Simplifying Global Compliance
Outsourcing Facility Compounding - Webinar Recording/Transcript
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Outsourcing Facility Compounding: New Guidance for Outsourcing Facilities
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In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.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.
