Managing Process Validation: A Drugmaker’s Guide

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Managing Process Validation
A Drugmaker's Guide

Few things in drugmaking are as challenging as process validation — nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that it's been done.

What validation method should you use? Who should be involved in validation? When should you conduct the validation?

You are beyond the introduction to process validation and ready to get straight to the heart of the matter.

Managing Process Validation: A Drugmaker's Guide — written by pharma industry veteran and GMP specialist, Dr. Christine Oechslein — gives you the information you need to craft a solid validation program, including:

  • How to choose the appropriate validation method (prospective, retrospective or concurrent)
  • How to build a validation team and assign tasks and responsibilities
  • Factors to consider when outsourcing validation
  • Setting critical process parameters and operational ranges
  • Dealing with equipment calibration and qualification
  • Validating computer systems
  • How to develop a validation matrix
  • What information to include in a validation protocol
  • How to document the validation

Order Managing Process Validation: A Drugmaker's Guide and gain the confidence to conduct process validations that reduce risk and satisfy regulators.


PDF Edition

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PDF Edition — $397

Who Will Benefit

  • Quality manager
  • Regulatory/
    compliance manager
  • Manufacturing floor manager

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