Overview
The U.S. FDA and the EU's MDR continue to increase their requirements for tighter control and management of vendors / suppliers / outsourcing. This is especially important with CROs, CDMOs and CMOs. Today's supply chain shortages further compound the problem.
There has been a major shift in the emphasis of EU (and U.S. FDA) requirements for supplier regulatory / CGMP compliance. There is a recognition of the global nature of the supply chain.. Companies are required to tightly manage their entire supply chain - especially including CMOs, CROs, and CDMOs. The infrastructure behind the COA / COC is being challenged. Such changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. In addition to the existing problems with supplier compliance, change control, there is now the problem of notable recent product shortages, leading to public concern over insufficient oversight of the entire medical product supply chain, including global outsourcing. Of both raw materials, components, as well as services. All this is affecting regulatory agencies' approaches to inspections / audits and their expectations for companies. These areas of change will be evaluated to see how to better prepare for and address supplier chain management and vendor audits.
Why Should You Attend
Recurring regulatory agencies' statements and actions indicate the past ways of managing a company's supply chain / outsourcing are not acceptable. This is especially true of CMOs (Contract Manufacturing Organizations), CROs (Contract Research Organizations), and CDMOs (Contract Development and Manufacturing Organizations). The medical products supply chain is a complex global enterprise. Regulatory agencies are increasingly recognizing that fact and incorporating it into their strategies to better address and audit the regulatory compliance of suppliers of medical products and components destined for their respective countries. Ultimate responsibility rests with the product-owning company. Suppliers themselves must meet specific CGMP requirements. There are new expectations for the accuracy of COAs and COCs. Don't be caught off guard by these major shifts in emphasis. Refine supplier management and audits to match the growing regulatory requirements.
Webinar Takeaway
- The Globalization of the Supply Chain and What That Means
- CMOs, CROs and CDMOs considerations.
- Avoid complacency from past "good" FDA / ISO audits
- COAs / COCs
- Mandated Supplier Controls; Change Controls - A Major Weak Point
- Supplier Trending and Ranking Models
- A TPLC Risk-Based Audit Approach
Who Will Benefit
This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / compliance and vendor audits in light of growing regulatory supplier management 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 Medical Device, Pharmaceutical, Diagnostic, Nutraceutical, Biologics and Combination products fields, with emphasis on devices. 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.
