FDAnews Announces Combination Products cGMP Final Rule: Former FDA Official Helps You Navigate the Combination Products Minefield, On-Demand Webinar, Oct. 1, 2014
Falls Church, VA (PRWEB) September 11, 2014 -- 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 the next inspection? Attend this on-demand webinar and let a former FDA official explain what the FDA expects from manufacturers.
Mark the calendar for Wednesday, Oct. 1, for On-Demand access to Suzanne O’Shea’s immensely popular webinar on combination products.
Here’s what satisfied registrants had to say on what they liked about this webinar:
• “[I liked] the topic and that the presentation got into specifics regarding what a quality organization will need to do to be compliant.”
• “Very timely subject matter. Presenter seemed to know the topic well.”
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 attendees with information about these two important FDA initiatives, and discuss issues that can arise from human factors requirements for combination products.
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 manufacturers 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, 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 it be bent? 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
There are few as qualified to walk attendees through the guidance, as Ms. O’Shea is a 21-year veteran of the FDA and a combination products expert, and fewer still who can take attendees inside the FDA to explain the agency’s goals and motivations on cGMPs, human factors, postapproval changes and then show 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.
Please note this webinar was previously recorded in March 2013 and no questions will be taken during the presentation. Attendees may listen to the recording at their convenience on Oct. 1.
Who Will Benefit:
This is a must-attend session for combination products manufacturers, or anyone thinking about developing a combination product, including those involved in:
• Product development
• Manufacturing officers
• Compliance officers
• General/corporate counsel
Meet Your Instructor:
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.
Conference Details:
Combination Products cGMP Final Rule: Former FDA Official Helps You Navigate the Combination Products Minefield
**FDAnews On-Demand Webinar**
Oct. 1, 2014 ● Any Time at Your Convenience
http://www.fdanews.com/OnDemandComboProducts
Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register:
Online: http://www.fdanews.com/OnDemandComboProducts
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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