Pharmaceutical Water Systems: Principles in Practice
March 2008 & October 2008
Intensive 3-day course

[Download Course Brochure (303Kb)]

Introduction
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 2007' 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 Tutors
Andy N Marshall CChem, CSci, MRSC, BSc
Technical and Quality Director, Honeyman Group Ltd
Trained as an analytical chemist, Andy joined Glaxo's Barnard Castle factory in 1990 and was involved with stability testing and formulation development before moving to Sanofi.  At Sanofi, he was involved with cleaning validation before becoming the Equipment Validation Manager.  Andy then moved to primary pharmaceutical manufacture with Chirex as the Validation Co-ordinator, and latterly as the Operational Quality Manager at the Dudley, Newcastle and Annan, Scotland sites for Rhodia Pharma Solutions (RPS) and Shasun Pharma Solutions (SPS).  Andy also spent a period of time in New Jersey, U.S.A. developing the quality systems for the newly acquired pilot plant for RPS.  Andy brings a broad range of validation (in both primary and secondary pharmaceutical manufacture) and quality assurance knowledge, including FDA and MHRA audit readiness activities and involvement.

Mark Thompson C.Eng. MIEE BSc
Managing Director, Honeyman Group Ltd
Mark's engineering background in the Pharmaceutical and Medical Device Industries includes Eli Lilly, Rhone Poulenc Rorer and Smith & Nephew Medical, specialising in Sterilisation Technology, Engineering and Microbiology, and 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, ensuring that the training is always up to date and built upon real life experiences.

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

Course Language
The course will be delivered in English.

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

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..

The Venues
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.

Tara Towers Hotel, Merrion Road, Dublin 4, Ireland
Tel: +353 (0) 1 269 4666,      Fax: +353 (0) 1 269 1027,     Web: www.taratowers.com

The course will be held at the Tara Towers Hotel, a 3 star hotel located just 3km south of Dublin city centre along the curve of Dublin Bay with beautiful views of sea and shore. The hotel is ideally located with easy access to Dublin's City Centre via the "Dart Line" for fast and reliable transport.

Course Fees and Reservations
The fee for the course is £1,325.00 sterling (€1,990.00) 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 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 your 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 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.