FDAnews Announces Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance Management Report

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Will a drug’s process validation program stand up to FDA scrutiny? Ensure compliance with these strategies and methods. Order today.

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WCG FDAnews

Drugmaker’s Guide to Process Validation:
Principles, Methods and Compliance
FDAnews Management Report
https://www.fdanews.com/products/category/224-drug-books/product/61229

Has a risk-based plan to determine which aspects of a business needs validation been developed? Is the team prepared to prove the consistent performance of manufacturing equipment and its operating procedures?

Process validation can be confusing and complicated. Knowing exactly what the FDA and other regulators are expecting when it comes to validation will pave the way for a more straightforward, successful process — and this report can get one there.

With the Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance management report, readers will be able to align validation choices with the expectations of regulators. Discover the best methods for conducting a risk analysis, creating testing and sampling procedures and interpreting test results. With these expert tips, one will be able to develop an acceptable validation report and deal with any issues that may arise.

This report will cover:

  • The Basics of Validation

a.    Understanding different types of validation: prospective, retrospective and concurrent
b.    Determining roles concerning validation
c.    Matching the expectations of regulators

  • Developing a Validation Master Plan

a.    Creating a master plan, validation matrix and validation protocol
b.    Setting the scope of the master plan
c.    Considering whether to outsource validation

  • The Validation Process

a.    Applying risk management methods to validation
b.    Conducting risk analysis
c.    Defining critical quality attributes and process parameters
d.    Performing testing in different environments
e.    Writing test scripts
f.     Determining the advantages of executing test scripts electronically
g.    Interpreting results and preparing validation reports
h.    Dealing with validation problems

Validation is a critical but challenging part of drug manufacturing. Find the information needed to develop a successful validation plan in this management report.

Management Report Details:
Drugmaker’s Guide to Process Validation:
Principles, Methods and Compliance
FDAnews Management Report
https://www.fdanews.com/products/category/224-drug-books/product/61229

Price:
$397

Easy Ways to Order
https://www.fdanews.com/products/category/224-drug-books/product/61229
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
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