Outsourcing Facility Compounding - Webinar Recording/Transcript

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In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.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

  • Executive suite
  • Strategic planners
  • Regulatory affairs
  • Quality affairs
  • Manufacturing executives
  • Legal counsel

Lee H. Rosebush, partner at Baker Hostetler and chairman of the Outsourcing Facilities Association
With a background as a defense, regulatory, and registered patent attorney who has also worked as a registered pharmacist, Lee Rosebush provides his clients with legal counsel that is grounded in first-hand experience. Whether his clients are confronted with legal issues related to the naming of a drug, clinical trials, marketing, promotions, or advertising, Lee possesses a strong understanding of the pharmaceutical industry which, combined with his attention to detail and experience working with biologics, medical device, and healthcare companies, gives clients a single source for regulatory and litigation counsel.