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How to Design an Environmental Burden Monitoring Program

February 5 @ 8:00 am - 5:00 pm

How to Design an Environmental Burden Monitoring Program

Overview

The environment bioburden monitoring program is a qualified way of tracking, controlling and managing of microbial activities with predefined parameters and specifications in a facility. It includes air, surfaces, personnel and water quality checks and trending the data on regular periodic timeline in the facility to detect any deviation from specified parameters. This program is necessary for sterile or clean room operations in a regulated industry.

Course Outline:

  • Environmental Bioburden Monitoring and its importance.
  • Types of environmental bioburden monitoring used in controlled facilities.
  • Cleanroom grading as per ISO and EU-GMP.
  • Risk assessment and establishment of action/alert limits.
  • Compendial methods for Environmental Monitoring and water testing.
  • Investigation and actions implementation.

Who Should Attend

The recipient of this course will learn how to create Environmental bioburden monitoring program in their facility, evaluate and investigate any out of specifications (OOS) and out of trending (OOT) data. Learners will also gain the knowledge to maintain a controlled environment in sterile or clean room facility. This webinar is useful for personnel working in Pharmaceutical, Food , Cosmetics, Natural Health Products (NHP) or Dietary industry as but not limited to in the following department.

  • Quality Control
  • Quality Assurance
  • Sterility Assurance
  • Environmental monitoring

Details

Date:
February 5
Time:
8:00 am - 5:00 pm