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.
The course will be geared to:
- Drug Innovators (small to large pharmaceutical companies)
- Contract Manufacturing and Development Organizations (CMOs and CDMOs)
- Contract Research Organizations (CROs)
- Vendors (equipment and containment manufacturers, safety suppliers, architects and engineering design firms and other support services)
Who should attend:
- Business Development
- R&D and Manufacturing Management
- Project and Facility Management
- Mergers & Acquisitions
- Chemistry Manufacturing and Controls (CMC) leadership and team members
- Regulatory Affairs and Quality Assurance
- Other job functions that support potent compound facilities
(Additional courses recommended for engineering, toxicology and industrial hygiene and safety personnel include the SafeBridge Potent Compound Safety Boot Camps I and II and "Industrial Hygiene for the BioPharmaceutical Industry" (coming soon).
Your instructors will be board-certified health professionals in industrial hygiene and toxicology with many years of experience in the pharmaceutical industry. The presentations and material cover pharmaceutical industrial hygiene (IH), occupational toxicology, environmental toxicology and IH analytical chemistry. The agenda will include:
- Introduction to potent compounds – definitions
- Information needed to assess potent compounds
- Elements of a potent compound safety program
- Business advantages of comprehensive potent compound safety programs
- The regulatory aspects of potent compound safety R&D and manufacture
- cGMP regulatory change
- Status of requirements for segregation of cytotoxic, certain hormones and beta-lactams
- Potent compound safety elements for drug development templates
- Determining the health effects of potent compounds
- Controls by process step for chemical and pharmaceutical drug product facilities
- Laboratories/QC and R&D
- Industrial hygiene qualitative and quantitative exposure assessment
- Can my company or my CMO safely manufacture potent compounds?"
- And much more, including scenarios to apply to your situation
$850 for the first attendee; $750 for each additional attendee from the same company
The above costs include Course Syllabus, meals (breakfast, lunch and breaks) and Certificate of Completion. Payments may be made by check, invoice, Visa, MasterCard or American Express. Your hotel room reservations must be booked directly with the hotels.
SEATING IS LIMITED AND OUR COURSES USUALLY SELL OUT! Please contact Catherine before making travel arrangements to ensure space is available. We look forward to seeing you there!