UCPD Pharmaceutical Sterilisation: Principles in Practice®
According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise the risks of contamination, with much depending on the skill, training and attitudes of the personnel involved. In particular, managing sterilisation processes is critical to the manufacture of both terminally sterilised and aseptically prepared products.
The Pharmaceutical Sterilisation: Principles in Practice® course provides delegates with a comprehensive understanding of moist heat and dry heat sterilisation processes from theoretical foundation through to the practical aspects of validation and biological indicators. The course highlights the GMP requirements and current industry expectations for the routine operation, monitoring and control of sterilisation processes and gives practical examples of how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and US regulatory requirements.
This Accredited Specialist Training Course is in association with Teesside University.
Who Should Attend This Course?
The course is regularly attended by Engineers, Microbiologists, Technical, QA and QC personnel as well as Production and Operational personnel.
Key learning objectives of the course are:
- To facilitate delegates to make risk based decisions based on science through increased understanding of sterilisation technology
- To improve regulatory compliance and increase awareness of industry best practice.
- To Increase process capacity
- To reduce re-qualification effort and ongoing costs
- Development of Current Sterilisation standards
- Principles of Moist Heat Sterilisation
- Steam Quality Generation Distribution and use
- Dry Heat Sterilisation and Depyrogenation
- Instrumentation and Control of Sterilisation Processes
- Steam In Place
- Quality Systems Associated with Sterilisation Processes
- Auditing Sterilisation Processes and Preparing for a Regulatory Inspection
- Biological Indicators
- Validation Strategies for Sterilisation Processes
- Routine Operation of Sterilisers
- Continual Compliance Assurance
Course Dates / Costs Description
Please see the table above for the dates of next courses and the costs.
Please note: Our online booking system works in £GBP. The € Euro price is a guide price only. The final € Euro amount payable online will be the current exchange rate of the £GBP amount.
If you wish to raise a purchase order or pay via any other means than Credit Card for a booking then these € Euro guide prices will prevail as being the booking cost despite any fluctuation in exchange rates.
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