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
• Further Information: Note: By J. Rodriguez.
• Authors: Rodríguez, J
• Contents: 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.
• Publisher Details: Oxford : Woodhead Publishing
• Publication Date: 2015
• Extent: 1 online resource
• Subjects: 615.1900685; Pharmaceutical industry -- Quality control; MEDICAL -- Pharmacology; Pharmaceutical industry -- Quality control; Electronic books
• Languages: English
• ISBNs: 9781908818379; 1908818379
• Related ISBNs: 1907568581; 9781907568589
• Notes: Note: 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.