public concern over insufficient oversight of the entire medical product supply chain, including global outsourcing. Combination products add further complexity. All this is affecting the Agency's approach to inspectional / audits and their expectations for companies. The entire development process and the involvement / framework of AI in it will be discussed in this webinar.
Why Should You Attend
Product development increasingly involves some element of AI. The FDA is addressing this by developing frameworks / guidance to address product development in these industries. In addition, increasing globalization of supply chains have increased risks to patients / end users. All this is further affecting the development of drugs, devices, and especially combination products. Ultimate CGMP compliance and risk management cannot be passed on to suppliers. All mut do their part but ultimate responsibility rests with the final manufacturer. Combination products only serve to compound the problems. Avail you company of this new direction by the FDA and the CGMPs - the law - with the new insights provided by this webinar.
Webinar Takeaway
- AI and drug, device and combination product development
- Combination products and added supplier complexity
- The CGMP "Operating System"
- Supplier Trending and Ranking Models
- Mandated Supplier Controls; Change Controls
- COAs / COCs
- The Globalization of the Supply Chain and What That Means
Who Will Benefit
This webinar will provide valuable assistance to all regulated companies in evaluating their existing product development, including AI and supply chain control / compliance, and the FDA's and CGMP requirements and enforcement. Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceutical, Biologics and Combination products fields. The employees who will benefit include:
- Senior management
- R&D
- Regulatory Affairs
- Quality Assurance
- Purchasing
- Production
- Engineering
- All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the establishment, monitoring, and review / audits of outsourced parts and services used in regulated medical products.
Faculty 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 41 years experience in U.S. FDA-regulated industries, 27 years 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 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
