Level
Intermediate
Format
On-site (Charlottetown), practical, including essential theory
Dates
On Demand
Duration
4 days
Cost
$3,553
Overview
Reliable aseptic fill-finish operations demand more than procedural knowledge—they require disciplined execution, contamination control mindset, and regulatory fluency. CASTL offers a phased training program that prepares participants for real-world fill-finish environments through structured theory, hands-on training, and professional development microcredentials.
Delivered at CASTL’s GMP-simulated Charlottetown training facility, the program combines four days of instructor-led experiential training focused on foundational concepts and hands-on application using barrier technologies (RABS), supported by applied regulatory interpretation and scenario-based troubleshooting. Participants progress from core aseptic principles to operational readiness aligned with global regulatory expectations.
Why It’s Essential
Fill-finish operations sit at the highest risk point of sterile drug manufacturing. This program equips your workforce to:
- Execute aseptic operations with confidence: Apply GMP and Annex 1 principles directly to filling and closing activities.
- Control contamination proactively: Strengthen cleanroom behaviors, gowning discipline, and risk-based contamination control strategies.
- Operate barrier systems effectively: Understand RABS design, glove management, material transfers, and intervention control.
- Interpret quality data correctly: Analyze environmental monitoring trends and apply them to operational decision-making.
- Support inspection readiness: Align practices, documentation, and behaviors with EU, FDA, and WHO regulatory expectations.
- Build professional effectiveness: Earn microcredentials in communication, collaboration, and leadership to strengthen shop-floor execution.
This program delivers high-impact, fill-finish-specific training while maximizing workforce development funding.
Learning Objectives
By the end of the program, participants will be able to:
- Apply GMP and Annex 1 principles to aseptic fill-finish environments.
- Perform Grade B gowning and qualification with disciplined Grade A access behavior.
- Execute and control aseptic techniques, including interventions in critical zones.
- Understand barrier system operations (RABS) and their alignment with isolator expectations.
- Interpret environmental monitoring data and understand its role in contamination control.
- Understand sterile filtration setup, PUPSIT, and filter integrity testing requirements.
- Design, execute, and interpret aseptic process simulations (media fills).
- Conduct manual vial inspection for particulate and cosmetic defects.
- Integrate risk-based thinking and quality decision-making into daily operations.
Who Should Attend
This program is ideal for professionals supporting or operating within aseptic fill-finish environments, including:
- Fill-finish operators and technicians
- Manufacturing supervisors and team leads
- QA, QC, and contamination control personnel
- Process engineers and MSAT professionals
- Teams preparing for regulatory inspections or onboarding new aseptic operations
Structure and Format
- Hands-On Technical Training (4 Days): Instructor-led experiential training covering contamination control, aseptic technique, barrier systems, validation concepts, EM interpretation, sterile filtration, media fills, and inspection readiness.
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