The U.S. FDA and the EU’s MDR continue to raise their requirements for tighter control and management of vendors, suppliers, and outsourcing — especially for CROs, CDMOs, and CMOs. Today’s supply-chain shortages compound the problem and have increased public concern over insufficient oversight of the entire medical-product supply chain.

There has been a major shift in emphasis in EU (and U.S. FDA) requirements for supplier regulatory and cGMP compliance, with growing recognition of the global nature of the supply chain. Companies are now expected to tightly manage their entire chain, including CMOs, CROs, and CDMOs. The infrastructure behind the COA/COC is being challenged, and these shifts have a major impact on compliance objectives, efforts, and measures of success — affecting how agencies approach inspections and audits.

Recurring agency statements and actions indicate that past ways of managing a company’s supply chain are no longer acceptable. Ultimate responsibility rests with the product-owning company, while suppliers themselves must meet specific cGMP requirements, and there are new expectations for the accuracy of COAs and COCs. The webinar evaluates these changes so companies can refine supplier management and audits to match growing regulatory requirements.

Webinar takeaway:

• The globalization of the supply chain and what that means
• CMOs, CROs, and CDMOs considerations
• Avoiding complacency from past “good” FDA / ISO audits
• COAs / COCs
• Mandated supplier controls; change controls — a major weak point
• Supplier trending and ranking models
• A TPLC risk-based audit approach

After this webinar, attendees will be able to answer -

• How has the emphasis of FDA and EU MDR requirements for supplier and outsourcing control shifted?
• What does tightly managing CMOs, CROs, and CDMOs across a global supply chain actually require?
• Why are COAs and COCs, and the infrastructure behind them, being challenged?
• Where does change control most often become a weak point in supplier management?
• How can supplier trending and ranking models and a TPLC risk-based approach improve audits?
• How can a company perform a gap analysis and put fixes in place to ensure continuing compliance?

This webinar benefits the following agencies -

The session addresses U.S. FDA and EU MDR expectations for supplier, vendor, and outsourcing management across the medical-product supply chain. It is relevant to product-owning companies and their CMOs, CROs, and CDMOs in FDA- and EU-regulated industries.

Who should attend?

This information applies to personnel and companies in the Medical Device, Pharmaceutical, Diagnostic, Nutraceutical, Biologics, and Combination Products fields (with emphasis on devices), including:

• Senior Management
• Research & Development (R&D)
• Regulatory Affairs (RA)
• Quality Assurance (QA)
• Purchasing
• Production
• Engineering

All personnel involved in establishing, monitoring, and auditing outsourced parts and services