Understanding Potent Compound Safety – A Primer for Non-EHS Professionals
This one-day course will provide important aspects needed to understand Potent Compound Safety for business and management roles related to R&D and manufacturing of potent active pharmaceutical ingredients (APIs) and drug products.
- Introduction to potent compounds
- Elements of a potent compound safety program/business advantages
- Regulatory aspects of potent compound safety R&D and manufacture
- cGMP regulatory changes
- Status of requirements for segregation of cytotoxic, certain hormones and beta-lactams
- Hazard assessment
- Measuring workplace exposure
- Relationships with third parties
- Industrial hygiene qualitative and quantitative exposure assessment
- "Can my company or my CMO safely manufacture potent compounds?"
Jun 14, 2018 -- Boston, MA
8:00 AM - 5:00 PM