Aseptic Behavior Online Event

Event Details
Strategic Product Manager
Skan AG
EMEA Training Manager & Critical Environments Specialist
DuPont de Nemours
Principal Consultant
STERIS Corporation
Principal Process Validation Consultant
ValSource Inc.
Associate Director – Manufacturing (Aseptic Fill-Finish)
Terumo

Aseptic behavior remains a critical element of contamination control in modern healthcare and pharmaceutical manufacturing. With increasing process complexity and regulatory expectations—particularly under EU GMP Annex 1—focus is shifting toward human factors, system design, standardization, and data-driven monitoring. This webinar addresses current directions in aseptic performance, emphasizing process reliability, risk reduction, and practical alignment with Annex 1 principles.

Our Focus:

  • Significant influence of human factors on aseptic performance.
  • Variability in definitions and practice reducing reliability of aseptic technique.
  • Impact of system design, standardization, and workflow efficiency on aseptic outcomes, aligned with EU GMP Annex 1 expectations.
  • Role of digital monitoring, tracking, and feedback systems in supporting aseptic practice.
  • Shift toward process reliability and error reduction rather than compliance alone.

    Who Should Attend:

    This webinar is intended for professionals involved in aseptic operations, contamination control, and quality oversight. It is relevant for personnel working in pharmaceutical manufacturing, sterile product processing, quality assurance, quality control, engineering, and regulatory compliance. The content is also applicable to leaders responsible for system design, process reliability, and Annex 1 implementation, including Lean Managers, Operations Managers, Cleanroom Managers, Regulatory Affairs Managers, Production Managers, Quality Systems Managers, and Sustainability Managers.

  • Isolators don’t guarantee sterility—behaviour does
  • Unsupervised decision-making drives contamination risk
  • Aseptic discipline is proven in the grey zones
  • Regulatory failures reflect mindset, not just systems

  • Role of isolators within Annex 1, including expectations for contamination control strategies in aseptic processing
  • Key operational aspects such as glove management and cleaning to minimize contamination risks
  • Principles and validation of decontamination processes to ensure consistent and compliant isolator performance

  • Practical overview of EU GMP Annex 1 (2022) gowning expectations
  • Key contamination risks from operators and how to control them
  • Compliant garment materials, design, and gowning procedures
  • Impact of garment packaging on contamination control
  • Best-practice aseptic gowning and operator behaviour
  • Monitoring and trending contamination on cleanroom exit

  • Aseptic behavior and CCS principles for ATMP cleanrooms
  • Materials transfer of critical items into barrier systems, cleanrooms, air locks, RABS, and isolators
  • Decontamination of process parts that cannot be cleaned or sterilized out of place
  • Control of hard-to-prevent contaminants (viruses, spores, vegetative bacteria)
  • ATMP cleanroom case studies and bioburden control practices
  • Bioburden control for incubators and materials transfer processes
  • Published data and a holistic approach to controlling bioburden in cleanrooms and BSCs

  • Provide practical understanding of US FDA GMP requirements for aseptic processing and cleanroom operations
  • Explain why aseptic and GMP controls are required, with emphasis on product quality and patient safety
  • Impact of aseptic practices on product failures
  • Prepare personnel to manufacture sterile products in a controlled cleanroom environment
  • Reinforce proper cleanroom behavior and personnel practices in classified areas
  • Strengthen correct aseptic technique during routine and critical operations
  • Cover essential principles of microbiology, contamination control, and environmental monitoring
  • Apply learning through interactive discussion and aseptic process simulations

  • 199
    Full Access
  • Full online access
  • Post-event documentation
  • Certificate of attendance
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