Why Should You Attend:
Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing are not acceptable. The U.S. FDA has opened eleven of it's own branches in Mainland China, India, and other major areas of the world to train their local counterparts and to better address and audit regulatory compliance of suppliers of medical products and components destined for the U.S. CGMP compliance cannot be passed on to suppliers. Suppliers thenselves must meet specific CGMP requirements. Proof for "better science" is also a new expectation and is already having its effect on COAs and COCs. Combination products serve to compound the problems. Don't be caught of guard by these major shifts in emphasis. Refine supplier management and audits to match the growing FDA requirements.
There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance. The FDA has implemented major global initiatives. Companies are required to tightly manage their entire supply chain. 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. The Agency is reacting to increasing negative publicity due to major publicized product failures / recalls / and 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. Combination product add further complexity. "Better science" requirement impacts suppliers as well. All this is affecting the Agency's approach to inspectioina / 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.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / ccompliance and vendor audits in light of changing FDA's CGMP 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 Pharmaceutical, Medical Device, Diagnostic, Neutraceutical, Biologics and Combination products fields. The employees who will benefit include:
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 ptublished 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.
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