Join us for a comprehensive webinar on establishing a local facility isolate program based on environmental and process monitoring microflora trending and the critical role of the isolate program in ensuring product quality in the pharmaceutical industry.

This session will delve into the applicable regulations and standards, such as pharmacopeias, ANNEX 1, and industry guidance, shedding light on the significance of local isolates. The presentation will provide guidance on practical implementation of a local facility isolate program and its use to support Quality Control (QC) testing and Contamination Control Strategy (CCS).

Learn how to establish a robust local facility isolate program to support routine QC testing and validation studies that ensure detectability of likely contaminants in environment, utilities and process and confirm effectiveness of disinfectants. Don't miss this opportunity to gain valuable insights and strategies for optimizing your local facility isolate program.

In this webinar you’ll learn:

• Understand the Regulatory Landscape: Explore the landscape of applicable regulations and standards, including pharmacopeias, ANNEX 1 and industry guidance, and gain insights into their practical implications for your company
• Building a Robust Local Facility Isolate Program: Learn the best practices for establishing and maintaining an comprehensive isolate program, covering crucial aspects such as environmental monitoring, product testing, and aseptic process simulation recovery and isolate trending
• Leveraging Local Facility Isolates: Uncover the benefits of incorporating local facility isolates into routine QC assays and required validation studies (e.g., disinfectant efficacy and method validation), including confirming detectability of likely contaminants and improving quality control microbial methods
• Application of an Actual Industry Local Isolate Program: Gain actionable strategies for ensuring compliance with regulatory requirements and elevating the reliability and validity of your QC assays and CCS

• Microbiologists
• QA
• QC
• Validation