Qualifying CMOs/CDMOs for the Safe Handling of Potent Compounds

Contract manufacturing (CMOs) and development organizations (CDMOs) are becoming the majority provider of potent APIs and drug products to the marketplace. Within the CMO/CDMO space, there are the “contenders”, those who understand both the hardware (containment and controls) and software (procedures, practices and programs) needed when handling potent compounds and the “pretenders”, those who believe they can safely handle these compounds, but don’t have the appropriate elements and systematic programs in place. This webinar will examine these issues from the perspective of the drug innovators as well as the CMOs/CDMOs. Topics covered will include:

  • Examples of what can go right and what can go wrong when taking on projects with potent APIs and drug products – what is needed from the drug innovator and also from the CMO/CDMO
  • Requirements and elements of a scientific and systematic program to support potent compound safety and quality assurance programs with potent APIs at CMOs/CDMOs and drug innovators.
  • Guidance on how to assess capabilities, both qualitatively and quantitatively and ways to verify the adequacy of containment, controls and work practices for the safety of workers and also to prevent cross-contamination, especially during times where site visits are limited or cannot be conducted due to COVID-19 restrictions.
  • Who Should Attend:

  • CMO and CDMO management
  • CMO and CDMO operations staff
  • CMC staff
  • Liaisons from the drug innovator to CMOs/CDMOs
  • Quality assurance
  • Business development
  • Industrial hygiene and EHS staff
  • Auditors
  • Engineering staff
  • Vendors providing containment and controls for potent compounds

  • Webinar topics

    Register now


    Mar 04, 2021 -- Online
    9:00 AM Eastern time
    Mar 04, 2021 -- Online
    2:00 PM Eastern time