🎤 John E. Lincoln | 📅 November 27, 2024 | 🕒 11 AM Eastern Time US
Why Should You Attend:
The U.S. FDA and the EU's MDR continue to increase their requirements for tighter control and management of vendors / suppliers / outsourcing. And supply chain shortages further compound the problem.
Recurring regulatory agencies' statements and actions indicate the past ways of managing a company's supply chain / outsourcing are not acceptable. 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.
Areas Covered in the Session:
Who Should Attend:
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, Neutraceutical, Biologics and Combination products fields, with emphasis on devices. The employees who will benefit include: