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

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. 

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

Companies and Departments:

• Pharmaceutical development and Quality control laboratories
• Quality control laboratories of API manufacturers
• Contract laboratories
• Clinical Research Organization
• Suppliers of analytical instruments and laboratory computer systems

Who Will Benefit:

• IT/IS managers and System Administrators
• QA Managers and Personnel
• Laboratory Managers and Supervisors
• Analysts
• Validation Specialists
• Software Developers
• Regulatory Affairs
• Training Departments
• Documentation Departments
• Consultants

Speaker:

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". 

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: ₹ 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: customersupport@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.in

Registration Link - http://bit.ly/Validation-and-Part-11-Compliance-of-Computer-Systems