Managing Quality and Compliance Operations in an Accelerating Scientific Landscape

Managing Quality and Compliance Operations in an Accelerating Scientific Landscape

Description:

This webinar covers several important issues facing biopharmaceutical leadership today, especially those working in the rapidly growing cell and gene therapy space. Additionally, limited resources because of COVID-19 have also ushered in a new way of conducting business in drug development. For example, many drug development operations (e.g., upstream, downstream, clinical, and analytical) are relying more on automation and much more attention is being paid to ensuring quality. As the Life Sciences industry continues to help patients across the world, creating peak laboratory performance is a key component to addressing the new challenges within the industry.

Four key elements that will be discussed in this webinar are (1) managing outsourcing while maintaining the highest quality and compliance, (2) integrating the different mindsets from R&D to quality and compliance, (3) assuring quality and compliance with limited resources, and (4) making cost effective choices when investing in automation for the quality operation.

Learning Objectives:

Attendees will learn about (1) managing outsourcing while maintaining quality and (2) improving operational efficiency through automation.

Speakers:

Kat MacDonald

Kay McDonald, BS Microbiology

Ms. McDonald is currently the Senior Director of Quality Control at Generation bio. Her previous roles encompassing over 30 years in biopharma include Director of Quality Control at Seres Therapeutics, Takeda (formerly Shire), Acceleron Pharma, Lonza and the AD of ASAT at Alexion. In addition to product release, environmental control and stability testing, Ms. McDonald’s experience includes method development, facility and method validation. Her tenure in the industry spans a wide variety of therapeutic products such as antibodies, microbiome and enzymatic drugs for rare diseases.

Dr. Nat Hentz

Nathaniel Hentz, Ph.D.

Dr. Nathaniel Hentz is currently Director, Scientific Market Development at Artel. Prior to that, Dr. Hentz served as Assistant Director of the BTEC Analytical Lab at North Carolina State University for almost 11 years. In that role, he taught both undergraduate and graduate level courses as well as industry short courses focused on biopharmaceutical assay development and validation. Dr. Hentz’s tenure in the HTS industry includes nearly two years supporting the automated screening systems within the Lead Discovery group at Bristol-Myers Squibb in Connecticut and seven years developing screens at Eli Lilly RTP Laboratories in North Carolina.