Zaheer Abdool

• Zack Abdool, is an Associate Director of Global Regulatory Affairs at Takeda. He is currently responsible for process improvement and metrics related to Takeda’s QMS Compliance activities within Global Regulatory Affairs Operations. In this role he engages internal global stakeholders on process improvements specific to Takeda’s regulatory processes. Zack joins Takeda from Amgen where he was most recently the Global Process Owner for Quality Risk Management in Corporate Quality. He oversaw the strategic and tactical aspects of Quality Risk Management for Amgen’s Pharmaceuticals, Combination Products, and Software as a Medical Device portfolio. Zack ensured Amgen’s process implementation of QRM/RM included requirements from CFRs, MDR, ISO 14971:2019 and ICH Q9 (R1). He has also had roles in Amgen’s Combination Product Quality Development Organization where his emphasis was on process enhancement related to Design Control Process optimization, Human Factors, and supported more robust requirements definitions for early-stage device candidates. Zack started his career in Quality Engineering and has supported various areas within Medical Device/Combination Product Development and Manufacturing. His previous experience includes roles at Becton Dickinson, Boston Scientific, Medtronic, Covidien and Smith & Nephew prior to joining Amgen. He has a BS in Mechanical Engineering from Wentworth Institute of Technology.
Speaking In
11:00 AM - 12:00 PM
Tuesday, June 6
This session will engage an expert panel in a discussion on a number of timely regulatory policy…