Developing a Compliant Drug Validation Plan

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Inadequate validation of electronic record keeping is a frequent citation in FDA 483s and warning letters.

This management report will tell you how to develop and implement a drug validation plan that will satisfy FDA and international regulators.  It focuses on using ASTM E2500 and ICH Q9 to create risk-based assessments that increase compliance, minimize the spiraling costs of validation and reduce project delivery time.  This report also provides a step-by-step approach to the planning, execution and reporting of computer system validation activities. 

You will learn:

  • Why ASTM E2500 and ICH Q9 are superior;

  • Why “qualification” is a more accurate term than validation;

  • How to execute a risk assessment and use it for engineering, maintenance and change control decisions;

  • How to perform testing in different environments;

  • Tips for writing test scripts;

  • 5 advantages to executing test scripts electronically;

  • How to use GAMP 5 to determine a system’s software category;

  • Prerequisites for testing such as available documents, definition of components and data for testing different scenarios;

  • How to execute screen captures to facilitate third-party reviews;

  • Step-by-step approaches to documenting and resolving nonconformances; and

  • Establishing traceability as proof of system functionality.

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Table of Contents

  • Introduction
  • Process Validation
  • Process Design
  • Process Qualification
  • And More …

View the entire TOC

Who Will Benefit

  • Executive management
  • Manufacturing directors and supervisors
  • Production teams
  • Validation officers
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Compliance officers
  • Data management and statistics personnel
  • Engineering and design controls teams

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