Webinar Series: Evaluating the Hazards of Pharmaceuticals

This series of webinars provides varying levels of detail into the evaluation of the potential health hazards related to exposure to pharmaceutical substances. Sign up for all 4 webinars at the reduced pricing with one single registration.

Evaluating the Hazards of Pharmaceuticals: Basic Concepts. An introductory level discussion around the data that are available for active pharmaceutical ingredients vs. commodity chemicals. It will include introductory discussions on the various qualitative and quantitative methods available for hazard assessment, how they are used to evaluate the potential hazards of workplace exposure. These include Occupational Exposure Bands (OEBs), Occupational Exposure Limits (OELs), Acceptable Surface Limits (ASLs), Permitted/Acceptable Daily exposures (PDEs/ADEs), and other assessments. Detailed instruction on the derivation of these values is covered in the subsequent webinars.

Evaluating the Hazards of Pharmaceuticals: Quantitative Occupational Assessments (OELs & ASLs). An intermediate to advanced discussion of setting OELs including selection of points of departure, selection of adjustment factors, pharmacokinetic variability (including bioavailability), interspecies adjustment, and what to do with limited data sets. We will focus on exposure to pharmaceutical compounds and will discuss how the data should be interpreted and applies specifically for occupational scenarios. Sample data sets and compound-specific examples will be reviewed.

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

Evaluating the Hazards of Pharmaceuticals: Qualitative Occupational Assessments (OEBs & OHCs) An intermediate to advanced level discussion on the qualitative assessment of pharmaceutical compounds including: the history of OEBs, developing an enrolment criteria matrix, and why it is important to linking these bands to a control matrix. We will also discuss how banding systems have been used and misused over the years. Sample data sets and compound-specific examples will be reviewed.

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


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