FDAnews Announces — The Road to a Pharmaceutical Quality System in the EU Management Report

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Does one’s quality management systems comply with EU standards? Implement a problem-solving approach at every level of your operations.

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WCG FDANews

The Road to a Pharmaceutical Quality System in the EU
An FDAnews Management Report
https://www.fdanews.com/products/category/101-books/product/59517-the-road-to-a-pharmaceutical-quality-system-in-the-eu

Does one’s quality management system comply with EU standards?

In The Road to a Pharmaceutical Quality System in the EU, international quality management and auditing expert Stephanie Blum explains the EU’s PQS requirements — including ISO standards and ICH guidelines. She provides direction on how to build a system that will keep readers manufacturing operations compliant and in a state of control, including:

  • The key elements of the PQS
  • The roles that quality policy and quality planning play
  • The responsibilities of management
  • The regulatory requirements implemented in practice
  • The significance of documentation for the PQS
  • Whether or not a PQS documentation hierarchy (documentation pyramid) is necessary
  • What GMP documentation a pharmaceutical company needs
  • What a quality manual is and how to create it
  • Why and how to carry out a management review
  • How to define suitable key performance indicators
  • What results a management review delivers and how it is evaluated

Take control of operations — build a PQS that implements a problem-solving approach at every level of the manufacturing operations.

Management Report Details:
The Road to a Pharmaceutical Quality System in the EU
An FDAnews Management Report
https://www.fdanews.com/products/category/101-books/product/59517-the-road-to-a-pharmaceutical-quality-system-in-the-eu

Management Report PDF:
$100

Easy Ways to Order:
Online: https://www.fdanews.com/products/category/101-books/product/59517-the-road-to-a-pharmaceutical-quality-system-in-the-eu
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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