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, esecially their CROs, CMOs, CDROs, per the CGMPs and ISO 13485 and other QMS'.  The infrastructure behind the COA / COC is being challenged. Risk ranking and Trending.Such changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.  In additon 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 affectingregulatory 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.

Areas Covered in the Session:

• The Globalization of the Supply Chain and What That Means
• CMOs, CROs, CDROs, Vendors…
• US FDA and EU MDR Requirements
• Avoid complacency from past "good" FDA / ISO audits
• COAs / COCs
• Mandated Supplier Controls; Change Controls - A Major Weak Point
• Supplier Trending and Ranking Models
•  Risk-Based Audit Approaches

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, Neutraceutical, Biologics and Combination products fields, with emphasis on devices.

"Why should you attend –

Recurring regulatory agencies' statements and actions indicate the past ways of managing a company's supply chain / outsourcing - CMOs, CROs, CDROs -  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 stratagies 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 thenselves 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.

Target Companies:

• Abbott Laboratories,
• Hospira,
• Cardinal,
• Pfizer,
• J&J,
• Integra and other medical product manufacturers.

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.