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Good Engineering Practice
May 2008 & November 2008
Intensive 2-day course
[Download
Course Brochure (310Kb)]
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DATE |
LOCATION |
COST |
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14th - 15th May 2008 |
Tara Towers
Hotel, Dublin, Ireland |
£1,025.00 (€1,545.00)
+ VAT |
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10th - 11th September |
Hotel Mitland, Utrecht, Netherlands |
£1,025.00 (€1,545.00)
+ VAT
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25th - 26th November 2008 |
Honeyman
Group Ltd, Barnard Castle, U.K. |
£1,025.00 (€1,545.00)
+ VAT |
Course Background
Engineers from all disciplines play a key role in the development and
manufacture of pharmaceutical products, with involvement in the design,
qualification and subsequent maintenance of the facilities, utilities and
equipment necessary for the various stages of production. The application of
Good Manufacturing Practices to engineering and technical activities is
essential to ensure that a company manufactures products of the
required quality.
The purpose
of this course is to highlight how current GMP's are applied to pharmaceutical engineering
and technical services to ensure facilities, equipment and processes are
maintained to the highest possible standards expected by the Regulatory
Authorities. This seminar will be suitable for both introductory training and as
a refresher course for engineers already working in the pharmaceutical and
related healthcare environments.
Course
Programme
A key objective of the course is to ensure that delegates acquire
the appropriate knowledge of the current engineering practices and technologies
as they are applied within the pharmaceutical and medical device industries.
Subjects that will be covered include:
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The role of engineering and the engineer in the
pharmaceutical industry. Duties, responsibilities and the application of
Quality Assurance principles to engineering services
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Current international GMP regulations and
regulatory requirements (EU, PIC/S, US-FDA) as they apply to engineering
activities
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Good Manufacturing Practices with respect to
following key quality systems within the engineering environment
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Equipment specification and selection (URS)
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FAT's and SAT's
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Risk Assessment and qualification requirements
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Equipment qualification (DQ, IQ, OQ)
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Retrospective qualification of existing
installations
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Technical change control - what constitutes a
change and how it is managed
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Planned preventative maintenance
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Training of personnel
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Contractors - selection and supervision
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Controlled documentation and record keeping
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The manufacturing environment, including
current applicable clean room standard for sterile and non-sterile dosage
forms (EU GMP Annex 1, ISO 14644)
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System design considerations
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Qualification parameters as built, in operation
and routine requalification
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Routine maintenance and calibration procedures
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Risks and problems associated with clean room
installation and operation
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Services and utilities
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Pharmaceutical high purity water systems
(design considerations, qualification and routine maintenance and
calibration)
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Clean steam (design considerations,
qualification and routine maintenance and calibration)
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HVAC
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Sterilisation Processes
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GMP risks and problems associated with utility
installations
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Auditing and self inspection programmes for
technical services
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Instrumentation and controls
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Control system validation
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Data integrity
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Computer system validation implications
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Application of GAMP requirements
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Cleaning and cross contamination and the impact
upon engineering activities
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Review of current regulatory concerns with
engineering and technical activities
Who should
Attend?
This course will be relevant for all personnel who are actively involved
in engineering and technical services within the pharmaceutical and related
health care industries. In particular, the following would benefit from this
course:
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Engineers who are new to the pharmaceutical industry and who may be
involved with the design, installation, validation and routine maintenance
of pharmaceutical equipment and utilities
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Engineers currently working in the industry, as a refresher course
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QA/QC and production personnel wishing to gain
further insight into current Good Engineering Practices
Upon Course Completion, Delegates will:
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Understand the
regulatory framework for GMP and the role of the engineer in meeting quality
objectives for pharmaceuticals (safety, efficiency, quality)
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Understand current
Good Manufacturing Practices as they apply to engineering and maintenance
activities in the pharmaceutical industry
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Have gained an
overview of critical utilities, including water and steam and their impact
on GMP compliance
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Understand the
principles of quality systems as they relate to engineering services
Course Tutors
Mark Thompson BSc (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.
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.
Dr Arthur Bradley PhD,
CChem, MRSC
Principal Consultant, Honeyman Group Ltd
With over thirty years working in
the pharmaceutical industry, Arthur has experience across a range of areas and
companies, including Glaxo, Cyanamid, and Fisons (subsequently RPR and
Aventis). He worked initially in analytical development, then chemical
development, API product support and process development, prior to over twenty
years experience in the pharmaceutical development area. He has wide
experience of the development and scale up of a range of products, including
solid dose, suspensions, and sterile solutions, through pilot manufacture, to
their implementation as routine validated production processes, both in the UK
and overseas, in existing and new facilities. He also had responsibility for
the introduction of new technology for existing products and the inter site
transfer of existing products.
Course tutors will vary dependent upon date and location.
Course Language
The course will be delivered in English.
The
Venues
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.
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'.
Enjoy an extensive lunch or dinner at the beautiful restaurant
situated on the waters of ‘Fort de Bilt’ or relax by participating in one of the
extensive activities offered by the hotel including; bowling, swimming, cycling,
jogging or walking.
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.
Course Fees and Reservations
The fee for the course is £1,025.00 (€1,545.00)
plus VAT where applicable. This covers all tuition fees, comprehensive course
notes, refreshments and lunch.
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 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.
[Download
Booking Form 109Kb]
To avoid disappointment an e-mail/telephone/fax
reservation is advisable prior to sending your booking form and payment.
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