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

Event Details

Time: December 10, 2015 at 9am to December 11, 2015 at 6pm
Location: Hilton Sydney, 488 George Street, Sydney, Australia 2000
Street: Sydney, Australia
City/Town: Sydney, Australia
Website or Map: http://bit.ly/1RyDJCh
Phone: 18004479407
Event Type: seminar
Organized By: NetZealous LLC, DBA GlobalCompliancePanel
Latest Activity: Nov 10, 2015

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Event Description

Overview:

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrates that they struggle with either understanding or implementing the regulations.

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 report. 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 records
Full Set of Qualification examples for an HPLC system Full set of Validation examples of a chromatographic Data System

Why should you attend?

Learn about the regulatory background and requirements for equipment qualification according to USP <1058>, computer system validation according to GAMP Guides
Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
Be able to explain the difference between equipment calibration, qualification and system validation
Understand and Implement the new UK MHRA GMP Data Integrity Guideline
Learn which equipment/systems need to be qualified or validated
Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordingly
Understand the logic and principles of instrument qualification and system validation from planning to reporting

Location: Sydney, Australia Date: December 10th and 11th, 2015 Time: 9 AM to 6 PM

Venue: Hilton Sydney

Address: 488 George Street, Sydney, Australia 2000

Price: $1,695.00 (Without stay)

Until November 15, Early Bird Price: $1,695.00

From November 16 to December 08, Regular Price: $1,895.00

Price: $2,095.00 (With stay)

Until November 15, Early Bird Price: $2,095.00

From November 16 to December 08, Regular Price: $2,295.00

Registration Details:

NetZealous LLC - DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA