Regulatory Expectations for Environmental Monitoring Programs

Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.

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:

• 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

The webinar will also discuss issues dealing with contamination control practices such as minimizing bio-burden levels, batch residuals, proper gowning requirements and personnel training. To promote better understanding of the subject, an actual case study of an EM excursion will be used to help attendees apprehend the depth of investigations expected; the decision process used to evaluate its impact on product produced; and learn the agency’s opinion on the investigation performed and their ruling.

The webinar will demonstrate how EM programs provide meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas.

At the end of the session, attendees will be encouraged to ask questions and discuss issues relating to their own EM program.

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 Should Attend:

• QA/QC Teams
• Manufacturing Teams
• Engineering Teams
• Validation Teams
• Regulatory affairs Teams
• Management Teams