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Handbook of Investigation and Effective CAPA Systems 3rd Edition by Jose Rodriguez Perez ISBN 1636940110 9781636940113

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Handbook of Investigation and Effective CAPA Systems 3rd Edition José Rodríguez-Pérez Digital Instant Download

Author(s): José Rodríguez-Pérez
ISBN(s): 9781636940113, 1636940110
Edition: 3rd
File Details: PDF, 9.55 MB
Year: 2022
Language: english
SKU: EB-50038904 Category: Tag:

Handbook of Investigation and Effective CAPA Systems 3rd Edition by José Rodríguez-Pérez – Ebook PDF Instant Download/Delivery: 1636940110, 9781636940113

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Product details:

ISBN 10: 1636940110 

ISBN 13: 9781636940113

Author: José Rodríguez-Pérez

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 the 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

Table of contents:

  1. The Quality System and the Investigation and CAPA Element

  2. Investigation and CAPA Requirements for the Life Sciences–Regulated Industry

  3. ISO 9001:2015: Nonconformance and CAPA Requirements

  4. Effective Investigation and CAPA Processes: From Problem Detection to Effectiveness Check

  5. Human Error Investigation and Reduction

  6. Laboratory Investigations

  7. The Biggest Opportunities of the Investigation/CAPA System and How to Fix Them

  8. Developing an Internal Investigation and CAPA Expert Certification

  9. Documenting Investigation and CAPA: Forms and Examples

  10. Appendix

  11. Acronyms

  12. Glossary

  13. References

  14. Index

  15. About the Author

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Tags: Jose Rodriguez Perez, Handbook, Investigation, Effective, CAPA, Systems