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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 products add further complexity. "Better science" requirement impacts suppliers as well. All this is affecting the Agency's approach 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:
Recent FDA statements and actions indicate that past ways of managing a company's supply chain/outsourcing are not acceptable. The U.S. FDA has opened eleven of its 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 themselves must meet specific CGMP requirements. Proof for "better science" is also a new expectation and is already having an effect on COAs and COCs. Combination products serve to compound the problems. Don't be caught off guard by these major shifts in emphasis. Refine supplier management and audits to match the growing FDA requirements.
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