Post Conference Focus Day
9:00 am - 9:30 am Welcome Coffee
9:30 am - 12:00 pm Morning Workshop: Single Use Technologies – Risk Mitigation and The Move to Continuous ProcessingDr Irwin Hirsch - Owner and Principal Consultant, Q-Specialists
With Single Use and Disposable Technology adoption growing more commonplace across the biomanufacturing space, now is the time to ensure that your process development strategy and equipment will support your product development, not stand in the way. This workshop will focus on maximising the opportunities presented by single use and disposable solution adoption, whilst identifying and proactively mitigating against the risks involved through process design strategy formation, quality assurance and the environmental impact factors.
Part 1: Identify the opportunities and mitigate against the risks as a Disposables User with an in-depth analysis into :
- Risk Mitigation strategy’s and lean manufacturing processes to reduce cost
- Disposables Lifecycle management
- Regulatory Framework requirements and challenges
- Extractables and Leachables impact minimisation and process validation
- Particulate presence and mitigation techniques
Part 2: Analyse the applicability of Single Use Technology for Continuous Processing
- Define the realities of continuous processing: Is this just a buzz word? What do we actually mean?
- Identify the key concern in disposable utilisation: Feasibility of SUT for Chromatographic Processes
- Discuss the realities for SUT in continuous processing across upstream and downstream processes
- Map out a plan to future adoption: examine where are we now and discuss where we want to go with continuous processing adoption and what we need to achieve to do this
Dr Irwin HirschOwner and Principal Consultant
12:00 pm - 1:00 pm Networking Lunch
1:00 pm - 4:00 pm Afternoon Workshop: Validating and Verifying Your Transition to 100% Single Use TechnologiesFrancis Verhoeye - Director Single Use Technologies, GSK Vaccines
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
Francis VerhoeyeDirector Single Use Technologies