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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In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.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:
This presentation will help you understand the new requirements presented by the revised guidance and how to comply with them.
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.
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