New for 2008 - Sterilisation, Water & Steam GMP & Regulatory Updates Seminar
Based on last year's sell out Sterilisation: Standards Update Seminar

[Download Course Brochure (147Kb)]

Seminar Programme
This is an intensive day focusing on developing regulatory expectations and opportunities.  The final validation lecture will look at ways of delivering compliance in the most cost-effective manner.

The seminar will cover the following:-

• PW and WFI purification and quality requirements

• Pharmacopoeial and GMP updates

• PW and WFI storage and distribution, GMP developments and new technologies

• Steam generation distribution and steam quality expectations

• Steam sterilisation, technological developments and standard updates

• Biological Indicators, pharmacopoeial compliance, independent testing requirements

• Validation of critical utilities and sterilisation processes

• Application of ICHQ9 and the risk based approach

Seminar Description:
The seminar will cover a review of new standards, guidelines and pharmacopoeial changes for European and US compliance, including steam sterilisation, water purification, distribution and use, steam generation and quality and will do so in terms of the documented requirements but also in terms of interpretation , current GMP inspector views and feedback from recent inspections.  As with all our training, the seminar is compiled by professionals who have extensive experience in the Pharmaceutical and Medical Devices Industry and is designed to present an independent view of the current standards and GMP developments and expectations.  This new course is based on the highly successful Honeyman 1 day Sterilisation:Standard Updates Seminar which was introduced in 2007, held at 6 venues and attended by hundreds oh pharmaceutical professionals.  Delegate feedback from these seminars included:

'A very good day and a lot of excellent information sharing'
Caroline Cronin, Pharmaceutical Engineer, GE Healthcare UK Ltd, Amersham

'Very impressed with the knowledge of speakers'
Pauline Johnstone, Validation Manager, SNBTS, Edinburgh

'Workshop session was good for sharing information and approaches'
Rob Loach, Validation Engineer, Wockhardt UK Ltd, Wrexham

'Very relevant to industry - extremely useful'
Ann Harris, Principal QA Officer, Intervet UK Ltd, Milton Keynes

Who should Attend?
The seminar will be relevant for:

• Validation and engineering professionals involved in the design, maintenance and upgrade of water, steam or sterilisation systems

• QA/QC personnel involved in the review and acceptance of related process data or new systems

• Technical and regulatory compliance personnel

• System owners and users

Upon Completing the Seminar, Delegates Will:

• Understand the current expectations for the Design, Validation and Maintenance of such processes

• Be aware of the impact that non compliance will have on your current policies, programmes and strategies

Seminar Leaders:
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.

Gavin Ross BEng: AMIMechE
Operations Director, Honeyman Group Ltd

Prior to joining Honeyman Group, Gavin worked in the Pharmaceutical and Medical Device Industry for 10 years at Convatec and Smith & Nephew Medical.   He has had a variety of engineering roles during this time including Plant Process Engineer, Project Engineer, Site Sterilisation Engineer, Validation Specialist and most recently as Validation and Change Control Manager.    Gavin brings with him a broad range of validation experience including 21CFR part 11, Conversion Processes, Water Systems, Air Handling (HVAC), Cleaning and Aseptic Manufacture.  He also has extensive experience of risk assessment techniques including hazard analysis (HACCP/HAZOP) and Failure Mode Effects and Criticality Analysis (FMECA).

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.

The course language will be English.

The Venues:
Radisson SAS Royal Hotel Dublin, Dublin, Ireland
Tel: +00353 (0) 1 898 2900,     Fax: +00353 (0) 1 898 2909,     Web: http://dublin.radissonsas.com

The Radisson SAS is a newly built hotel at the crossroads of Golden Lane and Chancery Lane and situated in the heart of the city centre.  Located within walking distance from Dublin's top land marks, the hotel has an underground car park and the nearest DART station is Tara Street which is a 15 minute walk from the hotel.

Hotel Mitland, Utrecht, Netherlands
Tel: +0031 (0) 30 271 5824,     Fax: +0031 (0) 30 8271 9003,     Web: www.mitland.nl

Situated on the outskirts of Utrecht approximately a 5 minute drive from the city centre, Hotel Mitland has 135 luxuriously furnished rooms and is situated in a splendid park offering wonderful views of the old 'De Bilt Fortress'.

Seminar Fees & Reservations
The fee for the seminar is detailed above. This covers all tuition fees, comprehensive course notes, refreshments and lunch. A seminar certificate of attendance is issued to each delegate who attends the full seminar.   If required, delegates should arrange their own dinner, bed and breakfast as this is not included in the seminar fee.

Discounts:
Book early and receive a 10% discount if payment is received 6 weeks in advance.   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 working days before the date of the seminar, after which a cancellation fee will be payable.   Unfortunately, no refund can be made for cancellations within 10 working days of the seminar start date and the full seminar fee will be due for delegates who fail to attend.    Substitutions may be made at any time up to the start of the seminar, 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.

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