Radiopharmaceutical Compliance & Risk Management| Isotope to Injection

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Radiopharmaceutical manufacturers face a complex landscape of regulatory, operational, and technical challenges. From managing radiation safety and contamination risks to navigating short shelf-lives and accelerated release protocols, every step in the development process demands precision and compliance. The need to balance sterility, speed-to-market, and evolving GMP expectations—especially under the lens of Annex 1 revisions—places added pressure on teams working with highly sensitive isotopes.

As companies scale from early development to commercial readiness, ensuring robust contamination control, aseptic processing, and reliable quality systems becomes critical. This webinar will explore how strategic choices in equipment, materials, processes, and packaging can help radiopharmaceutical developers overcome these hurdles and maintain compliance without compromising efficiency.

Key Learning Objectives

  1. Understand the unique contamination and sterility risks in radiopharmaceutical environments
  2. Learn how to balance speed-to-market with regulatory compliance
  3. Discover how to build scalable, risk-resilient systems that proactively manage extractables, particulates and container closure integrity

Aubrey Jeter

Aubrey Jeter

Technical Account Specialist, West Pharmaceutical Services

Aubrey Jeter is a member of the North American Technical Customer Support team with West Pharmaceutical Services. In this role, Jeter addresses technical questions and concerns regarding West products and processes, including making primary injectable packaging recommendations to align with the customer’s requirements for quality and safety. Jeter supports multi-national customers in various drug product spaces, including cell and gene therapies, advanced biologics, and small and large molecule therapies. Jeter graduated from Pennsylvania State University with a degree in Animal Science.
Lake Wooten, Ph.D.

Lake Wooten, Ph.D.

Project Manager, OrchestraLife Sciences

Lake Wooten, Ph.D. is an expert in medical isotopes and GMP manufacturing of radiopharmaceuticals. With 12 years of experience, Lake has worked on projects for several important therapeutic isotopes. Lake has helped establish 3 new radioligand therapy manufacturing facilities and lead high-impact projects as a Site Director and as a Sr. Scientific Project Manager. His leadership has encompassed isotope production, radiochemistry, GMP manufacturing/QC, technology transfer, project management, and radiation safety. Lake has been an Radiation Safety Officer and an Authorized User on U.S. Nuclear Regulatory Commission licenses. Lake has authored 17 publications and has earned five engineering degrees, including a Ph.D. in Biomedical Engineering. A dedicated advocate for radiopharmaceuticals, Lake is an Ambassador for Oncidium Foundation and Affiliate Faculty at the Purdue University College of Pharmacy.
Jason Mercer

Jason Mercer, Ph.D.

Strategic Program Champion, Facet Life Sciences

Dr. Jason Mercer, Strategic Program Champion with Facet Life Sciences, has more than 16 years of regulatory affairs experience guiding small and mid-sized pharma and biotech companies through the complexities of drug and biologic development. He is known for designing innovative, efficient strategies that help sponsors overcome regulatory challenges and accelerate timelines while maintaining compliance. With broad experience spanning CMC, clinical, and nonclinical regulatory support across diverse therapeutic areas and product types, Jason helps development teams achieve successful outcomes from early development through approval.