Outsourcing Facility Compounding
New Guidance for Outsourcing Facilities

Tuesday, Feb. 19, 2019 · 1:30 p.m. - 3:00 p.m. EST

In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.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

Who Will Benefit

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

Webinar plus Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus Audio Recording/Transcript
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$487

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24/7 Encore Presentation
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$287

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Audio Recording/Transcript
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$287

add to cart

 

 

 

Meet Your Presenter

Lee H. Rosebush

Partner
Baker Hostetler

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. Lee Rosebush is chairman of the Outsourcing Facilities Association.

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