Pda-asiapacific.glueup.com

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 …

Actived: 5 days ago

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

Fill Finish Technology and Patient-Friendly Devices

WEBMedical Systems Global Senior Director Business Development. Fill Finish Technology and Patient-Friendly Devices Virtual Conference Oct 12 - Oct 14, 2020. 2. Despite regulative …

Category: Medical Go Health

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 …

Category: Health Go Health

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 …

Category: Health Go Health

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 …

Category: Health Go Health

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-. …

Category: Health Go Health

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 …

Category: Health Go Health

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 …

Category: Health Go Health

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 …

Category: Health Go Health

2022 PDA Aseptic Processing of Biopharmaceuticals Conference

WEBThe 2022 PDA Aseptic Processing of Biopharmaceuticals Conference will address topics related to the manufacturing of sterile drug products and patient-friendly applications. …

Category: Health Go Health

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 …

Category: Health Go Health

Cleanroom Design: Classification, Qualification, Air Visualization

WEB2023 Annex 1 Workshop Series (Singapore) Cleanroom Design: Classification, Qualification, Air Visualization Andrew Hopkins Director of Compliance

Category: Health Go Health

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 …

Category: Health Go Health