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 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.
Optional: Teesside University Accreditation Assessment is an option is a bolt-on for this course – click here for more info
|Barnard Castle, UK||10th - 12th September 2013 (3 Day Course)||£1295/€1595||Add to cart|
|Optional University Accreditation||Distance Learning & Assessment in addition to attendance of one of the above courses||£795/€995||Add to cart|
Who Should Attend
Who Should Attend?
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
Course Content Includes:
- 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
Dates & CostsDates and Costs
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.
Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.
Terms and Conditions
Terms and Conditions
Cancellations received and confirmed by Honeyman will incur a 50% fee up until 31 working days before the start date of the course. No refund will be made for cancellations within 30 working days of the course start date and the full course fee will be due for delegates who fail to attend, (even if the course fee has yet to be received).
Substitutions may be made at any time up to the start of the course, free of charge.
Delegates completing the optional Teesside University Accreditation will incur a 50% cancellation (received in writing and confirmed by Honeyman) fee up until 31 working days before the start date of the course, after which the full course fee will be due.
Cheques and Bank Transfers are to be cashed prior to booking confirmation.
We reserve the right to charge an administration fee to delegates who wish to have their place transferred to another course.
Reservations not confirmed by payment by the course start date will be allocated to any persons on a waiting list.
We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event.
In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid.
Honeyman is not responsible for transportation, accommodation or other costs incurred.
A full list of all Honeyman Groups terms and conditions of sale is available on request