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Capa in the pharmaceutical and biotech industries : how to implement an effective nine step program /
CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop proc...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cambridge, UK ; Waltham, MA :
Woodhead Publishing,
[2016]
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| Colección: | Woodhead Publishing series in biomedicine ;
no. 33. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; Related titles; CAPA in the Pharmaceutical and Biotech Industries; Copyright; Dedication; Contents; Biography; Preface; Introduction; Corrective and preventive action (CAPA); What is an appropriate CAPA program?; Analyze data for trends; Preventive actions; 1
- Understanding the FDA's CAPA requirements and regulations; Part I. 21 CFR part 820.100 for medical devices; Part II. 21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals; Part III. The FDA's current inspectional approaches; Review of the quality system inspectional technique: medical devices
- QSIT and CAPAWhat is QSIT?; Part IV. QSIT and CAPA: inspectional objectives; Purpose/importance; Part V. Quality systems approach to pharmaceutical current good manufacturing practice regulation, September 2006; Background; In August 2002, the FDA announced the Pharmaceutical CGMPs for the Twenty-First Century Initiative; CGMPs and the concepts of modern quality systems; Review of the concept of corrective action; Preventive actions; Promote improvement; Part VI. ISO 13485 and CAPA: inspectional objectives; Measurement, analysis, and improvement; General; Monitoring and measurement
- (Customer satisfaction) feedbackMonitoring and measurement of processes; Control of nonconforming product; Analysis of data; Improvement; Continual improvement: general; Corrective action; Preventive action; Summary to part VI; 2
- Implementing a CAPA program: going back to basics; Corrective and preventive actions; General requirements; CAPA process; Quality data sources; Correction/remedial action; Evaluation of risk; Quality event risk-evaluation process; Investigation to identify problem cause(s); Management of CAPA; Initiation of CAPA; Cross-reference to other CAPAs; CAPA plan
- The CAPA planCAPA review board approval; Implementation/execution; Effectiveness check; Updating the risk evaluation; CAPA closure; Documentation; CAPA data analysis; CAPA process metrics; Closed-loop corrective action; CAPA review board actions; Interface with management review; 3
- The nine-step CAPA program; The nine-step process; An appropriate CAPA program; Importance of continuous improvement; Procedural essentials; Why include risk analysis in CAPA programs?; Risk-based decision-making; 4
- Step 1: identification of the event and writing a proper problem statement
- Write a detailed problem statementUse the "Ws" and "Hs"; Step 1: identification of the problem and effective compliance writing; Corrective and preventive action systems; Root cause/CAPA; Finding the root cause; Scenario 1; Scenario 2; Consider scenario 2; Root cause analysis: methods, whys, and the fishbone diagram; Understanding the problem statement and the evaluation of the event; What is an evaluation?; Seeking quality data; Document the problem; Explanation of the problem; Evidence; Evaluation; More on report writing; Problem statement 1; Problem statement 2; Problem statement 3