Corrective & Preventative Action (CAPA) & Out of Specification (OOS)

Venue: London

Location: London, United Kingdom

Event Date/Time: Mar 16, 2009 End Date/Time: Mar 17, 2009
Early Registration Date: Jan 15, 2009
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This two-day training course will guide and develop your understanding of:

• Regulatory Requirements for CAPAs and OOS Investigations
• Secure Strategies for Compliance
• How to Maximize Benefits from CAPAs and OOS Investigations
• 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.