PDF Edition - FDA Pharma Manufacturing Essentials: Executive Briefings on 15 of Your Biggest Challenges

February 2011
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The blizzard of challenges faced by quality and regulatory affairs professionals never lets up. But keeping up with the changes and best practices in the hyper-demanding pharmaceutical industry can seem impossible.

Now there's help…

FDA Pharma Manufacturing Essentials brings together tested and practical advice that tackles the most pressing issues a pharma executive faces ... all in one, high-level and comprehensive resource. For one low price, you'll receive concise, powerful briefings on topics such as:

  • What the FDA expects to see in change control processes
  • Requirements for electronic signatures (Part 11)
  • Using process mapping and other tools to prepare for inspections

You can use FDA Pharma Manufacturing Essentials like a yearbook — assessing how the regulatory events will affect every aspect of your business in the coming year.
And, you’ll find complete updates on key quality issues, showing you the latest ideas to:

  • Reduce human error on the manufacturing floor
  • Maintain compliant batch records
  • Write and maintain effective standard operating procedures
  • And much more

You’ll want to put FDA Pharma Manufacturing Essentials to work in your facility right away. In fact, read on to learn how you can buy copies for your key personnel at a significant multi-copy discount.

It’s the desktop reference you'll use not only today but for years to come. Order FDA Pharma Manufacturing Essentials, today.

Readers include:

  • Top Management
  • Line Manufacturing Executives and Engineers
  • Quality Officials
  • Regulatory affairs professionals
  • Compliance officers
  • Legal
  • Consultants/service providers

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

Need Extra Print Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.

3-4 copies – 10%

5-6 copies – 15%

7-9 copies – 20%

10+ copies – 25%

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