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Virtual

22 jun 2021 9:30 a.m. - 22 jun 2021 12:30 p.m.

#021A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle

Instructors

Arun  Mathew, MSc

Arun Mathew, MSc

Associate Director, Abbvie, United States

Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.

Matt  Burtt, MBA

Matt Burtt, MBA

Director Clinical QA, AbbVie, United States

After completing a Biomedical Engineering undergraduate degree, I built upon my internship with Abbott (eventually AbbVie) in a 2 year rotational program with different assignments every six months across the business landscape. Since then I've been in the R&D Quality Assurance world, added an MBA and spent the last 6 years helping to build a "Program Management" team in GCP QA. We have aggressively sought opportunities to drive proactive QA in the Development / Clinical landscape via fully embracing the integrated Quality System approach. Our team members support all compounds/assets with a strategic Quality mindset. Critical thinking, Risk and Issue Management have led to successful submissions, inspections and approvals.

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