Partner
Validant, United States
Janet Michener Whipple is a Partner at Validant, specializing in Medical Devices, In-vitro Diagnostics and Combination Products. With over 30 years of industry experience, Jan has a comprehensive background in global regulatory compliance, Quality, design, supply chain operations, post-market surveillance, audits and inspections, and regulatory intelligence. Jan has worked both strategically and in hands-on tactical roles with start-up organizations, mid-sized firms and large manufacturers within the top 20 global pharmaceutical and medical device firms.
Jan’s responsibilities have included QA leadership roles, warning letter response and remediation, due diligence and acquisition integrations, facility start-ups, product transfers and plant closures, quality management system design, harmonization and remediation, in addition to multiple quality system improvements, and preparation for new/revised regulatory requirements, including most recently 21 CFR Part 4 Combination Products, as well as preparation for the European Union Medical Device and In-vitro Diagnostic Regulations (EU MDR and IVDR).
Jan earned a Bachelor of Science in Mechanical Engineering and a Masters in Business Administration. She is a licensed Professional Engineer in the state of California. She is a Project Management Professional (PMP) and in addition holds several industry certifications such as Lead Auditor, Six Sigma Black Belt, and Manager of Quality/Organizational Excellence.
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Wednesday, May 10, 2023
08:30 – 16:00 CEST