Validation and Part 11 Compliance of Computer Systems and Data Seminar in Mumbai
About This Event
Overview:
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
Chief Advisor - Global FDA compliance, Agilent Technologies
Dr. Ludwig Huber, Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber's website www.ludwig-huber.com
Date: April 28th & 29th, 2016 Time: 9 AM to 6 PM
Venue Name & Address: The LaLiT Mumbai
Sahar Airport Road, Andheri East, Mumbai, Maharashtra – 400059
Price: ¹ 14,000
Register now and save 2000 (Early Bird)
Until March 15, Early Bird Price: 14,000 from March 16 to April 26, Regular
Price: 16,000
Contact Address:
NetZealous BDA as GlobalCompliancePanel
Phone: 080-32528001
Fax: 080-25149544
Email: [email protected]
Website: http://www.globalcompliancepanel.in
Registration Link - http://bit.ly/Validation-and-Part-11-Compliance-of-Computer-Systems