BETCO Consulting

Description: Controlling Microbiology throughout the manufacturing process is a key success factor for production. Microbiology is unseen and data is history, effective control requires all disciplines to be involved in the control measures and any out of specification investigations. Therefore, all key personnel should have a thorough understanding of Microbiology. This course is designed to give key personnel a comprehensive introduction to Microbiology so that they can engage in the required control measures, investigations and corrective actions.

This course is aimed at opening your eyes to the world of microbiology and its wide-ranging involvement in many aspects of pharmaceutical control.  Microbiological control is not only a problem for the microbiologists, it's everybody's problem. Significant cost arises from the need to control micro-organisms in and around the product.

Learning Outcomes: 

At the end of the program, all participants will be able to:

• Evaluate and improve current systems in your company associated with microbiology such as: contamination control, aseptic processing, gowning and environmental monitoring 
• Assess aseptic processing simulation studies from a microbiological aspect 
• Develop and/or enhance current microbiology training programs in your company 
• Discuss risk management in terms of action limits, sterility testing, positive media fills and sanitization related issues 
• Review the how’s and why’s of basic pharmaceutical microbiology as it pertains to:  • Quality Control    • Quality Assurance     • Manufacturing     • Validation 
• Reduce microbiological hazards and contamination within your facility
• Review microbiological data and understand the methods of analysis

Target Audience: This course is ideal for all new to the pharmaceutical industry and working in microbiology in-process and finished product control. This course also recommended to personal working in QA, R&D & technicians who are working in cleanrooms like raw materials dispensing unit, solution preparation unit and filling units. 

Methodology
PowerPoint Presentation & Case studies Exercises