Pharmaceutical Investigation and CAPA System Assessment and Training

Pharmaceutical failure investigations and CAPA system weaknesses are consistently among the top most frequently cited regulatory observations and the top finding in FDA warning letters. The most common regulatory concern is that investigations fail to thoroughly conduct root cause analysis (RCA) and fail to link corrective and preventative actions to the root causes identified. Often companies are cited for not considering the potential magnitude of an event or not considering other batches previously produced and possibly released into the market.

Our program, which brings together expertise from several disciplines, addresses each of these weaknesses through a comprehensive approach to pharmaceutical investigation system improvement. Our services include investigation system assessment, root cause analysis training and investigator certification. Each of the elements can be selected individually or combined depending on your company’s needs and priorities. Linking RCA analysis training to investigator certification has proven to provide sustainable results and an impressive return on investment. By finding and addressing root cause, pharmaceutical failure investigation rates drop and the resulting savings more than offset the company investment in training and assessment.

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