FDAnews Announces -- Outsourcing Facility Compounding: New Guidance for Outsourcing Facilities Webinar, Feb. 19, 2019
Game-changing revisions to GMPs set new standards for outsourcing facility compounding outsourcing facilities. Get expert guidance.
FALLS CHURCH, Va., Feb. 5, 2019 /PRNewswire-PRWeb/ -- Learn what the commenters said and what the FDA has planned for outsourcing facilities and the industry.
Plan to join February 19 when 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 attendees understand the new requirements presented by the revised guidance and how to comply with them.
Meet Your Presenter:
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.
Who Will Benefit:
- Executive suite
- Strategic planners
- Regulatory affairs
- Quality affairs
- Manufacturing executives
- Legal counsel
Webinar Details:
Outsourcing Facility Compounding
New Guidance for Outsourcing Facilities
**An FDAnews Webinar**
Tuesday, Feb. 19, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/outsourcingfacilitycompounding
The comment deadline for the draft guidance Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (Dec. 2018) is February 11, 2019.
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/outsourcingfacilitycompounding
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
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