The FDA’s Compounding Quality Center of Excellence exists to improve the quality of compounded drugs in order to promote patient safety by engaging and collaborating with outsourcing facilities, compounders and other stakeholders. Patient safety is the shared responsibility of FDA, state regulators, pharmacy associations and compounders ,including outsourcing facilities.
“The panel is a collaboration amongst 503B industry leaders with different business models. This particular group will be able provide an opportunity to share insights into the 503B Outsourcing Facility industry particularly on current practices and an outlook for the future,” said Jason McGuire, Fagron Global Quality Director.
The Center of Excellence will host its virtual conference for current and future outsourcing facilities, regulators, and other compounding experts. Stakeholders can collaborate on key topics and best practices.
Fagron Quality Directors to participate in 503B Panel Discussion
We are pleased to announce Fagron’s Global Quality Director, Jason McGuire, and Quality Assurance Director, Josh Parks, will participate as panelists at 2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality. Quality is one of the core values at Fagron Sterile Services. Jason and Josh have played a key role in developing quality centric and customer focused culture at Fagron Sterile Services.
“When you establish a culture of quality in an organization you create a sense of ownership for every employee. Therefore, from start to finish every person feels responsible and accountable to ensure the finished product meets the highest standards and every requirement before leaving the facility,” Jason said.
Jason will be part of the Cross-Sector Panel discussion on Outsourcing Facilities and Purchasers. Participants will have an opportunity to listen in to perspectives from a panel of outsourcing facilities, health-systems, GPOs and physician specialty groups as they discuss opportunities and challenges for outsourcing facilities, including Fagron Sterile Services, and their supply chain and healthcare partners. The panel will focus on the purchaser environment and how they exist in the ecosystem and how that influences Outsourcing Facilities. This session will be held in the format of a moderated panel, and the questions for the panel will be structured and pre-planned.
Josh will participate in What to Expect on a 503B Inspection – From Initiation to Closeout and shared he is “looking forward to participating on this panel because it brings the FDA and industry leaders together to have a collaborative discussion that will help better prepare participants for an audit and then perform to meet the FDA's expectations.”
Josh’s panel discussion will take place on Tuesday, September 14 at 12:45 PM (EST) and Jason’s will take place on Wednesday, September 15 at 11:00 AM (EST). Access the full conference agenda here
Conference registration is free and includes access to an interactive platform as well live sessions and presentations. Click here to register.
Fagron Sterile Services US, a top-tier DEA and FDA-registered 503B Outsourcing Provider, produces reliable supply of high-quality sterile medications with cGMP compliant operations to patient-focused healthcare facilities across North America.
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