Best Practices for FDA-Compliant Drug and Biologic Manufacturers

By: Fdanews  09-12-2011
Keywords: drug

Glean real-world insight with examples of working change control systems, specifically targeted to the unique needs of drug and biologic manufacturers, with the new management report brought to you by FDAnewsChange Control: Best Practices for FDA-Compliant Drug and Biologic Manufacturers.

This report is your guide to the FDA’s change control requirements for drug and biologic manufacturers, with targeted topics that let you:

  • Understand drug and biologic regulatory requirements for change control
  • Discover what types of changes must be submitted to the FDA
  • Analyze current FDA change control inspection trends
  • Untangle the FDA’s new Quality System Guidance as it relates to change control

Included are working examples of change control systems, along with procedures and forms. In addition, you’ll acquire actionable strategies you can use right away for your own change control systems as you:

  • Access industry-wide best practices in change control from your drug and biologic peers
  • Gain effective tips and techniques to avoid change control problems
  • Use how-to advice for managing and implementing effective change control

Nine Complete Chapters Focus on Change Control From a
Manufacturing and Quality Assurance Perspective

Understand where change control problems can occur, and how they’ll affect you. This report specifically looks at change control from a manufacturing and quality assurance perspective, with chapters that include:

  • When Change Control Fails
  • Regulatory Highlights
  • When Do Proposed Changes Require Approval?
  • What Does the FDA Expect at Inspection Time?
  • Common Sense Procedures
  • Change Control as a Formal Process
  • Reviewing Proposed Changes
  • Handling Deviations and ‘Temporary’ Changes
  • And more

Buy Now!
Don’t risk million-dollar losses from lawsuits, product recalls, or damaging publicity that can result from change control failures, order today! Change Control: Best Practices for FDA-Compliant Drug and Biologic Manufacturers is available for $395, in print or online.

Interested in purchasing more than one print copy?
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. Order below by clicking submit and then change your quantity in the shopping cart. 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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The information in this article was current at 06 Dec 2011

Keywords: drug