Author
Walid El Azab
Attendees:
This interactive forum is essential for professionals navigating the practical challenges of maintaining sterility and controlling contamination. Key attendees include Microbiologists, Sterility Assurance and Contamination Control Managers, Quality Assurance/Quality Control personnel, Production and Manufacturing supervisors, Process Engineers, Regulatory Affairs professionals, and anyone working in aseptic or non-sterile GMP environments.
Abstract:
This unique, participant-driven session flips the traditional lecture format to place your most critical questions at the center. "Ask the Experts" is a live, interactive Q&A forum dedicated to the complex world of contamination control and sterility assurance across both aseptic and non-aseptic operations. Guided by seasoned experts, this open-floor discussion allows you to surface real-world dilemmas—from interpreting environmental monitoring trends and designing robust aseptic process simulations, to managing human factors, qualifying sterilization methods, and implementing holistic contamination control strategies. Whether you're grappling with a persistent issue, planning a new strategy, or simply seeking clarity on regulatory expectations, this forum provides a direct line to expert insight. Move beyond theory and engage in a collaborative dialogue designed to provide actionable guidance, enhance your problem-solving toolkit, and strengthen your site's approach to ensuring product safety and regulatory compliance.
Learning Objectives:
Upon completion, participants will be able to:
- Receive direct, expert clarification on complex or ambiguous topics within contamination control, sterility assurance, and related regulations (EMA, FDA, PIC/S, WHO).
- Discuss practical solutions to site-specific challenges regarding environmental monitoring, aseptic simulation, cleanroom operations, and personnel behaviors.
- Explore the application of risk-based principles and Quality by Design (QbD) in strengthening contamination control strategies.
- Benchmark their current practices and investigative approaches against expert insights and industry standards.
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