2026 - June ASQ Orange Empire, Section 0701, Monthly Meeting

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This presentation will cover an overview of cGMP pharmaceutical and QMSR medical device FDA inspection processes, MDSAP and ISO 13485 audits, best practices in managing an inspection and audit, and how to respond to FDA 483s, Warning Letters, and audit list of non-conformities

Kim Walker is an independent Global Regulatory Affairs, Quality System, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, and start-up to large company environments. Recently, she assisted the World Health Organization (WHO) as an Innovation COVID-19 Response Team Consultant and Operations Support & Logistics Supply Team Consultant, where she evaluated regulatory and quality system preparedness for COVID-19 medical devices and IVDs for WHO placement in underserved countries.

Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. Additionally, she served on the OCRA Board of Directors 2004-2010 and 2019 and was the 2008-2009 President. She has participated in the San Diego Regulatory Affairs Network (SDRAN) Mentoring Program since 2009, has served on the Board of Directors since 2023, and is the 2024 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics.

Kim participated on the California State University Program for Education and Research in Biotechnology (CSUPERB) Advisory Committee and Development Team for the “Project Management in Clinical Trials” certificate program through California State University, Fullerton (CSUF). She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course. Kim was also an instructor or the “Regulatory Requirements for Pharmaceutical Products” and a co-instructor for the “Technical Writing for the Medical Product Industry” courses at the University of California Irvine Extension. She re-developed and currently teaches the “Medical Device Regulations,” “Regulatory Intelligence and Strategy,” and “International Regulatory Affairs” courses for the San Diego State University (SDSU) Master of Science in Regulatory Affairs program. Kim is the Faculty Director and Graduate Advisor for the SDSU Regulatory Sciences Center. Kim developed and taught an undergraduate “Medical Product Regulations: Bench to Bedside” course at CSUF with a focus on stem cell therapies, through a California Institute for Regenerative Medicine grant program. She developed and currently teaches the “Introduction to Regulatory Affairs” course at Roseman University’s College of Graduate Studies.

She achieved both the US and EU Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certifications and has been accepted as a RAPS Fellow in recognition of her leadership in advancing the regulatory profession. Additionally, Kim received the 2008 RAPS Leonard Stauffer Award in recognition of her contributions to mentoring and furthering regulatory education development. She received a Leveraging Collaboration Award from the FDA for being the industry originator of the LOS-DO Quality Leadership Network (QLN), helping to bridge communication and collaboration opportunities between FDA and industry. Kim received a lifetime membership award from OCRA in 2017 and SDRAN in 2022. She has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.

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