Recalls from A to Z: Regulations, Decisions, Procedures, & Best Practices
Recalls from A to Z: Regulations, Decisions, Procedures, & Best Practices
Product Overview
How should medical technology companies responsibly manage product recalls? This conference provides practical guidance from both regulatory and business perspectives on handling this troubling action. Key experts from FDA’s Center for Devices and Office of Enforcement, together with leaders from industry, discuss FDA regulations, guidances and expectations, internal company decision-making issues, productive communications between companies and FDA, and effective recall procedures.
- Communicating with FDA – Before, During and After- and What the Regulation Requires
- Health Hazard Evaluation and Classification
- Communications – Effective Recall Letters and Press Releases
- How Firms Can Simplify Recalls
- Product Retrieval Issues
- Terminating a Recall
- Crisis Management and Recalls – Preparedness & Infrastructure
- Product Liability Considerations
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