Delivering Personalized Medicine and Helping Mitigate Drug Shortages: The 503B Outsourcing Story

A new future is around the corner for quality metrics, tackling quality challenges, and collaborating with the FDA during the COVID pandemic. To prepare for this future, it’s time to expand our knowledge and perhaps learn something entirely new about quality in the pharma industry. 

Download our previous webinar and take a dive into the background of the 503B outsourcing facilities. Learn how they are embracing the challenges of our industry while becoming compliance-driven and taking a higher focus on patient safety.

FDA has been publishing more quality and safety guidance for this sector. With the models Govzilla has created, you’ll get a visual of the breakdown of warning letters and citations comparing the different challenges 503B compounding and drug facilities face—spotting issues hiding in plain sight. 

On Thursday, July 30, Jason McGuire, Global Quality Director at Fagron, and Jerry Chapman, Govzilla Senior GMP Quality Expert presented this informative webinar with Govzilla on 503B outsourcing and how they deliver personalized medicine and mitigate drug shortages. 

Download for the webinar here!

What you will learn:

  • What a pharma industry Section 503B outsourcing facility is

  • The role they play in producing personalized medicine products

  • How they help mitigate drug shortages

  • How they are partnering with industry to provide higher quality clinical trial materials

  • A novel application of machine learning with enforcement documents

  • How an AI tool can analyze an FDA warning letter and provide additional insight

Who Will Benefit? 

This session will be valuable to 503B quality and operations personnel, Directors of Pharmacy and surgery centers, purchasers, and anyone with an interest in personalized medicines or mitigating drug shortages in FDA-regulated industries.

To download, click here!

About the Presenters

Jason McGuire is currently the Global Quality Director for Fagron, an international company focused on personalized medicine. He has spent the last several years supporting the 503B Outsourcing Facility industry providing technical and regulatory guidance. Jason has nearly 20 years in the healthcare industry serving in many roles with a particular focus on Quality Control Operations, Quality Assurance, and regulatory support. He is a microbiologist by education and expertise where he spent time developing anaerobic microbial catalysts for fuel ethanol production.

Jerry Chapman is a Senior GMP Quality Expert at Govzilla. He writes the Govzilla blog “Conference Spotlight” and is working on machine learning models for analysis of agency enforcement documents. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.

At Lilly and again at Elanco, Jerry designed and implemented a comprehensive GMP Intelligence process—a process to identify pertinent GMP regulations and guidance, inspection findings, trends, and best practices, then analyze, communicate, manage and archive that knowledge to help ensure the company remained compliant with GMPs and regulatory agency expectations.

Prior to joining Govzilla, he was Chief Information Officer and Senior Editor at International Pharmaceutical Quality for six years as well as Editor in Chief for Xavier Health, covering their pharma and artificial intelligence conferences and publishing reports, primarily in Pharmaceutical Online. He was the founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010.

To download, click here! 

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