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Good Engineering Practice
Intensive 2-Day Course
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DATE |
LOCATION |
COST |
RESERVE
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24th - 25th November 2010 |
Honeyman
Group Ltd, Barnard Castle, U.K. |
£1,175.00 (€1,645.00)
+ VAT
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18th - 19th May 2011 |
Honeyman
Group Ltd, Barnard Castle, U.K. |
£1,175.00 (€1,645.00)
+ VAT |
|
Course Description:
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 course will be suitable for both introductory training and as
a refresher course for engineers already working in the pharmaceutical and
related healthcare environments.
'Excellent course
will
highly recommend to others.'
Supervisor, GE Healthcare Ireland Ltd, Cork, Ireland
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
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
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
Other Courses You May Be Interested In...:
Course Leader:
Mark Thompson BSc (Hons), C. Eng. M.I.E.E.
Managing Director,
Honeyman Group Ltd
Mark's prolific background in the
pharmaceutical and medical device industry spans more than twenty years.
Various engineering management roles with the world’s largest household names
including Eli Lilly, Rhone Poulenc Rorer and Smith & Nephew Medical have seen
Mark leading engineering teams through an array of engineering projects driven
by capacity relief, new product introduction, profit improvement and regulatory
compliance. A Chartered Engineer and Member of the Institute of Electrical
Engineers, Mark primarily specialises in control and instrumentation projects
within sterile manufacturing operations.
Course tutors may vary dependent upon date and location.
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.
Course Fees and Reservations:
The fee for the course is £1,175.00 (€1,645.00)
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.
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