Environmental Monitoring and Disinfectant
Efficacy Testing
With Hands-On, Practical Workshops
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COST |
RESERVE
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26th & 27th January 2011 |
Honeyman Group Ltd, Barnard Castle, U.K |
£1175.00 (€1645.00) +
VAT
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Seminar Description:
In today’s society hygiene
has become increasingly important, and it is essential that manufacturers
produce safe products through the control of hygiene and ultimately
biocontamination control. Biocontamination control largely used to be dependent
upon anti-microbial agents, however now that the use of these agents have been
reduced, or even forbidden in some countries, manufacturers need alternative
biocontamination control measures.
Environmental monitoring is a method of biocontamination control, which does not
directly interfere with the product or manufacturing process. Environmental
monitoring of controlled environments represents a critical process control step
in the manufacture of pharmaceutical products with a high emphasis placed on
products manufactured within the controlled environment of a clean room.
However,
given the variety of environments, sampling equipment and methods there is no
definitive standard or regulatory document which defines the requirements for
every scenario or environment as this would be impossible to implement.
Environmental monitoring allows
pharmaceutical manufacturers to continually monitor the effectiveness of control
measures and also allows any threats to the product being manufactured to be
identified. A formal system of biocontamination control should be established,
implemented and maintained within cleanrooms and the associated environments. A
poorly designed or badly managed programme may result in misleading data in
relation to the manufacture or assessment of products.
Environmental monitoring represents a high percentage of the microbial analysis
performed in an average production plant and as such, must be designed and
managed with great care. The programme should involve monitoring of air and
personnel as well as surfaces.
It is
important that through your environmental monitoring programme the focus is
placed on product safety rather than on demonstrating that the perfect sterile
environment exists.
The aim of
this two day course is to deliver a thorough understanding of the many different
considerations in the concepts of environmental monitoring within both sterile
and non-sterile manufacturing environments and is recommended for Quality
Assurance, Quality Control, Production and Engineering Staff.
'Excellent/interactive/extremely useful - thank you!'
Quality Director,
Pharmapak (UK) Ltd, Wirral, UK
Seminar Programme:
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Regulatory Requirements and Recommendations - Especially BS EN ISO 14698 (“Cleanrooms
& Associated Control Environments - Biocontamination Control”) and ISO 14644
(“Cleanrooms & Associated Control Environments - Air Cleanliness”).
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Specific Standards Relating to the Clean Room Environment and the
Environmental Controls and Measures which are Required to be In Place,
Classification of Air Cleanliness.
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How to Choose Representative Sites in the Critical Zone as well as the
Surrounding Areas.
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Viable (Microbiological) and Non-Viable Monitoring.
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Methods and Techniques Available i.e. the Use of Contact Plates for the
Monitoring of Surfaces, Settle Plates to Enable Air Quality Monitoring and
Swabs for the Sampling of Irregularly Shaped Articles and ‘Hard to Reach’
Areas.
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Selection of Monitoring Locations and Frequencies Including Clean Rooms,
Changing Rooms, Manufacturing Areas.
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Interpretation of Results.
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Trend Analysis and Review of Data.
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What to do With the Data Generated?
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How ‘Action’ and ‘Alert’ Levels are Defined as Indicated in The Orange Guide
and What Corrective Actions Should be Taken.
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Handling Out of Specification Results: Investigation of Processes, Analyses
and Controls.
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What do the Results Mean to Your Product?
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Documentation: Presentation of Results, Reports, SOPs.
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Training of Staff in Producing SOP’s, Sampling, Settle and Contact Plate
Siting,
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Latest Industry Trends
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Good Manufacturing Practice (GMP) Compliance
Who Should Attend?
The course is ideal for anyone wishing to gain or increase their knowledge of
environmental monitoring within the pharmaceutical
industry. This two day course will focus on the technical aspects of the subject
areas and will include some practical workshops that will be held in our MHRA
approved contract testing laboratories. Attendance will provide a comprehensive overview of
environmental monitoring and has been designed for
anyone involved in environmental monitoring activities, whether this is during the
design stage, execution or throughout overall management, including:
• Quality Assurance
• Quality Control (Chemists and Microbiologists)
• Regulatory Affairs
• Validation
• Production Managers and Operators
• Auditors
Seminar Leaders:
Denise
Irving
Special Projects Microbiologist, Honeyman Group Ltd
Trained as a clinical microbiologist and having ten years experience working in
medical laboratories, Denise joined Glaxo’s Barnard Castle factory in 1985 and
worked initially within the 'Biological Quality Group'. During her time in
Biological Quality, she was involved with Product, Raw Material, Sterility, LAL
and Water Testing, Environmental Control Sterility Assurance and Method
Validation and became Technical Leader. Denise then moved to 'Operational
Quality' gaining full experience of pharmaceutical manufacturing environments.
Denise joined the Honeyman Group in 2007 and is involved in developing new areas
of business for microbiology and supporting special projects.
Dave
Chadwick
Senior Microbiology Consultant, Honeyman Group Ltd
Roles with
some of the World’s leading research based companies including Shell And
GlaxoSmithKline, followed by five years with Honeyman have resulted in Dave
gaining an impressive knowledge of microbiological analysis, interpretation and
troubleshooting. As the Honeyman Group’s Senior Microbiology Consultant, Dave
has taken the lead role in a number of pioneering projects which have resulted
in the development of new methods and techniques aimed at overcoming problems
with existing standards and increasing the accuracy of the microbiological
analysis of raw materials, finished products and medical devices. Since
the introduction of ASTM:2500, Dave has been increasingly involved in a number
of risk based studies commissioned by clients to identify opportunities to
minimise analytical testing and has latterly been instrumental in the
establishment and operational management of the Honeyman Group’s new analytical
laboratories in Dublin, Ireland.
Plus other invited guest speakers.
Seminar Language:
The seminar will be delivered in English.
Other Courses You May Be Interested In...:
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.
Seminar
Fees & Reservations:
The fee for the seminar is £1175.00 (€1645.00) + 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.
