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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:
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.
This is a must for combination products manufacturers, or anyone thinking about developing a combination product, including those involved in:
Suzanne O'Shea, J.D., is with the FDA practice group at Faegre Baker Daniels, a law firm with offices across the U.S. and in China. Ms. O’Shea focuses her practice on healthcare and life sciences initiatives. She is experienced in developing regulatory strategies enabling innovative, cutting-edge technologies to navigate through the FDA. She has extensive knowledge and experience in the drug, device, biological product, combination product, and human cells and tissues product life cycles. Her clients include start-up companies, mid-size and large corporations, and university research centers. Before joining Faegre Baker Daniels, Ms. O’Shea served for 21 years as regulatory counsel for the FDA. Most recently, she was product classification officer in the Office of Combination Products. In that capacity, Ms. O’Shae was responsible for classifying products as a drug, device, biologic, human tissue or combination product when the product's classification was unclear or in dispute.
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