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Event
21 Apr 2016
Science

Sydney Seminar on Validation and Part 11 Compliance of Computer Systems and Data

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.The 2-day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.Additional Bonus Material for easy implementation:70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)10 SOPs related to validation and qualification of analytical equipment and computer systems. change control, risk assessment, maintenance, security and integrity of electronic recordsFull Set of Qualification examples for an HPLC system Full set of Validation examples of a chromatographic Data SystemLocation: Sydney, Australia Date: April 21st & 22nd, 2016 and Time: 9:00 AM to 6:00 PM Venue: Hilton SydneyAddress: 488 George Street, Sydney, Australia 2000Price: Register now and save $200. (Early Bird)(Without Stay) Price: $1,695.00 (Seminar for One Delegate) (With Stay) Includes Price: $2,095.00 (Seminar for One Delegate)Until March 10, Early Bird Price: $1,695.00 from March 11 to April 19, Regular Price: $1,895.00Until March 10, Early Bird Price: $2,095.00 from March 11 to April 19, Regular Price: $2,295.00Quick Contact:NetZealous DBA as GlobalCompliancePanel  Phone: 1-800-447-9407Fax: 302-288-6884

When

21 Apr 2016 @ 09:00 am

22 Apr 2016 @ 06:00 pm

Duration: 1 days, 9 hours


Where

Hilton Sydney

488 George St

Australia


Language

English en


Organised by

GlobalCompliancePanel (deactivated)

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