Developing a Compliant Drug Validation Plan

Quantity Discounts
1 - 2
3 - 4
5 - 6
7 - 9
10 - 9999
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.

Order Your Copy Today!

PDF Edition

Available Format

PDF Edition — $397

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

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library – a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.