Combination Products cGMP Final Rule - Webinar CD/Transcript
Combination Products cGMP Final Rule: Former FDA Official Helps You Navigate the Combination Products Minefield
After eight years of waiting, the FDA has finally issued its long-sought-after final rule on cGMPs for combination products.
The FDA is serious in applying this rule. The agency spelled out in the guidance’s preamble that the rule applies to all combination products — regardless of whether they were approved before or after the rule’s effective date.
All combination products manufacturers will need to conduct a comprehensive gap analysis and determine where to make changes to their manufacturing operations, SOPs, training programs and quality assurance.
Why risk a delay in production? Why get dinged on your next inspection? Let a former FDA official to get you up to speed before the rule goes into effect.
This CD and transcript will provide you with information about these two important FDA initiatives, and discuss issues that can arise from human factors requirements for combination products.
Face the process with an expert guide at your side and you’ll not only navigate this regulatory minefield with confidence, you’ll give your combination product a competitive edge that lasts for years.
It doesn’t get better than this: FDAnews presents former Products Classification Officer with the FDA’s Office of Combination Products, Suzanne O’Shea, J.D., who speaks straight to the heart of your concerns in Combination Products cGMP Final Rule. Gain a better understanding of how the FDA thinks about combination products. This understanding will enable development of better quality systems, human factors testing, and management of postapproval changes.
Order today and access the insights and information that only a former FDA insider can give you, such as:
- In-depth analysis of the final cGMP rule for combination products — is it really any different from the proposed rule?
- How flexible is the framework the FDA sets forth in the final rule: Where can you bend it? Where will it break?
- What does the FDA recommend for post-approval changes for combination products?
- Case-study examples of various combination products
- And more, including inside tips for interacting effectively with the appropriate FDA centers
You’ll find few as qualified to walk you through the January 2013 guidance — Ms. O’Shea is a 21-year veteran of the FDA and a combination products expert — and fewer still who can take you inside the FDA to explain the agency’s goals and motivations on cGMPs, human factors, postapproval changes and then show you how to best prepare for them.