Life Sciences GxP Training From a Regulatory Perspective

Onboarding new employees and upskilling existing ones on Standard Operating Procedures (SOP) and Current Good Manufacturing Practice (cGMP) is mandatory to ensure personnel involved in pharmaceutical drug product manufacturing learn and adhere to the GxP procedures.

In a regulated industry so inherently regulated by regulatory agencies, life science companies often take particular care of personnel training to ensure safety and efficacy of drug products as well as to comply with the cGMP guidelines for training as stipulated by regulatory agencies.

About the presenter

Mark Lee, head of Research, Analytics and Business Development for ComplianceWire^® by UL Solutions

Lee, who holds a doctorate from the Georgia Institute of Technology, is an expert in human performance, learning and cognition with more than 15 years in the pharmaceutical and medical device industries. He is also an adjunct professor at New York University's Tandon School of Engineering in the Technology Management and Innovation department, teaching courses on managing HR technology and people analytics. A human factors engineer with experience in pharmaceutical development, Lee has 10 years' experience in GxP training and more than 30 publications on a variety of topics, mostly centered on learning and skill development.

• Ten years’ experience in GxP training
• More than 30 publications on a variety of topics, mostly centered on learning and skill development
• Human factors engineer
• Pharmaceutical development