Speaker: Kenneth Christie
Date: April Tuesday 11th
Time:01:00 PM EDT | 10:00 AM PDT
Duration: 90 Minutes
Product Code: 700695
FDA has put on environmental monitoring as a way of verifying control of the operational environment. The purpose of the Environmental Monitoring program is to document the state of control of the facility, not to determine the quality of the finished product. During the live session, attendees can ask questions or issues relating to their own environmental monitoring program.
A Quick glance of this webinar
- This FDA webinar will focus on three major points: The regulatory requirements for environmental monitoring
- Issues with environmental monitoring programs like monitoring locations and the justifications, the types of sampling, and the establishment of operational limits and
- What are some of the common deficiencies cited by regulatory auditors?
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 also cover issues dealing with contamination control practices such as minimizing bio-burden levels, batch residuals, proper gowning requirements and personnel training. In addition, the webinar will cover recent revisions to ISO 14642-1 and 2 and how they impact environmental monitoring programs and practices.
Areas Covered in this Webinar
- Review the current regulatory requirements and guidance (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?
About the Speaker
Speaker Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharma and biotechnology industries. He served as a member of the ISPE’s Professional Certification Commission as an Examination Development Committee (EDC) member. Mr. Christie is a speaker and trainer for various organizations in the US, Canada, Europe, and Asia.
About Compliance Global
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