Deviations, Investigations and CAPA - Webinar By ComplianceOnline (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Aug 11, 2011||End Date/Time: Aug 11, 2011|
The agencies have focused over the last 2 years on the investigation/CAPA system as a critical Quality System that is required in a compliant operation. While the agencies have stepped up interpretation of the regulations and have more strongly enforced these regulations, industry has not responded well to this change as evidenced by the breadth and number of warning letters issued over the last 2 years in the US. Thus, this process takes a central position in operations since even the best planned and validated process can result in excursions that contribute to an outcome that is unexpected or unplanned and unwelcome.
Identifying these excursions quickly is critical in maintaining or returning your operations to a validated state. These identified events must be investigated and the root cause discovered. But, equally important is identifying what did not cause the problem. While, correcting these errors or excursions, if well executed, may save product that has been put in jeopardy, it is equally important to prevent their reoccurrence from a business and regulatory perspective. These Corrective and Preventive Actions (CAPA) must be tracked to completion and tested to assure that they are effective.