Corrective & Preventative Action (CAPA) & Out of Specification (OOS)
|Event Date/Time: Mar 16, 2009||End Date/Time: Mar 17, 2009|
|Early Registration Date: Jan 15, 2009|
â€¢ Regulatory Requirements for CAPAs and OOS Investigations
â€¢ Secure Strategies for Compliance
â€¢ How to Maximize Benefits from CAPAs and OOS Investigations
â€¢ How to Manage Typical Issues that Arise
Both FDA and European Regulators expect pharmaceutical products manufacturers to have in place a system for CAPA to correct process deficiencies and maximise process improvement. In addition, manufacturers must have a secure system for management of Out of Specification Results (Non-Conformances) to ensure that all product on the market is safe and meets its registration requirements.