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2024 PDA Pharmaceutical Manufacturing & Quality Conference

WEBPost-Conference Workshop: 2024 PDA Sponsored Workshop - Environmental Monitoring: Science-based Decision Making. 2024 PDA Pharmaceutical Manufacturing …

Actived: 4 days ago

URL: https://pda-asiapacific.glueup.com/event/2024-pda-pharmaceutical-manufacturing-quality-conference-95231/

Importance of Container Closure Integrity in Autoinjector

WEBPassion for Health. Samsung Bioepis is a biopharmaceutical company. focused on increasing patient access to high-quality medicines through the development of …

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Speakers ⇽ 2024 PDA Pharmaceutical Manufacturing & Quality …

WEBMark Chua Principal Research Engineer II Manufacturing Control Tower at Singapore Institute of Manufacturing Technology, Agency for Science, Technology and Research …

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Industry Perspective on Annex 1

WEBTake a phased approach to from Classification (particulate clean-up performance) into qualification that verifies both particulate and microbial contamination levels do not …

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Agenda ⇽ 2024 PDA Pharmaceutical Manufacturing & Quality …

WEBDesign of Experiments (DoE) is an integral component of the Quality by Design (QbD) framework in CMC. It maps the design space for the Process Parameters …

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Evolution of Aseptic-Containment in Biological and ATMP …

WEBThe Amplex® Red Hydrogen Peroxide Assay Kit (Thermo Fisher Scientific) contains. a sensitive, one-step assay that uses the Amplex® Red reagent (10-acetyl-3,7-. …

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Regulatory, Process and Supply Chain Challenges and …

WEBAdvanced Therapy Medicinal Products (ATMPs) are becoming game-changers by demonstrating sustainable improvement or even cure for various chronic …

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Sponsors and Partners ⇽ 2024 PDA Pharmaceutical Manufacturing …

WEBCYTIVA. At Cytiva, we envision a world in which access to life-changing therapies transforms human health. With a rich heritage dating back hundreds of years, our …

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Sampling in an Aseptic Process Risk Mitigation & Regulatory …

WEBMost members: 1 to 10 CFU/mL. Upstream (conducive for proliferation): Near sterile; Downstream: ≤ 10 CFU/mL. Control levels are set prior to product licensure. “After …

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Overview of Cross-company CMC Discussions Related to …

WEBAluminum salts or Adjuvant Systems. (combination of immunostimulatory molecules) may be a component. Needed for most of the inactivated (whole or subunit) vaccines to …

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Characterization of Airflow Patterns, Identification of Barrier …

WEB8. What Companies Do After a Bad Smoke Study (Air Flow Visualization): Modify cleanroom/barrier system or personnel behavior to address the problem and repeat the …

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Dr Marguerite Evans-Galea AM Director, Cell and Gene Catalyst

WEBInternal use Mission Objectives Actions To create an end-to-end world-class value chain, that can discover, develop, and distribute cell and gene therapies, creating an Australian …

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Agenda ⇽ 2023 PDA Aseptic Processing of Biopharmaceuticals

WEBAs of August 25th of this year (effective date of EU/PICS Annex 1), there is a regulatory requirement to provide continuous viable monitoring not only in the Grade A …

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Steering Committee ⇽ 2023 PDA Asia Pacific Regulatory …

WEBBruce provides inspection readiness and compliance guidance to GSK Vaccines manufacturing network, focusing on AsiaPac. He is responsible for performing pre- Prior …

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