CAPA in the pharmaceutical and biotech industries : how to implement an effective nine step program /: how to implement an effective nine step program. (2015)
- Record Type:
- Book
- Title:
- CAPA in the pharmaceutical and biotech industries : how to implement an effective nine step program /: how to implement an effective nine step program. (2015)
- Main Title:
- CAPA in the pharmaceutical and biotech industries : how to implement an effective nine step program
- Further Information:
- Note: By J. Rodriguez.
- Authors:
- Rodríguez, J
- Contents:
- 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 RCAStep-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 … (more)
- Publisher Details:
- Oxford : Woodhead Publishing
- Publication Date:
- 2015
- Extent:
- 1 online resource
- Subjects:
- 615.1900685
Pharmaceutical industry -- Quality control - Languages:
- English
- ISBNs:
- 9781908818379
- Notes:
- Note: Description based on CIP data; resource not viewed.
- Access Rights:
- Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
- Access Usage:
- Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.
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- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library HMNTS - ELD.DS.44490
- Ingest File:
- 02_182.xml