Director Single Use Technologies
1:00 PM Afternoon Workshop: Validating and Verifying Your Transition to 100% Single Use Technologies
Transitioning to a 100% Single Use and Disposable Technologies site takes incredible amounts of time and preparation. No two transfer processes look the same – whether it is managing the transition from a mixed facility, building a new line model or replicating a global site – every transition requires effective identification of process constraints and consideration of critical success factors. This workshop will focus on streamlining your transition and adoption process, ensuring you plan ahead for the pitfalls and optimise your process.
Attend This Workshop to:
- Discuss the different solution integration needs of each transition approach: new line model, mixed facility or geo-site replication
- Identify the rationale and technology shaping the adoption process: what is the industry currently capable of?
- Analyse the most proactive ways to qualify your raw materials – what is the effect?
- Examine the current validation standards for your processes; how are you tackling your Extractable and Leachable compliance and closed systems processing?
- Map our a compliant single use and disposable technology process from R&D to regulatory compliance
- Discuss the importance of change control processes in adhering to system quality and efficiency
- Identify all stakeholders impacted in new technology implementation and build a strategy for stakeholder
recruitment to avoid delays in manufacturing processes
- Avoid costly process interruptions by developing a flexible change management strategy to incorporate