Background

Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies. This fact is highlighted in the revised version of Annex 1. Contamination control for sterile, non-sterile, low-bioburden and cell and gene therapy manufactured products will all be included in this course with discussions around the differences in each area.

This two-day training course will be a complete review of all aspects of a contamination control program. A review of the regulation and requirements will be performed along with discussions around practical deployment of the requirements as well as challenges and solutions.

This interactive course will provide a detailed review on how to establish and maintain an effective risk based EM Program. Cleanroom classification, HVAC Qualification (EMPQ) and routine environmental monitoring requirements and best practices will be discussed along with establishment of cleaning/disinfection programs and disinfectant efficacy testing. EM alert/action level setting, EM excursion investigations and microbial identifications will be discussed.

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Learning Objectives

• Apply current regulatory guidance to your environmental monitoring program and contamination control strategies
• Review and discuss the NEW contamination control requirements in the revised Annex 1
• Understand the requirements of cleanroom classification and ongoing monitoring according to ISO 14644-1,2
• Describe and discuss industry best practice and requirements for establishing cleaning and disinfection programs
• Discuss disinfectant efficacy studies
• Describe how to implement environmental monitoring risk assessments
• Understand differences in EM requirements for non-sterile, low-bioburden, cell and gene therapy and sterile product manufacturing
• Discuss how to create and perform EM performance qualifications (EMPQ)
• Compare and contrast new and existing environmental monitoring equipment
• Explain how to conduct EM investigations
• Describe how to establish EM alert and action levels and how to prepare meaningful trend reports
• Describe and review microbial identification instruments and methods
• Understand how to establish the best microbial control strategy for your company