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