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Compliance & Validation Services
Presents a 3-Day Training Course on:
Pharmaceutical Cold Chain &
Storage Conditions Qualification
14, 15 & 16 October 2014
Radisson Blu Hotel, Amsterdam
General Considerations:
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Types of temperature controlled storage units/facilities used and the potential level of
product/patient risk involved
What do the regulations and international/regulatory guidelines say?
Risk Management throughout the storage and distribution chain
Basing level and depth of testing on risk (Quality Risk Assessments)
Storage:
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Minimising compliance/patient risk through effective design
Fundamental design principles for controlled storage units
Mapping, qualification and monitoring requirements for fridges, freezers, cold stores,
incubators, stability cabinets, large stores/warehouses
Types of temperature mapping and permanent environmental monitoring
equipment/systems available and the validation of these systems
Distribution:
Photo courtesy of Sensitech Inc. (part of United Technologies Corporation)
Click on text to visit their website
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Typical examples of distribution chains and the problems that may arise
Understanding your company’s distribution chain and the inherent challenges involved
Distribution strategies (best practices to reduce risk and cost)
Types and design of storage units and vehicles
Cold box qualification
Using a climatic zone approach to rationalise the qualification work involved
Qualifying temperature controlled vehicles
The use of simulation software to predict vehicle capability through different
environmental challenges and support the qualification studies
Course Summary: Pharmaceutical Cold Chain & Storage Conditions Qualification - 14, 15 and 16 October 2014 – Radisson Blu Hotel, Amsterdam
This course not only covers the fundamental considerations, challenges and solutions for effective cold chain management, it goes that one stage further and gives delegates an in-depth
appreciation of the key design/construction considerations and attributes of storage facilities and distribution systems, together with practical strategies and techniques for validating/qualifying the
systems involved. Included within the scope of this course are areas such as: key regulatory rules and guidance; key guidance and instructions from international organisations; design and
qualification of storage systems from ‘bench’ type through to large storage facilities; cold box qualification for range of climatic conditions (rationalising qualification strategy); vehicle design and
qualification; distribution strategies; monitoring systems (including qualification); risk management and important qualification document considerations.
The course will be presented by industry experts who collectively have worked with storage units, facilities and cold chain distribution for many years. Their considerable hands-on experience
and knowledge base will provide learning on current industry best practice, using practical real-life examples. There will be numerous opportunities to put the learning into practice during
carefully chosen case studies.
Day-time meals and refreshments together with a drinks reception and course dinner, held on the evening of Day 1, are included in the overall package.
Presenters
Mike James, Director, Compliance & Validation Services Limited.: Mike has over 20
years experience in the pharmaceutical industry, working in a variety of compliance and
validation roles. His experience includes preparation and delivery of national/clientbased validation training courses, hands-on validation work, validation project
management and regulatory compliance consultancy. Previously, Mike spent four years
as the Site Validation Manager for GlaxoSmithKline (GSK) at Speke, where he was
responsible for all site validation activities, including the development and maintenance
of the Site Validation Programme. Before moving to the pharmaceutical industry he
spent 15 years as an industry chemist.
John Welbourn, Director, Compliance & Validation Services Limited: A validation
professional with over 20 years experience, John has been responsible for the management
and execution of validation projects for many major pharmaceutical companies. He has
broad experience in the qualification of equipment, utilities and computerised systems, and
thermal mapping to support storage conditions. He has presented at conferences in the UK,
Europe and the US and has authored several articles on various aspects of validation. John
has contributed to The University of Manchester’s, Pharmaceutical Engineering Advanced
Training (PEAT) Course and Dublin Institute of Technology’s (DIT) MSc. course in
Pharmaceutical Process Validation.
Brian Collins, Global Operations Manager, GE Healthcare Life Sciences: Brian is
responsible for supporting the Global Scientific Asset Services (SAS) team by building
robust operational infrastructure, and enforcing adherence to processes to ensure and
improve Global Operational excellence in this business unit. He is also accountable for
the oversight of the implementation of new SAS programs into customer sites. Brian has
held senior management positions covering a variety of quality and validation roles
including responsibility for providing technical support to develop best practice, novel
solutions and harmonized processes in cold chain and validation whilst working for
Wyeth. Brian was also responsible for managing validation activities at Wyeth’s UK
manufacturing site. He has developed extensive cross-functional experience through a
number of quality, pharmaceutical technology and operations management roles
Richard Peck, Senior Program Manager, Sensitech Inc.: Richard has worked in the Life
Sciences industry for over a decade. Working as a Thermal Compliance and Process
Improvement Specialist, his role is to assist customers in maintaining an efficient and robust
Cold Chain Management Program whilst staying compliant to GDP regulations. He started
his career as a mechanical engineer at GlaxoSmithKline and moved to Wyeth where he
managed the Cold Chain Technology team at their EMEA Cold Chain Centre of Excellence.
Prior to Sensitech, Richard was the Global Head of Technical Services and Quality at
Softbox Systems Ltd., a leading global manufacturer of temperature controlled passive
shipping systems. He is an active member of the PDA’s Pharmaceutical Cold Chain Interest
Group where he sits on the European Steering Committee. He also resides on the
International Air Transport Association’s (IATA) Time and Temperature Task Force.
Who Should Attend
Individuals to benefit from attending this course include anyone involved in the management, operation, engineering, quality assurance and validation of fridges, freezers, cold stores, cold boxes,
incubators, warehouses/intermediate storage facilities and temperature controlled vehicles. The course will also benefit people involved in distribution management of pharmaceutical
products/materials. On leaving the course delegates will: be equipped with the latest regulation and guidelines; have a broad and detailed understanding of the design, construction and
qualification of storage and distribution systems; be able to apply and share their new knowledge; improve their individual effectiveness; and look back on an enjoyable experience..
Venue
Radisson Blu Hotel, Amsterdam: Ideally situated in the historical heart of Amsterdam, close to the main tourist attractions, museums, theatres, shopping areas, red-light and business districts.
The hotel has a fitness center and excellent conference and banqueting facilities.
Address:
Rusland 17, NL-1012 CK Amsterdam, Netherlands
Tel:
+31 20 623 1231
Click on images
Fax:
+31 20 520 8200
to visit the
Hotel’s website
Reservations (email):
[email protected]
Delegates are kindly requested to arrange their own accommodation. Course fees are £1,395.00 (GBP) per delegate. Accommodation is NOT included in the course fees.
(See Page 4 for further details on fees/bookings)
Pharmaceutical Cold Chain & Storage Conditions Qualification – Radisson Blu Hotel, Amsterdam - Course Programme:
Registration (08:30 to 09:00) – Delegates arrive at the meeting room and sign the attendance register. Each day will include at least 1 interactive workshop.
DAY 1 (14 October 2014)
Day 2 (15 October 2014)
Day 3 (16 October 2014)
09:00 Opening/Welcome [Mike James]
Day 2 Introduction (09:00)
Day 3 Introduction (09:00)
Introduction to Controlled Storage and Distribution [Brian
Collins]:
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History of qualification requirements
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The importance of temperature mapping/qualification
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Types of units/facilities and their GMP impact
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Typical distribution chains and the importance of
knowing/understanding your distribution chain and the inherent
challenges involved
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Responsibilities for ensuring compliance during
storage/distribution
Design of Warehouses, Insulated Boxes & Temperature Controlled
Vehicles [Brian Collins]:
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Basic design considerations for warehouses, insulated boxes, and
temperature controlled vehicles:
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To ensure optimum performance
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Temperature monitoring requirements (routine monitoring)
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General points to consider when selecting a warehouse, insulated
box or temperature controlled vehicle
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What can be done to existing facilities, equipment to improve the
level of compliance?
Qualification Overview For Environmental Monitoring Systems
[Mike James]:
 General approach to qualification of EMS systems, including
computerised and hard-wired types
 Typical GAMP related activities for qualification of computer
based systems
 Functionality testing overview
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Based on complexity and risk levels
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Includes functions related to 21 CFR Part 11 compliance
Regulatory Rules & Guidance [Mike James]:
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Overview of all key regulations and standards (explanation of
how they all fit together)
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Areas/regulatory bodies covered:
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EU (includes IMB and MHRA)
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USA (CFRs + FDA Guidance)
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USP 1079
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World Health Organisation (WHO)
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PDA Technical Reports
Monitoring Systems [John Welbourn]:
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Temperature and humidity sensor selection (types available and
their relative performance)
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Mapping systems for qualification studies
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Permanent monitoring systems
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Different type of systems currently available, e.g. RF and
hard-wired
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Advantages and disadvantages
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Load monitoring devices
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Basic principles of data management (under 21 CFR Part 11).
Qualification Requirements [Brian Collins]:
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Validation document platform
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Assessing system impact and component criticality
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System survey and qualification
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Test equipment
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Risk mitigation
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Cold Store Example
Risk Management / Risk Assessments [Mike James]:
 Quality Risk Management overview
 Typical risks associated with the
manufacture/storage/distribution chain
 On-going assessment of risks associated with storage and
distribution systems
 Risk based approach to qualification of equipment
 Performing Quality Risk Analysis to calculating risk scores from
which:
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The level of qualification testing and routine controls can be
derived
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Corrective and preventative measures/actions
commensurate with the level of risk can be applied
Instrumentation Demonstration [Richard Peck]:
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Examples of temperature/humidity loggers
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Features explained, for example:
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Set-up
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Data capture/capacity
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Data reading/storing
 General advise for instrument use based on experience, e.g.
selection, costs, dos and don’ts
Vehicle and Cold Box Qualification/Monitoring [Brian Collins]:
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Equipment used in qualification
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Importance of fully understanding route conditions and realistic
transit times
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Challenges involved in using cold boxes and qualifying them
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Reducing the burden of qualification by using a climatic zone
approach
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Qualification of temperature controlled vehicles
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Using of simulation software to support design and qualification
Design of Fridges, Freezers, Incubators, Cold Stores and
Environmental Chambers [Mike James]:
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Fundamentals of fridge/freezer operation
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Understanding the different types of system and how they
work
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Basic design considerations for compliant and effective
operation
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Temperature monitoring requirements (routine monitoring)
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General points to consider when selecting a fridge, freezer,
incubator or environmental chamber
Temperature Mapping Approaches For Fridges, Freezers and
Incubators [John Welbourn]:
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Types of checking and testing required at various stages of
qualification, e.g. DQ, IQ, OQ and PQ
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Deciding on the type of sensor/data logger to use
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Determining the number and location of sensors
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Typically sensor location/placement maps
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What duration should be used for the mapping studies (at OQ and
PQ)?
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Requirements for empty and loaded state mapping
Finish: 17:15; Drinks Reception: 19:00; Course Dinner: 20:00
Finish: 17:00
Temperature Mapping Approaches For Warehouses and
Cold/Controlled Temperature Stores [Richard Peck]:
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How to decide on the number, type and location of sensors?
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Developing a risk based rationale to support sensor location and
how to prepare a location map
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What should be the duration of the mapping/monitoring?
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The importance of sound data management practices
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Activities undertaken at various qualification stages
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When to install a permanent monitoring system (before, during or
after qualification studies)?
Course Closure
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Questions and answers
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Course evaluation
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Certificates
Finish: 16:20
BOOKING DETAILS: Pharmaceutical Cold Chain & Storage Conditions Qualification - 14, 15 & 16 October 2014
Radisson Blu Hotel, Amsterdam
How to book on this course:
• The simplest and quickest way is to book online. Please visit/return to the CVS web-site, find the course you are interested in and follow the simple instructions (link
included below).
• Alternatively, download a booking form, complete it electronically or print and annotate, and return it to us by fax or email (link and contact details included below).
• Or finally, print out this page, complete the form below by hand and return by fax, email or post.
<< CLICK HERE TO GO TO CVS WEBSITE >>
Fax: +44 (0)1625 800833
<< CLICK HERE FOR BOOKING FORM >>
Tel: +44 (0)1625 500833 or +44 (0)1270 760882
Alternative Booking Form (‘*’ indicates required fields)
*Booking Contact Name:
*Booking Contact E-mail Address:
*Company Name & Address:
*Billing Address
(Only complete if different to Company Address)
*Number of Delegates:
*Delegate Name(s):
(if different to booking contact)
Delegate E-mail Address(es):
(if different to booking contact)
Special dietary requirements?
Disability Requirements?
Company VAT Number (or Sales Tax
Number) – *EU Countries Only
*Method of payment, e.g. card, bank
transfer or cheque
NOTE: For card payments by telephone, please ensure you have entered
your telephone number above and we will contact you. Alternatively, call
+44 (0)1625 500833 to make your payment. Cheques should be sent with
a completed booking form to Compliance & Validation Services Limited, 8
Sedgefield Close, Macclesfield, Cheshire, SK10 2WF, United Kingdom.
Payment Reference (if available)
NOTE: For bank transfer payments we will need a valid reference number
or purchase order number to fully confirm the booking.
* Total Fees Due
NOTE: If your finance centre or delegates are based in the United Kingdom
(UK), the course fee will be subject to an additional 20% UK VAT charge
(£1674 per delegate including UK VAT).
For EU Countries where finance centres and delegates are NOT based in
the UK, VAT will be ZERO RATED under the reverse charge rule.
For non-EU countries and non-EU delegates, VAT is not applicable.
£1,395 [GBP] per delegate
E-mail: [email protected]
Booking Terms & Conditions
Booking Confirmation: A booking confirmation will be sent to the
delegate or booking contact on receipt of payment, or in the case of bank
transfer, following receipt of a valid purchase order reference.
Course Fee & VAT Liability: For the majority of participating countries,
VAT will be ZERO rated or not applicable. However, for companies whose
finance centre is based in the United Kingdom (location where invoices are
managed) or delegates are UK based, the indicated course fee will be
subject to an additional 20% UK VAT charge. CVS has to charge this by
law. For EU Countries where finance centres and delegates are NOT
based in the UK, VAT will be ZERO RATED under the reverse charge rule.
For non-EU countries and non-EU delegates, VAT is not applicable.
All participating EU based companies (based on the site location), must
provide CVS with a valid VAT/Sales Tax reference number, in order for the
booking to be completed. CVS is required by law to collect this information.
Cancellation: Cancellation refunds will depend on how long before the
course start date the cancellation is received. The following refund
structure will apply, based on the date the cancellation is received by CVS:
•
More than 28 days will incur a cancellation fee of £200 GBP per
registration and qualify for a refund of the remaining course fees
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Between 28 days and 14 days notice will qualify for a 75% refund
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Between 14 days and 7 days notice will qualify for a 50% refund
•
No refund will be given for cancellations received with less than 7
days notice
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Substitutions for registered delegates will be accepted without
notice
CVS reserves the right to cancel or reschedule any course and/or change
presenters. Please be advised that CVS is not responsible for any airfare
and/or hotel penalties or other travel charges that delegates may incur.
Where government intervention, military activities, natural phenomenon,
strikes or any other circumstances make it impossible or inadvisable to run
the course at the designated time and place, the delegate shall waive any
claim for damages or compensation except the amount paid for registration
after the deduction of actual expenses incurred by CVS in connection with
the course that the delegate has registered for and there shall be no future
liability on the part of either party.
Please visit our web site for full terms and conditions (see the link at the
top of this page).
Please note that by completing the booking form (opposite) you are
agreeing to our Terms and Conditions.