The FDA's New Drug GMPs:What You Need to Train Your Staff by Dec. 8

Held Nov. 6, 2008

ALERT: On Sept. 8, the FDA released direct final rule revisions to the pharmaceutical cGMPs (21 CFR 210/211) that will go into effect Dec. 8.

That's just two months to take action and be in compliance with these changes! This means, in a very short period of time you must retrain your quality and manufacturing employees and rewrite SOPs and batch records.

But first, companies must gain a thorough understanding of the changes that are about to take place, including:

  • A ban on the use of asbestos filters
  • New validation requirements for all aseptic processing
  • The inclusion of bioburden testing in in-process testing
  • New requirements on the control of microbiological contamination
  • Changes to the double-check requirements for steps such as:
    • equipment cleaning
    • calculation of yield batch production and control records

 And to make matters worse, this comes at a time when the FDA is cracking down on GMP violations. Just ask Ransbaxy — the agency just banned more than 35 of its products from entering the U.S. due to two violations, one of which came about because an inspection by the FDA revealed significant deviations from U.S. cGMPs.

Time is of the essence! With only a few weeks to make changes to meet the new rules, companies need to move quickly to stay compliant.

The first place to turn for help is to well-known, trusted training and compliance expert Barbara Immel.

Barbara explores these new requirements and walks you step-by-step through each revision, clarifies the most confusing areas and provides a blueprint to get employees up to speed with these new changes.

Order now for your entire team to listen in and discover:

  • The GMP revisions that go into effect Dec. 8
  • What you need to retrain your employees
  • Areas that are confusing, clarification of these areas and pitfalls to avoid
  • The impact of the FDA's use of the direct final rule process
  • Summary of the recent Phase I clinical material exemption
  • Recent FDA inspection trends for drug and biologic manufacturers
  • A summary of recent serious compliance cases
  • An analysis of the latest cGMP warning letters issued by the FDA

Order now and you'll have a clear picture of what to do to comply with these new rules and how to get your company up to speed immediately.

This audio CD/Transcript is a must for contract manufacturers and professionals in the drug and biologic industries, including:

  • Compliance officers
  • Purchasing
  • Packaging and labeling
  • General/corporate counsel
  • Operations
  • Manufacturing
  • Plant engineering
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Regulatory/legislative affairs
  • Laboratory quality control
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Barbara K. Immel is president of Immel Resources LLC and editor of the Immel Report™. She has 26 years of industry experience. She worked in compliance and training, documentation and labeling, and corporate quality assurance for Syva, Chiron and Syntex for more than 12 years before starting the company.

Barbara served as a regulatory compliance columnist with BioPharm International magazine for more than 10 years (1996–2007). She has published more than 50 articles on a variety of industry topics in Pharmaceutical Technology, Medical Device & Diagnostic Industry, BioProcess International, Nutraceutical Business and Technology, Pharmaceutical Technology Europe, and BioPharm. She is the author of the Quality Assurance of Pharmaceuticals chapter for the Dekker Encyclopedia of Pharmaceutical Technology.

Order now!