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QP Industry Update
Intensive 2 Day Course
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Although we
recommend that delegates
attend both days to obtain a complete update, each day has been
designed to ‘stand alone’ giving delegates the flexibility of
contributing either one or two days to their CPD programme.
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DATE |
LOCATION |
COST |
RESERVE
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Attend Both Days:
29th -
30th September 2009 |
Honeyman
Group Ltd, Barnard Castle, U.K. |
£700.00 + VAT |
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Attend Day 1 Only: 29th September 2009 |
Honeyman
Group Ltd, Barnard Castle, U.K. |
£350.00 + VAT |
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Attend Day 2 Only: 30th September 2009 |
Honeyman
Group Ltd, Barnard Castle, U.K. |
£350.00 + VAT |
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Course Description:
The QP has a personal responsibility to ensure that they are
adequately trained and that their industry knowledge is current. The MHRA is
becoming particularly keen for QP’s to be able to demonstrate that they are
undertaking frequent and relevant CPD training programmes and many indemnity
insurance companies now insist that policy holders maintain up-to-date training
portfolios. For many individuals it is becoming increasingly difficult to stay
abreast of the numerous changes occurring within the industry.
This intensive two day course will focus on providing delegates with the vital
updates and changes that are happening within today’s pharmaceutical, biotech
and medical device industry.
Presented by people who are active in current industry and regulatory projects,
and designed for QP’s, Consultants, Senior Quality Managers/Directors and
Contractors the course will provide a complete overview of the recent industry
developments affecting the QP’s role and can count towards your CPD. Intensive
learning and group discussion will form the basis of the course delivery.
During the course, delegates will also have the opportunity to meet the Honeyman
Group’s unique team of Microbiologists, Chemists, Engineers and Validation
Professionals and to ask any site specific questions they may have.
A certificate of attendance will be issued to each delegate upon completion of
each day.
'Very
comprehensive, well timed.'
Quality Manager, Thornton & Ross Ltd, Huddersfield, UK
Proposed Course Content:
Please note that due to the nature
of this course, the actual content may vary from that which is
published here.
Each day will start promptly at 08.30hrs and finish at
approximately 18.00hrs.
Day 1
Examining Quality Management Systems
and Reviewing Recent Legislative and EU GMP Updates Encompassing
• Quality Risk Management
• Dedicated Facilities
• Document Management Systems
• Raw Material
• Sterile Products
• Biologicals
• Radio-Pharmaceuticals
• Medicinal Gases
• Herbal Medicines
• Computerised Systems
• Active Pharmaceutical Ingredients (API’s)
• Investigational Medicinal Products (IMP’s)
• Human Blood and Plasma Products
• QP Discretion
Focussing on the Requirements of a Pharmaceutical Quality System
According to ICHQ10, Topics for Discussion Will Include:
• Management Responsibility
• Continuous Improvement
• Process Performance and Product Quality
Day 2
Analysing Additional Changes and
their Resulting Implications, Incorporating:
• Regulatory Variations and Changes
• Clean Room Requirements
• Medical Device Legislation Updates
• Contract Manufacture and Supply
• Contract and Employee QP Expectations
• ICH Updates and Interpretations
• Anti-Counterfeit
• Distinctions and Updates on Expectations: GMP, GCP and GLP
Who
Should
Attend?
The course is designed specifically for:
Other Courses You May Be
Interested In...:
Course Leaders:
Mike
Breese, QP
Mike is an Interim Manager with over 30 years
experience in the pharmaceutical and biotech Industries. He has worked in all
areas of Pharmaceutical Quality and Production from R&D to finished product and
at sites and facilities throughout the world and is a registered QP. A member of
the IOB and a qualified IATCA/IRCA Auditor, Mike has spoken on a variety of
courses including those held by PharMIG, PQC and IIR.
Mark Thompson C.Eng. MIEE BSc
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 Language:
The course will be delivered in English.
The Venue:
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 £700.00/£350.00 sterling + VAT where applicable
dependant upon number of days attended . 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. Written cancellations (received and confirmed by
Honeyman Group Ltd) will be accepted up to 31 working days before the start 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, (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.
