Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker скачать в хорошем качестве

Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker

Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face (and one of the easiest places to lose time and momentum). The FDA Group's Nick Capman sits down with with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later. Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable. A few key takeaways: Early quality work should be right-sized, not commercialized prematurely Design space, material variability, and sensitivities must be understood and documented early FMEA works best when it evolves with the product—not when it’s treated as a one-time exercise FDA and EU requirements can diverge in ways that materially affect submission timing Clear documentation and regular, direct communication prevent avoidable delays Jackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership. About The FDA Group: The FDA Group helps life science organizations rapidly access the industry’s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/