Changing Supplier Controls Requirements
This training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA’s tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. Why Should You Attend: Recent FDA statements and actions indicate the past ways of managing a company’s supply chain / outsourcing will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. CGMP compliance cannot be passed on to suppliers; however suppliers must meet specific CGMP requirements. Proof for “better science” is also a new expectation. “Business as usual” is never acceptable. Don’t be caught of guard by these major shifts in emphasis. This presentation will help you refine supplier management and audits to match the FDA’s tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / compliance and vendor audits in light of the changes in the FDA’s CGMP supplier management “paradigm”. Once potential problem areas are identified, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. Areas Covered in the Webinar: -he Globalization of the Supply Chain and What That Means -Avoid complacency from past “good” FDA / ISO audits -Supplier Ranking Models -Mandated Supplier Controls; Change Controls COAs / COCs -The Tiered Risk-Based Audit Approach -“Entropy”; Maintain “the Edge” / “State of Control” Who Will Benefit: The following personnel from Medical Device, Diagnostic, Pharmaceutical, Neutraceutical and Biologics fields will benefit: -Senior management -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. Instructor Profile: John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company. He has over 32 years experience in U.S. FDA-regulated industries, 18 years of which have been as a full time, practicing consultant. John has worked with companies from start-up o 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, and conducted workshops and webinars worldwide. He is a graduate of UCLA. For Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702277?channel=limesfinder
