Pharmaceutical Water Systems: Principles in Practice

Intensive 3-day course

DATE	LOCATION	COST	RESERVE
5th - 7th October 2010	Novotel, York, U.K.	£1,575.00 (€2,205.00)
8th - 10th March 2011	Honeyman Group Ltd, Barnard Castle, U.K.	£1,575.00 (€2,205.00)

Course Description:

Water is used throughout the Pharmaceutical industry, as a raw material, a process intermediate, product ingredient, or as a finished product itself. Its wide use in many applications demands that manufacturers look very closely at regulatory requirements, specifications, purification methods, installation and validation. Water systems are always a major area of interest during regulatory inspections and still represent a significant cause of many non-compliance issues.

'Principles in Practice' is the latest in the successful series of pharmaceutical water courses and workshops developed and presented by the Honeyman Group, who are recognised leaders in the field of high purity water systems. The course material is constantly updated to reflect the latest regulatory and cGMP guidelines and expectations and presents a complete overview of best industry practices in the design, installation and routine operation of high purity water systems.

Course Programme:

This course presents an independent view of the design, qualification, validation, operation, management and maintenance of high purity pharmaceutical water systems and provides an interactive mix of lectures and workshops. Subjects covered include:

• Pharmacopoeial water qualities (USP, Pharm.EUR) and their applications (purified water, bulk WFI, WFI etc)

• Basic microbiological aspects of high purity water systems

• Purification methods for high purity water

• Sanitisation of pharmaceutical water systems

• Approaches to water system validation

• Maintenance of water systems

• Quality systems associated with high purity pharmaceutical water installations

• Routine QC of high purity pharmaceutical water installations

• Biofilms - properties and significance

• Auditing water systems and preparing for a regulatory inspection

• Future concepts - HydroGienic®: a new solution for cost effective water distribution systems

• GMP aspects of sanitary equipment e.g. piping and valves

• Instrumentation and controls

Upon Course Completion, Delegates Will:

• Understand the regulatory requirements, standards and expectations for high purity water systems

• Learn about common problems and how to avoid them;

• Understand how to design, build, validate and manage water systems cost effectively;

• Be able to compare different strategies for generation, pre-treatment, storage and distribution of pharmaceutical water and choose the best for your application.

Who Should Attend?

The course will raise practical understanding and awareness for all personnel involved in pharmaceutical water systems, including:

• System owners and users;

• Engineers involved in design, installation, validation and routine maintenance;

• Technical and validation personnel

• Personnel involved with risk assessment, troubleshooting and auditing activities for high purity water systems;

• Microbiologists, Quality Assurance/Quality Control and Regulatory personnel

Other Courses You May Be Interested In...:

• Good Engineering Practice

Course Leader:

Dr John Hutcheson BA, PhD, CChem, MRSC
Principal Consultant, Honeyman Group Ltd
John is an independent consultant, specialising in pharmaceutical water systems, validation and technical authoring. With a PhD in organic synthetic chemistry, John spent 3 years working in down stream processing at Beecham Pharmaceuticals followed by 5 years in product design and sales with Millipore where he specialised in Water Systems, Filtration Systems, Chromatography and Microbiological Monitoring Systems. John was a founding member of Ionpure Technologies Ltd, European Pharmaceutical Technology and Marketing Group Manager for USF and subsequently General Manager of USF Ionpure Permutit). John has also spent some time as an Operational Director with BioKinetics, a world leading engineering and high purity piping company and as the Pharmaceutical and Life Sciences Business Unit Manager with Christ Water Technologies.  A highly regarded and well published author of papers on various aspects of water purification, John not only lectures at Cranfield University, Brighton University, PharMIG/Manchester University and the European College of Validation but is also frequently invited to speak at a number of leading conferences, seminars and training courses.

In addition to the leading course tutors, other experienced speakers from industry will be present throughout the course.

Course Language:

The course will be delivered in English.

The Venues:

Honeyman Group Ltd, Barnard Castle, UK
Tel: +44 (0)1833 690101,     Fax: +44 (0)1833 690102,      Web: www.honeyman.co.uk

For courses held in our purpose built facility in our Barnard Castle Head Office, we recommend the Jersey Farm Hotel for those who require accommodation.  We offer delegates a pick up and drop off service to and from the hotel and our office on the course days.
The Jersey Farm (Tel: +44 (0)1833 638223, Fax: +44 (0)1833 631988, www.jerseyfarm.co.uk) is situated in its own grounds within 10 acres of farm land, just a two minute car journey from the centre of Barnard Castle, an historic market town full of character built around the 12th Century castle from which it takes its name.

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 £1,575.00 sterling (€2,205.00) plus 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 arrange their own dinner, bed and breakfast, as it is not included in the course fee. Remember, when reserving your accommodation to mention that that you will be attending a Honeyman course, this will entitle you to the discounted room rates that we have negotiated for you. For ease and convenience, we recommend that you stay in the hotel which is hosting the course. However, alternative accommodation can be arranged, details of which can be obtained from the local tourist information centre.

Booking Conditions

Book early and receive a 10% discount if payment is received 6 weeks prior to the course start date. Further discounts are also available for multiple bookings and for government and regulatory agency employees - please contact us for details. Cancellations received and confirmed by the Honeyman Group will incur a 20% fee up until 31 working days before the start date of the course, after which a sliding scale of further cancellation fees will be applied. No refund will 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, (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. 

Reservations not confirmed by payment by the course start date will be allocated to any persons on a waiting list. Payment can be made by bank transfer or cheque. Alternatively register via our website and pay by credit/debit card.

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 Group Ltd will not be responsible for transportation, accommodation or other costs incurred due to cancellation. We reserve the right to charge an administration fee to those delegates who fail to attend a course through no fault of Honeyman Group Ltd, but wish to have their place transferred to the next available course.

To reserve your place, please complete a Registration Form and a Payment Details Form and forward to Honeyman Group Ltd by either by post, fax or e-mail. Or register via our website at www.honeyman.co.uk Upon receipt of registration, Honeyman will forward written confirmation and VAT invoice.

Receipt of this form by Honeyman Group Ltd consists a binding registration.

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