Tami Frederick
Senior Director, Global Quality Compliance, Systems and Data Analytics, PerrigoTami is Senior Director of Corporate Quality Compliance, Systems, and Data Analytics. She the Chair of ISPE's Advancing Pharmaceutical Quality team. Tami is a co-author of the 2022 ISPE APQ Series, Quality Management Maturity Program five guide series. Tami led the PDA/ISPE Culture Collaboration team authoring the Root Cause Analysis Guide in 2019 and co-authored ISPE Cultural Excellence report in 2017. She is a member of the ISPE Regulatory Steering Team.
Tami is Global Quality Leader with 30 years of experience in the Pharmaceutical Industry. She is a chemical engineer by trade and cultural excellence consultant. Tami has held positions in Corporate Quality, QA & QC Operations, Data Analytics and QMR, Regulatory Affairs, R&D, Operational Excellence, and Technical Engineering. She is a certified Lean Six-Sigma Blackbelt and a Certified Quality Engineer. She is also HACCP certified and a Safe Quality Food Practitioner. Her experience spans solid, semi-solid, and liquid drug dosage forms, API’s, Medical Device, and Infant Formula/Foods. Tami has led multicultural Quality teams in the implementation of global quality systems such as global change control, EDMS, SQM, quality investigation and CAPA, corporate quality metrics & governance, global technology councils, and auditing to support compliance. She is a strategic, global continuous improvement leader and change agent advancing the culture of quality throughout all levels in the organization.
Michael Grischeau
Director of Data Analytics & Management Review, AbbVie IncMichael Grischeau is the Director of Data Analytics and Management Review at AbbVie. He is the current co-chair of the Management Responsibilities sub-committee for ISPE's Advancing Pharmaceutical Quality program.
Michael has over 20 years in the Pharmaceutical and Medical Device industry. His professional experience includes ownership of Management Review processes and global analytics teams that provide strategic insights on quality system health, product data, and site performance across global manufacturing networks. He is currently leading the ongoing redesign of AbbVie's quality management approach to data analytics, incorporating a modernized set of metrics for quality systems and compliance. He is driving automation of processes to ensure they are efficient, easily accessible, and user friendly to enable high impact, cross functional decision making along AbbVie’s product value chain.