The 2022 PDA Pharmaceutical Manufacturing & Quality Conference is an in-person event that will be held on 6-7 September 2022 in Singapore.
Delegates attending the two-day conference will be updated on the evolving regulatory landscape and technological advancements in the areas of CCS, EM, Sterile, Biopharma and ATMPs. Of particular interest will be case studies where participants will gain a broader understanding and insights into the benefits of implementing specific technologies and processes. The conference will also analyse advancements in CCS, RMM and the use of automation in sterile manufacturing. Conference sessions will cover the following topics:
- Regulatory updates on EM, CCS, Annex 1 (Draft) and Annex 2 Biopharma DS Manufacturing
- Automation and Advancements: Paperless Systems in Manufacturing and QC Labs and DI enhancements
- Sterile Processing: Technology developments in Aseptic Processing and AI supported Visual Inspection
- ATMPs: Control strategies in C>
- Contamination Control: Sterile and Non-sterile contamination controls
- RMM and Automation: Implementation strategies and Micro Lab automation
We’re delighted to announce that Senior Consultants Michelle Peake and Jo Sherriff will be presenting a session dedicated towards ATMPs.
Their presentation will focus on Risk Assessment in Facility Design for Microbiological Control in Cell and Gene Therapy manufacturing. They will discuss the importance of ensuring a process risk assessment (PRA) is developed early in the project with all relevant stakeholder’s involvement, whether for green-field or brown-field construction, or even for existing facilities wanting to transition to GMP operations. The PRA should provide the necessary information to implement the project and to accurately specify the design to ensure microbial control via conducting appropriate facility qualification and process validation activities. The presentation will highlight that the complexities of contamination control of cell & gene therapy facilities together with the requirements for sterile/aseptic manufacture should not be underestimated during the facility design. The presentation will draw on Michelle and Jo’s industry experience and highlight areas of risk that have been mitigated early in the design phase to ensure microbial control.
In addition, Michelle will be moderating a session on ATMP’s.
For more information on this event, do visit: https://pda-asiapacific.glueup.com/event/2022-pda-pharmaceutical-manufacturing-quality-conference-50401/
We hope to see you there!
