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.
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.
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 off 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:
- The 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 the 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
Course Provider
John E Lincoln,
