The Qualified Person needs to understand the significance of the presence of bacteria, yeasts, moulds, viruses and toxins in pharmaceutical raw materials, intermediates, products and pharmaceutical production environments. In addition, the QP needs a good understanding of the microbiological control of pharmaceutical products, production environments and people.

This course will cover the main types and sources of micro-organisms and the issues associated with them in relation to both sterile and non-sterile pharmaceutical production. Specific sessions will cover water systems, clean room design and operation, the concept of sterilisation and sterility assurance.

This course is one of a series of modules designed specifically to satisfy the requirements of the QP study guide. It is a popular module for trainee QPs who are non microbiologists. It will also be of benefit to other Quality Professionals, Production Technologists and support functions. In addition, this module produces an ideal opportunity for those who need to ensure they carry out Continuing Professional Development.

LEARNING OUTCOMES

At the end of the course you will:

• Understand the sources and types of microorganisms relevant to pharmaceutical production operations
• Understand the microbiological controls required for both sterile and non-sterile products
• Appreciate the microbiology of water, its production and distribution systems
• Appreciate test methods often used and the interpretation of microbiological data

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