Supplier Controls to Meet Tougher U.S. FDA Requirements

This 90-minute webinar on supplier controls will help you refine your 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.

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.

Areas Covered:

• The Globalization of the Supply Chain and What That Means
• Avoid complacency from past "good" FDA / ISO audits
• Supplier Ranking Models
• Essential Supplier Controls
• Where to direct scarce resources
• The Tiered Risk-Based Audit Approach
• Maintain "the edge"; proactively address "entropy"

Who Will Benefit:

The following personnel from 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.