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2018 - The Regulatory Expectations for Environmental Monitoring Programs

Date2018-08-29

Deadline2018-08-28

VenueOnline event, USA - United States USA - United States

KeywordsEnvironmental monitoring; Terminal sterilization; Aseptic processing; program FDA

Websitehttps://www.complianceonline.com/regulat...

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.

Last modified: 2018-06-15 14:31:14