Buch, Englisch, 248 Seiten, Format (B × H): 181 mm x 208 mm, Gewicht: 548 g
Buch, Englisch, 248 Seiten, Format (B × H): 181 mm x 208 mm, Gewicht: 548 g
ISBN: 978-1-907568-58-9
Verlag: Elsevier Science & Technology
Autoren/Hrsg.
Fachgebiete
- Wirtschaftswissenschaften Betriebswirtschaft Management Compliance
- Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
- Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
Weitere Infos & Material
- Step-by-step basics on how to build a comprehensive CAPA program
- How to use a nine step CAPA process to effectively handle any product or quality system failures
- How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner
- How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk
- How to use Failure Mode and Effect Analysis to identify potential failure modes
- How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities
- Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
- Efficient use of root cause analysis tools
- Optimizing CAPA and RCA documentation procedures
- Essential SOPs and other documentation
- Review areas of common FDA's 483 inspection observations
- How to effectively identify and track deviations and non-conformances
- Learning to analyze and trend data to identify existing and potential causes of non-conformance
- Gathering, organizing and managing the correct data required to conduct an effective Root Cause Investigation
- Review the elements of a good investigation
- Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling
- Performing trend analysis and using effective RCA tools
- How to use of statistical methodologies when performing Root Cause Analysis
- CAPA and the linkage to effective management review and annual product reviews
- Step-by-step basics on how to build your own comprehensive CAPA program
- Most important: Review of the real benefits of an effective CAPA system