Upcoming Events
cGMP Expectations for Drug-led versus Device-led Combination Products
Thursday, April 18, 2024 (11:00 AM - 12:00 PM) (EDT)
Description
Join us to discuss the combination product CGMP operating system requirements that support development, manufacturing, premarket regulatory evaluation, and commercialization of combination products.
SPEAKERS
 | Susan Neadle, MS, BS, FRAPS, FAAO President Combination Products Consulting Services LLC Susan Neadle, MS, BS, FRAPS, FAAO, is an internationally recognized and award-winning Combination Products and Medical Device expert. Following her retirement from an impactful career at Johnson & Johnson, she remains highly active in numerous industry groups and teaching institutions. She is President of Combination Products Consulting Services LLC, applying her extensive experience to provide training and global quality, regulatory affairs, executive advisory and R&D design/process excellence services. She also serves as Co-Chair of the AAMI Combination Products Steering Committee and Chair of the ASTM International Combination Product Working Group. She has recently published “The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems” through CRC Press (www.routledge.com/9781032291628). |
 | Hope Tuck VP, Quality & Compliance Gilero Hope has over 25 years of experience in Pharmaceutical and Medical Device Quality. Prior to Gilero, she led multiple Quality groups with expertise in Design and Development, Operational Quality and Quality Systems. She has been on both sides of contract partnerships and enjoys the relationship building necessary to ensure success for stakeholders. As the VP of Quality & Compliance, Hope always keeps the patients in mind for every decision. Hope adds great Quality expertise to Gilero’s leadership team, and she utilizes her knowledge in automated assembly, audits, systems automation to come up with impactful solutions to improve the quality systems and processes here at Gilero. She aims to be a positive vehicle to improve the lives of patients, and their caregivers. Hope knows the importance of compliance when it comes to patient safety and continuously sets her sights on improving Gilero’s quality system to support successful projects. In addition, Hope has aseptic manufacturing experience, and has received her certification in multiple lean and six sigma initiatives. Hope received her Bachelor of Science in Engineering Science and Mechanics from Virginia Polytechnic Institute and State University. |
 | Jim Fentress Director of Regulatory Affairs Gilero Jim brings to Gilero more than 20 years of disposable medical device experience, with a strong foundation in device design, manufacturing, process development, validation, and experiment design. Before coming to Gilero, Jim worked in product development, manufacturing, and research and development at Becton Dickinson and CareFusion. Prior experience focused on long-term device and drug development, high-volume disposable devices, needle-free access devices, pump systems, and anti-microbials. In his role as Director of Research & Development and Regulatory Policy at Gilero, Jim focuses on novel product development with new technologies, materials, or requirements. Jim also acts as a technical consultant on traditional development products providing guidance for design verification and validation testing, test method development, regulatory submissions, and regulatory body correspondence. Jim holds a degree in Biomedical Engineering from Rensselaer Polytechnic Institute. In 2022, Jim moved to Athlone, Ireland to kickstart Gilero’s first European design center. |
Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. The FDA regulation of combination products, 21 CFR Part 4, became effective 22 July 2013. Final guidance on CGMPs for combination products was issued in January 2017, and a list of alternative or streamlined mechanisms for compliance with CGMPs for combination products was later issued in September 2022.