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Home » Store » Webinar Recordings » Outsourcing Facility Compounding - Webinar Recording/Transcript

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Audio Recording/Transcript - Feb. 19, 2019

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Outsourcing Facility Compounding - Webinar Recording/Transcript

$287.00
Webinar Recordings

Product Details

Outsourcing Facility Compounding: New Guidance for Outsourcing Facilities

In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.

How will these new requirements affect you?

Lee H. Rosebush — partner at Baker Hostetler and chairman of the Outsourcing Facilities Association — will address the newly proposed standards and will discuss several outstanding questions the industry must confront. After 90-minutes of discussion you’ll understand how to:

  • Comply with the nuances of the revised guidance — including the new line drawn between sterile and non-sterile drug products
  • Implement best practices to protect against contamination   
  • Comply with the guidance while making it feasible for outsourcing facilities to fulfill requests for office stock and maintain product quality
  • Ensure that a compounder’s quality control conducts sterility assurance activities for sterile products and microbiological quality activities for non-sterile products
  • Conduct annual quality standard evaluations of drug products
  • Comply with FDA evaluation requirements
  • Comply with revisions on release testing, reserve samples, the definition of “in-use time”, the use of third party laboratories for testing purposes and stability testing
  • Understand issues left unresolved by the guidance

This presentation will help you understand the new requirements presented by the revised guidance and how to comply with them.

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