FDAnews Announces — New Management Report — Managing Process Validation: A Drugmaker’s Guide

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Manufacturers know process validation, but they are looking for more in-depth knowledge to take it to the next level. GMP Manual, written by pharma industry veteran and GMP specialist, Dr. Christine Oechslein, gives manufacturers the information needed to craft a solid validation program.

Managing Process Validation:
A Drugmaker’s Guide
**An FDAnews Management Report**
[http://info.fdanews.com/managing-process-validation-vocus    

Manufacturers know process validation. But, they are looking for more in-depth knowledge to take it to the next level.

Some expert advice might come in handy. Something like Peither’s GMP Manual —condensed with all of the salient points manufacturers need.

Managing Process Validation: A Drugmaker’s Guide, a condensed version of the GMP Manual, written by pharma industry veteran and GMP specialist, Dr. Christine Oechslein, gives manufacturers the information needed 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.

Who Will Benefit:

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

FDAnews Management Report Details:
Managing Process Validation:
A Drugmaker’s Guide
Price: $397
[http://info.fdanews.com/managing-process-validation-vocus

Easy Ways to Order:
Online: [http://info.fdanews.com/managing-process-validation-vocus        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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