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2018 - The Regulatory Expectations for Environmental Monitoring Programs
Date2018-08-29
Deadline2018-08-28
VenueOnline event, USA - United States 
KeywordsEnvironmental monitoring; Terminal sterilization; Aseptic processing; program FDA
Topics/Call fo Papers
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.
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.
Other CFPs
Last modified: 2018-06-15 14:31:14