Risk-Based Environmental Monitoring (EM) Program

Environmental Monitoring (EM) programs for pharmaceutical manufacturing are consistently moving toward a risk-based approach, using proactive data analysis to control environmental factors in a manufacturing environment. Identifying and mitigating risks up front with sampling data is proving to be much more effective than more reactive methods. However, questions remain about how to shift from a standard EM approach to one that predicts risk early and sets a framework for avoiding it. We will teach you how during this session.

Areas Covered in the Session :

Applying a Risk Management approach to developing an Effective Environmental Monitoring program

  • First lesson learned – describe the different approaches to establishing initial EM sites (Performance Qualification) to ensure sufficient baseline data exist to support cleaning program effectiveness
    • The RPN approach is great
      • Incorporate Risk Mitigation steps to show how the Risks are mitigated
      • Sort the scores to identify what locations are most important
    • Geometrical coverage
      • Cover all areas of the room using equation to determine sampling sites based on room square footage

Implementing a Risk Based E/M Program (making it work in the Real World)

  • Telling the story of how you decided on your E/M monitoring locations becomes part of the Process Development part of Process Validation per the 2011 PV Guidance
  • Trend reports are necessary to determine the effectiveness of the system
  • Revise your E/M locations based on your E/M data. – this will give you credibility with the Agency

Case Study – Dealing with Environmental Control Issues in Cleanrooms

  • You will be dealing with panicky Management
  • Handling the Deviation / Investigation
  • Using Risk Assessment approaches to identify Corrective Actions

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Microbiologists
  • Everyone concerned with environmental monitoring for contamination control and sterility

FDB2808

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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