Partner at Validant
Validant
Janet Michener Whipple is a Partner at Validant, specializing in Medical Devices, Invitro-Diagnostics and Combination Products. Based in Southern California, Jan has a comprehensive background in Quality, Regulatory Compliance, Product Design, Supply Chain Operations, and Project Management.
Prior to becoming a Partner at Validant, Jan was a Validant consultant where responsibilities included leading acquisition integrations and divestitures, tech transfers and plant closures, preparation for audits and inspections, quality management system design and remediation, project management for New Product Introductions and product rebranding, implementation of ISO 14971:2012, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP), as well as preparation for the European Union Medical Device and Invitro-Diagnostic Regulations (EU MDR and IVDR). Prior to Validant, Jan held various roles at Beckman Coulter.
Jan received her Bachelor of Science degree in Mechanical Engineering from California State Polytechnic University, Pomona and her Masters of Business Administration from California State University, Fullerton. In addition, she is a Licensed Professional Mechanical Engineer. Areas of expertise include Quality System design, implementation, and remediation; Regulatory Intelligence; Project Management; Audits, Inspections and Due Diligence; as well as Warning Letter management/remediation.
Sunday, September 22
8:00 AM – 4:00 PM
Monday, September 23
12:15 PM – 12:45 PM
Monday, September 23
3:15 PM – 3:45 PM