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Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects’ to identify other quality issues in order to minimize risks (including safe ones) and reduce costs.
Enhancements to this third edition include:
- A new section linking the investigation and CAPA programs with the overall quality culture of the company
- Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485
- Updated inspectional observations from the U.S. FDA and U.K. MHRA
- A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process
- New charts and information related to the investigation of human errors; the human factor section includes information about training and competence
- A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results
- Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error
