All manufacturers of combination products 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? Attend this on-demand webinar and let a former FDA official explain what the FDA expects from you. Mark your calendar for Wednesday, Oct. 1, for On-Demand access to Suzanne O’Shea’s immensely popular webinar on combination products.
The FDA has issued a final rule on cGMPs for combination products—and issued a guidance document on postapproval changes. This on-demand webinar 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. Attendees will leave with 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. Sign up to attend this 90-minute on-demand webinar on Oct. 1, 2014, 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—what changed 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 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-attend session for combination products manufacturers, of course, and also for anyone in tissue and cellular organizations, drugs, devices, biologics or diagnostics. Critical, too, if you provide outside counsel, so make plans now to attend this valuable, on-demand webinar on Wednesday, Oct. 1. Please note; this webinar was previously recorded in March 2013 and no questions will be taken during the presentation. You may listen to the recording at your convenience on Oct. 1.
For more information and to sign up, click here.