Singapore Training
Instructor: Gordon Farquharson, BSc (Hons), CEng Principal Consultant, Bovis Lend Lease
18 - 19 March 2009
08.30 - 09.00 Registration 09.00 - 17.00 Training Time
NUS Extension
Singapore
March 2009
Pharmaceutical Water Systems Regulation, Purification, Distribution and Validation
Pharmaceutical Water SystemsRegulation, Purification, Distribution and Validation
is the Society of choice for more than 25,000 pharmaceutical manufacturing professionals in 90 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge,
exchange practical experience, and collaborate with global regulatory agencies. Visit www.ISPE.org for Society news and more information.ISPE
Description
Review the principles of design and operation of water systems used directly in pharmaceutical manufacturing, including the fundamental concepts and principles for systems used to generate, store and distribute both compendial and non-compendial waters. These concepts include specification, design, installation, operation, testing, validation and maintenance of components and systems. Also examine methods for proper water quality selection and receive detailed guidance regarding the choice and use of appropriate construction materials and instrumentation. The course covers both US and European regulatory requirements (compendia, current good manufacturing practices and regulatory guides) and explores typical concerns of the regulator.
Participants will receive a complimentary copy of the Water and Steam Systems Baseline® Guide and the Good Practice Guide: C&Q of Water and Steam.
Take Back to Your Job Ways to ...
• Differentiate regulatory requirements from myths relative to water generation, distribution and storage systems
• Identify alternative system designs and their advantages and disadvantages
• Understand the importance of microbiological control and analyse the principles behind water system testing and qualification
• Understand the impact of water quality requirements (compendial and non- compendial) on water system operations
• Define the basic requirements for water distribution system component installation and overall system construction
• Integrate and streamline commissioning and validation activities
Who Should Attend
• Pharmaceutical professionals who are new to water treatment systems or those with significant engineering expertise from another industry who need to learn about pharmaceutical water treatment systems
• Those with significant industry experience in other capacities that now have water generation system engineering and/or maintenance responsibilities and want to gain a fundamental understanding of the requirements for designing, building, operating, testing, and maintaining these systems
• Water treatment systems quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water generation systems
• Professionals who are new to pharmaceutical water distribution systems
• Those with significant engineering expertise from another industry who need to learn about pharmaceutical water distribution systems
• Quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, validation personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water systems
Gordon
Farquharson, BSc
(Hons), CEng, is a
Chartered Consulting
Engineer with 30
years of experience
in quality and safety critical processes
and facilities used by industries such as
healthcare, life science, micro-electronics,
etc. He is Principal Consultant with
Bovis Lend Lease Technology Division’s
global operation. Farquharson has been
responsible for the development of
technical solutions in discovery, research,
product/process development, primary
manufacturing, and device and dosage
form manufacturing. Standards and
regulatory compliance in the sector are a
significant interest and responsibility. He
is chairman of UK BSI and CEN Technical
Committees for cleanroom standards, and
convenor of the ISO working group that is
revising ISO 14644-1 and 2. He recently
represented ISPE and CEN, working on
the EMEA’s revision of Annex 1 of the
EU GMP. He also supported ISPE by
writing WHO’s new Pharmaceutical Water
GMP Guidance, and has been active
developing and revising ISPE Baseline®
Guides. Farquharson is a past chair of the
ISPE European Education Committee and
current member, a founder of the Sterile
Products Processing COP, and was voted
ISPE Member of the Year in 2001. He is
a frequent speaker and trainer for ISPE
worldwide.
About the Instructor
Registration Course Fee Includes: • Course materials • Morning and afternoon tea/coffee • Lunch
Registration Fees (in Singapore Dollars)
By 25 February
ISPE Members: S$1000Nonmembers: S$1350 Academia Member: S$500After 25 February ISPE Members: S$1200Nonmembers: S$1550 Academia Member: S$600
This nonmember rate entitles you to a one-year membership in ISPE at no additional charge.
Please contact Janet Hedges, Singapore Affiliate Manager, by email at [email protected] for information on discounts for groups, academia members, developing nations or government. Space is limited to 30 attendees; therefore registration is on a first-come, first-served basis.
Payment must be included with the registration form and returned by mail. Please make cheques payable to “International Society for Pharmaceutical Engineers (Singapore).” Credit cards will not be accepted. Payment must be submitted at least one (1) week prior to the event. All prices are in Singapore dollars.
Training Course Venue
NUS Extension 9 Penang Road#12-01, Park MallSingapore 238849Tel: 65 6338 8400Fax: 65 6338 7619
Cancellations
Cancellations must be made in writing. If cancellations are received two (2) weeks prior to the course, a full refund, minus a S$75 handling fee, will be issued. After that time, no refunds will be granted. If the registrant is unable to attend, substitutions will be accepted.
Accommodations
Hotel stay is not included with course registration. Please contact Janet Hedges by email, [email protected], for more information on accommodations near the training course venue.
Special Requirements
If you require special accommodations to fully participate, such as a wheelchair-accessible room or a sign language interpreter, please attach a written description of your needs. If you have questions, please contact Janet Hedges by email at [email protected].
Notice
The instructors engaged to present these programs are leading professionals in their fields. However, in rare circumstances, it may be necessary to make substitutions; every possible effort will be made to replace instructors with those of comparable qualifications. Agendas are subject to change without notice. Every precaution is taken to ensure accuracy, but ISPE cannot accept responsibility for the accuracy of information distributed or contained in these programs or for any opinion expressed. ISPE is not responsible for lost airfare due to cancellations.
Temperatures in meeting rooms tend to be chilly, please bring a jacket or light sweater.
Participant’s name and address may be given as part of a list to other organizations for purposes related to the pharmaceutical manufacturing field. If you do not wish to receive other related information, please tick the appropriate box on the registration form.
Please visit
www.ISPE.org/singapore to view the complete conference registration and cancellation policies.
General Information
Hotel Accommodations
For assistance in booking your hotel accommodation, please contact Janet Hedges, Singapore Affiliate Manager, at [email protected] or tel 65 6826 1105.
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CouRSE DATE MEMbER FEES nonMEMBER FEES* ACADEMIA MEMBER FEES
18-19 March 08.30-09.00 Registration 09.00-17.00 Training Time
By 25 February S$1000 After 25 February S$1200
By 25 February S$1350 After 25 February S$1550
By 25 February S$500 After 25 February S$600
Course Rates
ISPE Singapore Training Registration:
Pharmaceutical Water SystemsRegulation, Purification, Distribution and Validation
www.ISPE.org/singapore
Sing-March09-I
Please return completed form and bank cheque to:
Janet HedgesISPE Singapore Affiliatec/o 73 Bukit Timah Road#03-01 Rex HouseSingapore 229832Tel: 65 6826 1105 Fax: 65 6377 0879 Email: [email protected]
Please make cheques payable to “International Society for Pharmaceutical Engineers (Singapore).”
Credit cards or telegraphic transfers (TT) will not be accepted.
Payment must be submitted at least one (1) week prior to the event. All prices are in Singapore dollars.
Payment and Registration Submission
*BECOME AN ISPE MEMBER: Yes, I wish to join ISPE today at no additional charge! Please download a membership application at www.ISPE.org/membership. Membership is for a one-year period and is non-transferable.
