What: From Risk to Resilience: Building a Modern Contamination Control Strategy Under EU GMP Annex 1
Building a modern contamination control strategy (CCS) under the revised EU GMP Annex 1 involves a shift from reactive measures to a holistic, proactive, and risk-based approach, emphasizing Quality Risk Management (QRM) principles and continuous improvement. The strategy must be a single, living document that integrates all elements of contamination prevention, detection, and control across the entire product lifecycle. We will delve into the key components of the CCS, including facility & process design, quality risk management, and environmental & process monitoring. As well as how to implement a robust and compliant contamination control strategy in alignment with the revisions to EU GMP Annex 1.
Who: Krysten Scull, Principal Scientist of Microbiology, Johnson & Johnson
Krysten Scull is the Principal Scientist of Microbiology for Johnson & Johnson’s Innovative Medicine greenfield biotherapeutics site in Wilson, NC. She is a diversified pharmaceutical scientist with 14+ years of experience spanning early development to supply chain. She has deep expertise in cGMP quality & compliance (including FDA, EMEA, ISO, & USP regulations and requirements), risk assessment, Environmental Monitoring program design, contamination control strategies, and aseptic techniques.
Krysten has supported several facility and laboratory start-ups including leading the method transfer of three ELISA based immunoassays, the initial validation and qualification of a cell & gene therapy pilot plant facility, and various analytical method transfers for two autologous CAR-T therapies. In her current role, she is leading the start-up of the QC Microbiology laboratory, supporting the initiation of the site contamination control program, and providing quality and microbiological oversight and guidance to the detailed design, construction and qualification phases of a new facility ensuring best practices and regulatory guidance’s are applied.
Please use the link to register no later than 1:00pm on Wednesday, December 3, 2025
Registration is free and donations are accepted.