Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) — To Include HVAC and Utility Systems: 2- day In-person Seminar

By: Barry A. Friedman, Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
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Course Description:

Environmental monitoring of non-sterile and aseptic processing areas (controlled/classified environments) and utility systems is required to maintain compliance per EU/FDA/Health Canada requirements. When a new or remodeled controlled and/or classified manufacturing area is established, a validation plan is needed to determine manufacturing surfaces, airborne testing (ISO 14644) and the utility monitoring that is required. This testing may extend to the media, personnel, incubators, refrigerators, development of SOPs, etc. The program will involve the DQ, IQ, OQ and PQ of the site and all of its equipment. Since the facility’s environmental and utility plan must be established and in compliance prior to the initiation of manufacturing, an extensive Gantt chart is a prerequisite to assure all activities are completed in a predetermined order and that the earliest possible date for initiation of production may be met.

The necessary regulatory documents also need to be in place and translated into the various SOPs. Significant source documents include ISO 14644, Annex 1 (revised March 2009), FDA’s Aseptic Processing Guidance document, USP (current version), and USP<1111> (for non-sterile products), etc.

The highly interactive two day seminar will explore and define the necessary elements in the development and implementation of an environmental monitoring strategy for a non-sterile and an aseptic processing area to include utility systems (controlled and controlled/classified environment). It will assist in assuring that your organization is maintaining itself within a cGMP compliance framework. Case studies that include Warning Letters will be discussed to illustrate regulatory environmental issues.

Learning Objectives:

Upon completing this course on developing environmental monitoring strategy participants will:

  • Assure their understanding of the fundamentals of an environmental monitoring program
  • Be able to identify the key elements
  • Understand how the regulations impact their cGMP non-sterile or aseptic processing areas and their “Controlled” and “Classified” environment
  • Understanding the various inspection approaches to monitoring a “Controlled” and “Classified” environment
  • Learn how to determine the regulatory requirements required for an environmental monitoring program
  • Be able to develop and initiate the use of a purified water, WFI and steam system
  • Recognize the issues of their water system before the system is commissioned
  • Learn how to use Failure Mode Effects Analyses to determine the critical sampling locations, appropriate sampling methodologies and frequencies for both environmental and utility systems
  • Be able to develop DQ/IQ/OQ/PQ requirements
  • Learn how to determine appropriate Alert and Action Levels for different ISO and water classifications
  • Understand the movement from a “paper” method of data trending

Who will Benefit:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists

Course Outline

Day One (8:30 AM – 4:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  • Overview of the fundamentals of an environmental monitoring program
  • Determination of the regulatory requirements for an environmental monitoring program
  • Review of the Key elements of environmental monitoring program
  • Define the differences between a “Controlled” and “Classified” environment
  • Development of an understanding of various inspection approaches
  • Reviewing of the microbiological issues between a non-sterile and aseptic environment
Day Two (8:30 AM – 4:00 PM)
  • Use of Failure Mode Effects Analyses to determine critical sampling locations, appropriate sampling methodologies and frequencies
  • Developing DQ/IQ/OQ/PQ requirements
  • Determination of appropriate alert and action levels for different ISO and water classifications
  • Moving away from a “paper” method of data trending
  • Case Studies and recent Warning Letters

Meet Your Instructor

Barry_A_Friedman_90_112
Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

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