CAPA CONTENT Package

50 Pages of exclusive "how to" articles, SOP template, Checklist and Form.

➢ 1. A Guide to Effective Management Practice - Part I: CAPA Basics (Article)

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➢ 2. A Guide to Effective Management Practice - Part II: Datastream Analysis for Identifying CAPA Items (Article)

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➢ 3. CAPA SOP TEMPLATE

➢ 4. CAPA SOP Auditing CHECKLIST

➢ 5. Failure Investigation and CAPA Implementation FORM

1. A Guide to Effective Management Practice - Part I: CAPA Basics (Article)

Click here to view complimentary excerpt

A high percentage of Warning Letters issued by FDA in recent years includes citations for ineffective or deficient CAPA systems. In this article, you will learn the basic GMP requirements for CAPA, and how an effective CAPA system can result in significant product and process improvements in your company's operations. Subject matter includes the following: Defining CAPA, Identification of negative trends through periodic analysis, Process improvement initiatives, which include examples of CAPA, Root Cause, Why CAPA actions should be SMART (includes chart for easy reference, FDA expectations and much more. Plus....

Bonus Material

10 Questions and Answers related to this article are included to test your knowledge retention.

2. A Guide to Effective Management Practice - Part II: Datastream Analysis for Identifying CAPA Items (Article)

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A must read article for implementing datastream analysis-a key element of an effective CAPA system. In Part II of this article, CAPA basics are first reviewed. Then the three basics elements that result in permanent corrective/preventive actions are discussed: (1.) Reaction to unplanned or unexpected events. (2.) Identification of negative trends through periodic analysis. (3.) Process improvement initiatives.

Root cause, GMP requirements, FDA expectations, identification of root cause, effective CAPA management, execution of CAPA action items, documentation requirements, effectiveness checks and management oversight are also reviewed. Several charts for easy reference are also included in this article.

Bonus Material

17 Questions and Answers related to this article are included to test your knowledge retention.

3. CAPA SOP TEMPLATE

The purpose of this ten (10) page procedure is to define general and specific requirements for the identification, initiation, management, control, monitoring, closure and oversight for the Corrective And Preventive Action (CAPA) system.

4. CAPA SOP Auditing CHECKLIST

This six (6) page checklist contains 26 items for verifying that requirements identified in the SOP template for CAPA related to development, implementation and training are correctly implemented.

5. Failure Investigation and CAPA Implementation FORM

This five (5) page form includes 9 critical areas including: general information, define: issue description; measure: summary of investigation; analyze: analysis of investigational data and ID of root cause; analyze: impact on company systems and processes; risk management; innovative improvement: action items and implementation plan; control: baseline and effectiveness monitoring.

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