Course Tutors
Mark Thompson B.Sc. (Hons), C. Eng. M.I.E.E. Managing Director, Honeyman Group Ltd
Mark's engineering background in the pharmaceutical and medical device industries includes Eli Lilly, Rhone Poulenc Rorer and Smith and Nephew Medical. Specialising in sterilisation technology, engineering and microbiology, also having extensive regulatory compliance experience. Mark has trained thousands of people around the world and bases all of the training lectures on the practical experience of the Honeyman Group in these fields, so ensuring that the training is always up-to-date and built upon real-life experiences.

Course Description
The validation of sterilisation processes is becoming an increasingly expensive and time-consuming exercise. Developing the correct strategy for the validation and planning the approach up front will significantly reduce problems and expense in the execution stage. Building upon the foundations delivered by our "Sterilisation - Principles in Practice" course, this two and a half day training course delivers a comprehensive review of the performance qualification (PQ) of sterilisation processes, including both thermal and biological validation.

The course utilises many practical experiences and case studies of validation exercises on a number of different sites, dealing with different regulatory bodies. Delegates have found this practical "real world" approach invaluable on previous courses that have been ran successfully throughout Europe.

Course Programme
A summary of the course content is as follows:

• Validation strategies and protocol preparation

• Planning the validation workload for the most efficient delivery

• Data logging and thermal measurement calibration and validation requirements - Validating the Validator

• Biological Indicator (BI) application examples

• BI population and D-value verification requirements

• BIs for porous load, fluid loads and stopper cycles

• Understanding the product effect on the D-value of biological indicators

• Direct Inoculation case study and validation

• Validation of stopper sterilisation cycles using stoppers which have been directly inoculated

• Top 10 issues with sterilisation validation and how to avoid them

• Strategies for handling and reporting deviations

Case Studies:

• Validation of stopper sterilisation cycles. Direct inoculation of stoppers vs BIs.

• Fluids Validation. Product effect on D value of micro organism. Use of Bioburden data.

• Using biological validation data to reduce cycle times on fluids cycles. Cycle efficiency.

Who should Attend?
The course is designed specifically for:

• Validation and engineering professionals involved in or responsible for the validation of sterilisation processes

• Microbiologists responsible for the biological data and the selection and use of Biological Indicators

• Quality Assurance Managers involved in the review and acceptance of validation data

Upon Course Completion, Delegates will:

• Be aware of the current expectations for the validation of sterilisation processes

• Be able to plan and execute the most efficient and compliant validation study

• Understand how to handle deviations and out of specification results

The Venues
Rochestown Park Hotel, Cork, Ireland
Tel: +353 (0) 21 489 0800,     Fax: +353 (0) 21 489 2178,      Web: www.rochestownpark.com

The Rochestown Park is a luxurious manor style hotel with mature gardens, incorporating 163 rooms, an award winning health and leisure centre and Irelands first Thalasso Therapy Clinic. The hotel is only five minutes from Cork Airport.

Novotel York, Fishergate, York, YO10 4FD
Tel: +44 (0) 1904 611660,      Fax: +44 (0) 1904 610925,      Web: www.novotel.com

The Novotel York is a modern hotel situated on the banks of the River Foss and within walking distance of all the major attractions in one of England's favourite tourist destinations. London's Kings Cross is approx. 2 hours away, there is a rail link to Manchester Airport and Leeds/Bradford Airport is convenient. York is easily accessed from major national roads. Parking and leisure facilities are available.

Course Fees and Reservations
The fee for the course is £1,145.00 sterling (€ 1, 725.00) + VAT where applicable . This covers all tuition fees, comprehensive course notes, refreshments and lunch. A course certificate of attendance is issued to each delegate who attends the full course. Delegates should book their own dinner, bed and breakfast, as accommodation is not included in the course fee. The hotel will offer a conference discount rate if you mention that you are a delegate.  Reservations not confirmed by payment within reasonable time will be allocated to any persons on a waiting list. Payments should be made by cheque to Honeyman Group Ltd.

Discounts
Book early and receive a 10% discount if payment is received 6 weeks in advance of the course commencement date.
Discounts are also available for multiple bookings, and for government and regulatory agency employees - please contact us for details.

Cancellations
Written cancellations will be accepted up to 31 days before the start date of the course, after which a cancellation fee will be payable. Unfortunately no refund can be made for cancellations within 10 working days of the course start date and the full course fee will be due for delegates who fail to attend. Substitutions may be made at any time up to the start of the course, free of charge.

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. If cancellation occurs delegates will be notified as soon as possible and will receive a full refund of fees paid. Honeyman Group Limited will not be responsible for transportation, accommodation or other costs incurred due to cancellation.

To avoid disappointment an e-mail/telephone/fax reservation is advisable prior to sending your booking form and payment.