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 — $397
Who Will Benefit
Regulatory/ compliance manager
Manufacturing floor manager
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