Seminar on Validation and Part 11 Compliance of Computer Systems and Data at Zurich, Switzerland

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 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.

Speaker:

Dr. Ludwig Huber, Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. 

Venue: Hilton Zurich Airport

Hotel Address: Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland.

Little Switzerland, NC 28749

Date: October 6th & 7th 2015

Time: 9:00 AM to 6:00 PM

Price: $1,595.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird) Until August 15, Early Bird Price: $1,595.00 From August 16 to October 04, Regular Price: $1,795.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Registration Link: https://goo.gl/aYhqQO