A Risk-Based Approach to Environmental Monitoring – A Review of Warning Letters, Risk Analysis and Industry Best Practices for Data Collection, Monitoring and Trending

Environmental monitoring is a critical focus of FDA and other regulatory agencies, with a large number of FDA citation 483s and numerous warning letters having recently been issued. This live and interactive BenAstrum web training course will review various Warning Letters given to the industry over the past several years and discuss those areas of environmental monitoring that trigger regulator concern.

This course will also present methods of integration for your EM (environmental monitoring) into an overall quality system of compliance, with a discussion of the use of Risk Analysis (RA) as a tool to improve your level of compliance and reduce your Risk Compliance Score for EM. Furthermore, we will review facility validation, personnel flows, equipment flows, baseline monitoring and trending in terms of sterile filling in ISO 5, 6, 7, and 8 roam classifications. Finally, the industry best practices for data collection, monitoring, and trending will be covered, in addition to a demonstration of several RA methods.

Discussion Points:

• Environmental monitoring 483s and warning letters
• Use of risk analysis to determine sampling locations in filling
• “Pitfalls” encountered during environmental monitoring
• Trending of data based on automated systems
• Key validation issues

Learning Benefits:

• Learn about global regulatory requirements for EM
• Review various EM guidelines
• Understand the best approach to tracking and trending
• Evaluate the use of automated systems in EM
• Gain knowledge on key validation issues
• Obtain information on the benefits of the use of risk analysis

Who Can Benefit:

• QA personnel
• QC staff
• Sterility Testing personnel
• Validation personnel
• Manufacturing personnel
• Supervisors
• Training personnel

Please click here for the course agenda