PDA Southern California Chapter and OCRA Joint Webinar: The New Paradigm: “Inspections During COVID”

Kimberley Buytaert-Hoefen, PhD, Director of Pre-Clinical Consulting of Azzur Group  has 20 years of experience in research and development (7 years) commercial pharmaceutical, gene and cellular therapy and medical device industry involvement (13 years).  Currently, she works closely with gene and cellular therapy companies to develop and implement effective regulatory compliance solutions. Specifically, Buytaert-Hoefen’s experiences include

1. cGMP Manufacturing site assessments for FDA 21 CFR Parts 11, 210 and 211 and Q7A.
2. Clinical site assessments for multiple cell collection, processing and infusion sites.
3. Regulatory preparations including INTERACT and BLA FDA submissions.

Buytaert-Hoefen’s has developed an expertise in performing pharmaceutical and medical device inspections with an emphasis on sterile processing.  She was a former FDA investigator trained at performing surveillance, for cause, pre-approval establishment and post-marketing adverse drug experience reporting inspections.  Buytaert-Hoefen is highly skilled at laboratory data review both in chemistry and microbiology, data integrity assessments, and process validation.  She is qualified in the authoring, review and coordination of regulatory documentation.

Ms. Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in Drugs, Biologics, Medical Devices, Healthcare & Food sciences. Her expertise combines GxP regulations in Quality Assurance, Regulatory Compliance, Clinical Trial Science, Auditing, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers/clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers, Veracyte and other Medical Device Companies, Stanford Hospital & Baylor College of Medicine. She consults with pharma, biotech, medical device, and food companies, thereby provides due diligence for investors. Past Positions include Chief Compliance Officer, Director of QA, and MIS Director.  She also co-authored & prototyped 21 CFR 11 guidance with FDA and commented on GAMP5 and FDA guidance documents. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance. Quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for the Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Adjunct Professor at UC Berkeley. Vice President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

Karine Lux serves as the Senior Manager, Quality Systems Initiatives, focusing on leading and facilitating measurable operational and process improvement projects with a quality focus. Karine joined The Jackson Laboratory in 2003, focusing on and obtaining AAALACi accreditation and OLAW assurance for the (then) new Sacramento site. During her tenure at JAX, Karine held multiple roles in addition to the Quality position, including In Vivo Research Services Manager (outsourced nonclinical services), interim Environmental Health and Safety Services Manager, and IACUC Chair. Before joining The Jackson Laboratory, Karine gained her management, operational, research, and regulatory experience with management and research positions at Scios, Inc, ALZA Corporation, and In-Vivo Technologies, Inc.  Moreover, Karine holds a Bachelor of Science degree in Animal Science from the University of California at Davis and is LAT certified.

Aaron Rose serves as the Senior Program Manager for The Jackson Laboratory Invivo Services. His role focuses on customer experience, strategic product management, and sales analysis. Aaron joined The Jackson Laboratory in 2015 as a technical information scientist focused on helping researchers understand and find the right mice for their scientific needs. He has also served as a project scientist and study director in In Vivo Services. Before joining The Jackson Laboratory, Aaron worked as a post-doctoral researcher. He co-founded a biotech, Biologic Hawaii Inc. Aaron holds Bachelors degrees in Chemistry and Molecular Biology from Humboldt State University and a Ph.D. in Molecular Biology from The University of Hawaii at Manoa.