Stacey Bruzzese welcomes back Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about combination products and what you need to be aware of.
A review of the types of combo products, single-entity, co-packaged, and cross-labeled, as well as the FDA Guidance.
The FDA’s 9 classifications for combo products – download the table
Navigating a multi-approval process and successful development processes and timing
Aligning the clinical trial and design validation phases in order to be efficient.
Quality requirements under GMP and 21 CFR Part 4 including design controls for combination products to ensure that the product fulfils the requirements which were defined at the beginning of the project so that the final product fulfils the purpose.
Design controls, a design and development plan, development activities and defining responsibility for implementation.
Mitigating risk throughout the lifecycle of the product
Process for reporting adverse events for combination products
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Voices in Validation, Stacey Bruzzese, IVT Network, pharmaceutical, biotech, laboratories, medical devices, patient safety, quality control, United Podcast Network, Studio 21 Podcast Café, Alan Golden, Design Quality Consultants, change control, combination products,
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