- Secure program implementation (microbial)
- Sampling method: best practices
- Optimsing EM procedures
- Data analysis and interpretation
- Compliance to the most relevant guidelines and significant increase of regulatory requirements in progress
- Latest trends assessment in order to minimize both false negative and cross contamination
Environmental Monitoring School and Advanced Operator Training
Understanding Good Practice in Environmental Monitoring |
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In the pharmaceutical industry (significantly in aseptic or parenteral production) Environmental monitoring (EM) plays an important role to ensure the safety during the manufacturing of health care products. The implementation of a detailed and reliable EM program will reduce the number of corrective actions and related investigation and report time. In the worst case an EM contamination could lead to the loss of an entire production badge.
Only personnel who have been trained, qualified and certified on the different aspects of EM (guidelines for monitoring air, surface and personnel) is able to minimize the risks and to maintain the required production quality in isolators, RABS (Restrictive Access Barrier Systems) and cleanrooms. The EM school will help you and your company to release safer products with the highest quality.
Overview (One-and-a-half-day course)This one-and-a-half-day course provides an in-depth review of the regulatory requirements of environmental monitoring of cleanrooms, its validation and practical implementation. The course is based on the most recent editions of GMP and USP guidelines and provides information about cleanroom classification and monitoring according to the ISO standards. As an essential part of the course, you will participate in an interactive workshop on how to implement an environmental monitoring program. Our experienced instructors also provide valuable suggestions for taking the most adequate environmental sample. The course provides an in-depth review of technical and regulatory information on monitoring the air, surface and personnel in cleanrooms, isolators and RABS used in the pharmaceutical industry.
Interactive Workshop
The interactive workshop is a core part of the course, helping to understand the lecture content with practical applications. All critical handling steps in the particle and microbial monitoring procedure and its consequences for test results are discussed and solutions are explained and demonstrated.
| Which of your environmental monitoring challenges does this course address? |
| What will be covered in the interactive workshop? |
| What will you be able to do after attending this course? |
| What will you receive? |
| Who should attend? |
| Which topics will be discussed? |
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