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Regulatory Expectations for Environmental Monitoring Programs
This Webinar is over
Date | Sep 7, 2018 |
Time | 03:00 PM EDT |
Cost | $14385.00 |
Online
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The establishment of EM programs is critical to the success of aseptic, terminal sterilization and non-sterile manufacturing facilities as it is a tool for evaluating the adequacy of cleaning programs, personnel gowning and contamination control practices.
This course will focus on three major points:
Areas Covered in the Session :
Who Will Benefit:
This course will focus on three major points:
- The regulatory requirements for environmental monitoring
- The main issues with EM programs such as monitoring locations and the justifications for them, the types of sampling, and the establishment of operational limits
- The handling of excursions and some of the common deficiencies cited by regulatory auditors
Areas Covered in the Session :
- Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
- Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
- Review the issue of contamination control as an important aspect of EM programs.
- Discuss the issue of action and alert limits, trending of data and the handling of excursions.
- What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
- Attendee question and answer period.
Who Will Benefit:
- QA/QC Teams
- Manufacturing Teams
- Engineering Teams
- Validation Teams
- Regulatory affairs Teams
- Management Teams
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