Michelle Hernandez

Company: Merck & Co

Job title: Director Occupational Toxicology

Seminars:

8:30-10:30

Workshop A

Examining the Viability of Process-Specific Analysis Replacing Control Banding to Avoid Over- Engineering & Maximize Cost-Effectiveness 8:30 am

Control banding has long been a critical element of process development for highly potent drugs. However, as potency increases and containment requirements increase, could a process-specific approach drive costs down and improve process safety? Topics include: Uncovering how the current banding structure can lead to overengineering Assessing process-specific methods to determine the API’s handling level…Read more

day: Workshop A

Panel Discussion: Assessing the Current State of Play for Highly Potent Development and Manufacturing & Overcoming the “New Normal 9:00 am

Delving into the key challenges that arise in highly potent development and manufacturing from process design considerations to occupational health Understanding where the gaps lie in effective assessment of hazard and how to combat this with effective controls  Ensuring scale-up occurs in a timely mannerRead more

day: Conference Day One