CPD Hours: 21
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.
The classroom version of this course, includes a microbiology practical session on the third day, run at RSSL's microbiology and sterility laboratory in Wokingham.
At the end of the course you will:
A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.
Jamie currently heads the sterility testing team within the pharmaceutical microbiology department at RSSL, he oversees validation, method development and the routine analysis. Jamie has experience in sterile and non-sterile manufacturing environments and is a microbiology consultant to both the sterile and non-sterile pharmaceutical sectors.