FDAnews Announces — New Management Report — Drugmaker’s Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and FDA Compliance

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FDA investigators want to see that manufacturers understand their products and processes and are implementing procedures properly. Drugmaker’s Guide to ASTM E2500 explains the principles of ASTM E2500, uses case studies to show how to best implement it and shows how to use the standard to fulfill FDA expectations.

Drugmaker’s Guide to ASTM E2500:
Best Practices for Increasing Process Efficiency and FDA Compliance
**An FDAnews Management Report**
http://www.fdanews.com/products/54394-astm-e2500

FDA investigators want to see that drugmakers understand their products and processes and are implementing procedures properly. Following the ASTM E2500 helps drugmakers stay on track and generates the documentation needed to convince investigators.

Drugmaker’s Guide to ASTM E2500 explains the principles of ASTM E2500, uses case studies to show how to best implement it and shows how to use the standard to fulfill FDA expectations. Readers will learn:

  •     How the standard helps identify critical areas and verify that they are working properly
  •     How to meld Good Manufacturing Practices with Good Engineering Practices so quality and technical departments can work effectively together
  •     How to develop Commissioning Test Plans
  •     How to present key data to FDA investigators

Use ASTM E2500 to increase production efficiency and present a positive picture to the FDA.

Who Will Benefit:

  •     Engineering
  •     Project Management
  •     Commissioning and Qualification
  •     Quality Assurance
  •     Regulatory Affairs
  •     Manufacturing and Operations

FDAnews Management Report Details:
Drugmaker’s Guide to ASTM E2500:
Best Practices for Increasing Process Efficiency and FDA Compliance
Price: $397
http://www.fdanews.com/products/54394-astm-e2500

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54394-astm-e2500
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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