2024 Speakers

Jennifer Ahearn, GMPACT

Ms. Jennifer Ahearn specializes in FDA regulated product compliance.  She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations relating to FDA regulated product quality and manufacturing. Ms. Ahearn has assisted pharmaceutical, medical device, combination product and dietary supplement companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection and performed holistic site remediations. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms, OTC products, medical devices, combination products and dietary supplements.

Blake Bevill, Program Division Director

Division 2, Office of Medical Device and Radiological Health Operations

Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections. He accepted a Supervisory Investigator position in 2001. Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives. He became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014. He is currently the Program Division Director for Division 2 Central within the Office of Medical Device and Radiological Health Operations. As the Director of Division 2 Central, he leads all device inspectional and compliance activities that formerly resided in the seven District Offices of ATL-DO, CHI-DO, FLA-DO, KAN-DO, MIN-DO, NOL-DO, and SJN-DO. He graduated from Harding University with a Bachelor’s degree in Biology, Arkansas State University with a Master’s of Science degree in Biology, and completed a Senior Executive Development program at George Washington University.

Karen M. Cruz, U.S. Food and Drug Administration

Senior Operations Officer

Karen M. Cruz joined the FDA in October 2010.  She is a Senior Operations Officer with the Office of Medical Device and Radiological Health based out of the Tampa office. She has performed a variety of fieldwork domestically and internationally and has completed multiple details as Supervisory Investigator and Compliance Officer. She is also member of the Course Advisory Group for two medical device courses and conducts trainings at a division and national level.

She obtained the Level II Medical Device Investigator Certification in October 2018 and has received two Outstanding Service Awards in her career with the FDA.

Prior to joining the FDA, she worked nine years as a Microbiologist and Senior Microbiologist at two global pharmaceutical and medical device companies. Ms. Cruz obtained a Bachelor of Science Degree of Microbiology and Molecular Biology from the University of Central Florida, Orlando, FL in 2001.

Maida Henesian, U.S. Food and Drug Administration

Certified Medical Device Investigator

Maida Henesian is a Certified Medical Device Investigator with the Office of Medical Device and Radiological Health Operations (OMDRHO), Division 3, Group 6, and has worked for the FDA since 2002. In her role as a Medical Device Investigator, Maida has conducted 203 medical device inspections since 2007 in every device compliance program, including both domestic and foreign inspections, provided training to FDA new hires, and given public speaking to private and regulatory groups. Maida holds a BS in Pharmacy and an MS in Health Services Administration.

Carter McCain, Axogen Inc.

Carter McCain is the Director of Quality Systems Compliance for Axogen, a leading company providing surgical solutions for peripheral nerve repair. He has nearly a decade of experience in the pharmaceutical and medical device industries, with extensive leadership in the design, development, implementation, and improvement of enterprise quality systems. Carter has been with Axogen for three years, and worked in quality systems management in Thermo Fisher Scientific’s cell and gene therapy business unit prior to joining Axogen. He and his wife Karen have three sons: Samuel, Joel, and Aaron. In his spare time, Carter enjoys watching football (Go Jags!), playing chess, and introducing people to the joys of whiskey tasting.

Salvatore (Sal) Randazzo, U.S. Food and Drug Administration

Salvatore (Sal) Randazzo joined the FDA, Office of Regulatory Affairs (ORA), Florida District Office in 2002, as part of a new hire initiative following September 11, 2001. As an Investigator in Florida District, Sal specialized in the medical device and drug program areas where he conducted complex inspections involving high-risk products and processes. In 2009, he joined the Florida District Compliance Branch as a Compliance Officer processing cases involving medical device and drug manufacturers that were found non-compliant with Agency-enforced laws and regulations. In 2017, following ORA’s program alignment, he continued his work as a Compliance Officer in the Office of Medical Devices and Radiological Health Operations, Division 2 – Central, Compliance Branch.  Sal also serves as Technical Expert for FDA’s AAMI Standards Workgroup 1, Industrial EO Sterilization..

Kim Trautman, Managing Director of Trautman International Services

Medical Device, IVD and Combination Product Expert

Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 40 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master’s Degree in Biomedical Engineering.

Kim Walker, Global Regulatory, Quality, and Clinical Consultant

Consulting Work: 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.

Academic Work: Kim is the current Faculty Director and Graduate Advisor for the San Diego State University (SDSU)  Center for Regulatory Sciences.  She re-developed and currently teaches the “Medical Device Regulations,” “Regulatory Intelligence and Strategy,” “In Vitro Diagnostic (IVD) Regulations,” and “International Regulatory Affairs” courses for the SDSU Master of Science in Regulatory Affairs program.  She developed and currently teaches the “Introduction to Regulatory Affairs” course at Roseman University’s College of Graduate Studies.  Additionally, she 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.  She 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 (CIRM) grant program.  Kim was also an instructor for 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.