Webinar:

Critical Aspects of a Robust Highly Potent Compound Program

Sponsored by: CordenPharma

Focused on:

  • Highly Potent Compound
  • Containment
  • A P I
  • Contract Manufacturing
  • Manufacturing

Date: 4 April

51

Time: 8:00 MDT / 10:00 EDT / 15:00 BST / 16:00 CEST

The Importance of Understanding Intangible Elements of Containment

When handling highly potent compounds, protecting workers from exposure is both critical, but also extremely challenging. Unfortunately, installing containment devices is only one step to full containment. While a successful program obviously requires effective engineering controls, the most important (and often over-looked) aspect to a robust containment program is the strength of the intangible, softer elements. Without these supporting elements, even state-of-the-art containment equipment will not consistently and reliably contain highly potent compounds, leaving both the company and employees at risk.

CordenPharma’s API manufacturing facilities in Boulder, CO have over 30 years of experience successfully implementing innovative solutions to ensure containment of Highly Potent Active Pharmaceutical Ingredients (HPAPIs), designed to protect workers from the unique hazards presented by potent compound handling. This webinar will address five aspects of a robust highly potent compound containment program organized in what CordenPharma refers to as

The Containment Puzzle:

  • Engineering Controls
  • Containment Culture
  • Process Development
  • Occupational Health Pre-Planning
  • Containment Execution Cycle

A robust highly potent compound containment program recognizes that it takes an alignment of all of the pieces of the Containment Puzzle to ensure continued success, where there is no such thing as a “done stamp” on containment. Once containment is achieved, it must be periodically observed, critiqued and monitored, because operational qualifications are not just for the initial installation. Finally, once a system is qualified and respiratory protection is removed, Industrial Hygiene monitoring becomes even more critical and should be completed more often. Throughout the webinar, you will gain practical advice on how to apply these elements to your facility or containment program.

The integration of the hard elements of Engineering Controls and the soft elements of the Containment Puzzle has proven enhanced and repeatable containment for specific installations at CordenPharma, and is vital for the success of a robust Industrial Hygiene program.

Join us for this webinar to learn how to maximize the success of your engineering control investments by applying the intangible elements of the Containment Puzzle, allowing continued alignment to your company’s commitment to providing a workplace free of recognized health and safety hazards.


Presented by

Robin Livingston,

Environmental, Health & Safety Manager, CordenPharma Colorado

Robin Livingston has a Bachelor of Science degree in Chemical Engineering from the University of Notre Dame. She started working at the CordenPharma Colorado facility (then Roche) in 2001 as an Environmental Engineer.

She later expanded her role to become Environmental, Health, and Safety Manager, helping her team obtain SafeBridge Potent Compound Certification in 2013.

Key Learning Objectives

  • Learn the importance of understanding intangible soft elements of a robust potent compound program.
  • Hear a detailed explanation of each aspect of a strong highly potent compound program.
  • Plan for an on-going robust containment system, long after installation.
  • Learn practical ways to apply these elements to your company’s potent compound program.

Audience

  • EHS Managers
  • Health and Safety Professionals
  • Industrial Hygienists
  • CMC
  • Outsourcing
  • Manufacturing