Kim Walker Consulting
About Us
Kim Walker, MS, RAC (US & EU), FRAPS
Kim Walker, MS, RAC (US & EU), FRAPS is an independent Global Regulatory, Quality, and Clinical Consultant. She opened Kim Walker Consulting in 2006. In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system issues. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.
Kim's Pre-Market Submission experience includes creating and negotiating 510(k), PMA, HDE, CLIA, IDE, Pre-IDE, IND, Pre-IND, BLA, ANDA, CE Mark Technical File/Dossier, Health Canada, and various other global regulatory submissions.
Kim’s Quality System auditing experience includes GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, and PAI audits.
Kim’s Clinical Trial experience includes creating protocols, investigator brochures, clinical management procedures, conducting GCP audits, writing and negotiating Pre-IND/IDEs, writing and negotiating IND/IDEs, and writing and negotiating various pre-market submissions containing clinical data. She has participated in and/or managed the following types of clinical studies: IVDs, medical devices, biologics, pharmaceutical, and combination products. Kim has extensive negotiation experience with the FDA and other global regulatory authorities.
Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. She taught at and managed the OCRA US RAC Study Group from 2004–2008 and the EU RAC Study Group 2004-2005. Kim was elected as the OCRA Annual Meeting Chair where she managed, moderated, and presented at the 2006 and 2007 2-day FDA-OCRA Annual Conferences with an average attendance of ~325 regulatory, quality, clinical, and government professionals. Additionally, she served on the OCRA Board of Directors 2004-2010 and 2019 and was the 2008-2009 President.
Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009.
Kim participated on the UC Irvine Extension Life Science Advisory Committee for three years. Additionally, Kim guest lectured for the CSULA “From Concept to Market” BIOL 454L and UCSD “Regulatory Strategies for Combination Products with Medical Devices” courses. She participated on the CSUPERB Advisory Committee, Development Team for the Project Management in Clinical Trials Certificate Program through the California State University system. She was the instructor for the BIOL 539 "Pre-Market Submission Process" and co-instructor for the BIOL 535 "Regulatory Requirements for Medical Products" class in the certificate program. Kim also co-created and has co-taught since 2016 an undergraduate course “Medical Product Regulations: Bench to Bedside” at CSUF with a focus on stem cell therapies.
Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at the University of California Irvine Extension. Currently, she teaches a "Medical Device Regulations" course for San Diego State University in their Master of Science in Regulatory Affairs program.
She achieved both the US and EU RAPS Regulatory Affairs Certifications. Kim received the 2008 Leonard Stauffer Award from RAPS and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession. Also, she received a Lifetime Membership from OCRA for her years of service to the organization.
Kim has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.
Professional Associations
- Regulatory Affairs Professionals Society (RAPS)
2008 Leonard Stauffer Award Winner
2016 RAPS Fellows Program (FRAPS)
Member Since 2002
- Orange County Regulatory Affairs Discussion Group (OCRA)
Awarded Lifetime Membership 2017
Board Member 2004 - 2010 & 2019
2008-2009 President
Program Committee Member Since 2003
Mentoring Program Committee Member 2012-2017
- San Diego Regulatory Affairs Network (SDRAN)
Mentoring Program Participant Since 2009
- Clinical Laboratory Standards Institute (CLSI)
Participant on Quality Management Systems, EP9, GP22, and Point of Care Testing Subcommittees 2009 - 2013
- CA State Univ. Program for Education and Research in Biotechnology (CSUPERB)
Participant on Project Management in Clinical Trials Certificate Program Advisory Committee and Development Team 2009 - 2013
BIOL 539 Pre-Market Submission Process Course Instructor
BIOL 535 Regulatory Requirements for Medical Product Course Co-Instructor
- San Diego Clinical Research Network (SDCRN)
Member since 2013
- LinkedIn Contact: http://www.linkedin.com/profile/view?id=27612925&trk=tab_pro
· 2008 Leonard Stauffer Award Winner
The Leonard Stauffer Award recognizes exceptional contributions to mentoring and furthering regulatory professional education development.
· 2016 RAPS Fellows (FRAPS) Recipient
The FRAPS program recognizes senior regulatory professionals for their significant contributions and leadership in advancing the regulatory profession and the Regulatory Affairs Professionals Society (RAPS).
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