Seminar on Validation and Part 11 Compliance of Computer Systems and Data at Hong Kong

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 demonstrate 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.

Location: Hong Kong Date: December 7th and 8th, 2015 Time: 9 AM to 6 PM 

Venue: INTERCONTINENTAL HONG KONG

Address:  18 Salisbury Road, Kowloon, Hong Kong

Price: $1,695.00 (Without stay)

Register now and save $200.

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

 From November 16 to December 05, Regular Price: $1,895.00

Price: $2,095.00 (With stay)

Register now and save $200.

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

From November 16 to December 05, Regular Price: $2,295.00

Registration Details:

NetZealous LLC - DBA GlobalCompliancePanel

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

USA Phone: 1-800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com  

http://www.globalcompliancepanel.com

Registration Link -  http://bit.ly/1WeUzYf