Faculty: Kelly Thomas

Scheduled Date : May 16 2022

Scheduled Time : 1pm -  2:30pm ET

Register Now


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
Read more