2019 - The Regulatory Expectations for Environmental Monitoring Programs

Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
Discuss the 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 to them.
What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
Attendee question and answer period.