2024 PDA Pharmaceutical Manufacturing & Quality Conference

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Target Attendees:

Auditors, BioMonitoring Specialists, Biotech Managers, Head of Plant, Managing Directors, Microbiologists, Production Manager, Quality Assurance Managers, Quality Control Managers, Research and Design Specialists, Regulators, Regulatory Compliance Managers, Consultants, Technical Account Specialists, Unit Managers

Environmental surveillance assesses the effectiveness of the manufacturing site controls. Environmental monitoring (EM) of cleanrooms and controlled environments serve as an adjunct to the sterility assurance program for microbial quality of drugs. A robust EM program considers technical fundamentals and a risk-based approach. However, there is no prescriptive approach, and the various forms of guidance available often leave room for a degree of flexibility, which sometimes can be ambiguous. A plethora of decisions which must be considered are often taken for granted, such as where and how often to monitor, what samples to take, what culture medias to use, single/dual incubations, how to interpret data, and which identifications to perform.

This workshop will center on Technical Report (TR) 13: Fundamentals on an EM program and will also examine interactive case studies shared by our subject matter experts.

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"Events organised by PDA APAC team have provided the pharmaceutical industry a platform to share the knowledge and network with each other. I'm grateful to be part of this dynamic community and look forward to the continued growth and opportunities that they will bring."  

  - Hue Kwon, Vice-President at Samsung Bioepis, Steering Committee Chair of 2023 PDA Korea Conference and Member, PDA Regulatory and Quality Advisory Board