Evaluating the Hazards of Pharmaceuticals: Quantitative Product Safety Assessments (PDEs, ADEs, HBELs)

In this 1.5 hour intermediate to advanced discussion on the current methodologies available for the development of HBELs to establish acceptable levels of cross-contamination during manufacturing. In addition to assessing the hazards of cross-contaminating one drug substance with another, we will also cover other impurities identified in products that may be administered to patients. These include process impurities, residual solvents, degradants, adulterations, and extractable and leachable compounds. Sample data sets and compound-specific examples will be reviewed. Quantitative Occupational Assessment webinar is a pre-requisite.

Who Should Attend
  • Pharmaceutical and chemical plant environmental health and safety professionals
  • Pharmaceutical R&D safety coordinators
  • Facility and process engineers
  • Industrial hygienists
  • Safety professionals
  • Environmental engineers
  • Pharmaceutical quality control and quality assurance personnel
  • Plant managers

About the Instructors

The webinars will be led by Bob Sussman, Ph.D., DABT, Tracy Kimmel, Ph.D., DABT and Elizabeth Vancza, Ph.D., DABT, SDSRP of SafeBridge Consultants, Inc., the premier occupational health and safety consulting firm to the bio- and pharmaceutical industries, especially with regard to potent compounds. Each pharmaceutical occupational toxicology and industrial hygiene experience in the systematic and scientific approach to safe handling of potent active pharmaceutical ingredients and drug products.

Note: The course fee is per attendee. Recording the training course is strictly prohibited.

For registration questions please contact Kent Rader at Kent.Rader@safebridge.com

Webinar topics

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Oct 15, 2020 -- Online
9:00 AM Eastern time
Oct 15, 2020 -- Online
2:00 PM Eastern time