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

Duration: 90 Minutes
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.
Instructor: Kenneth Christie
Product ID: 501062

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
  • Manufacturing
  • Engineering
  • Validation
  • Regulatory
  • Management
  • Equipment Vendors
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Prior to joining VTS, Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility in Rochester, MI. While there, he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. Additional responsibilities included routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
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