Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production | October 14, 2015 10:00 AM - October 14, 2015 1:00 PM |

Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production

Event Summary

October 14, 2015
October 14, 2015 10:00 AM
October 14, 2015 1:00 PM
(GMT -8:00) Pacific Time (US & Canada)
[email protected]
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This course will focus on three major points: The regulatory requirements for environmental monitoring, Main issues with environmental monitoring 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 what are some of the common deficiencies cited by regulatory auditors.

Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. The purpose of the EM program is to document the state of control of the facility, not to determine the quality of the finished product. Environmental monitoring should promptly identify potential routes of contamination. The environmental monitoring program established by companies is an area of major focus during regulatory audits of sterile products as well as a source of many deficiencies.

Objectives of the Presentation

Review the current regulatory requirements and guidelines (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?

Why Should you Attend

The establishment of environmental monitoring 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. The webinar will cover issues dealing with contamination control practices such as minimizing bio-burden levels, batch residuals, proper gowning requirements and personnel training. In addition, an actual case study of an EM excursion will be used to help attendees understand the depth of investigations expected; the decision process used to evaluate its impact on product produced and then will be given the opportunity to learn the agency's opinion on the investigation performed and their ruling. The course will provide attendees the opportunity to ask questions or issues relating to their own environmental monitoring program.

Who can Benefit

QA/QC personnel
Equipment Vendors

Note: Use Coupon code 1371 and get 10% off on registration.


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