Medical Device 2012 - Supplier Controls to Meet Tougher U.S. FDA Requirements
Date2012-05-22
Deadline2012-05-22
VenuePalo Alto, USA - United States
KeywordsSupplier Controls; U.S. FDA Requirements; Supplier Ranking Models; CGMP compliance; supplier management; supplier audit
Topics/Call fo Papers
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.
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"
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- KDD 2012 Workshop on Crowdsourcing and Data Mining
- CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps
Last modified: 2012-03-19 15:02:01