2-day In-person Seminar on Validation and Part 11 Compliance of Computer Systems and Data at Mumbai, India

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.

Agenda:

Day One

Lecture 1: Requirements and approaches for Analytical Instrument Qualification and Computer System Validation

Lecture 2: Going through the equipment qualification phases

Lecture 3: Dealing with specific USP <1058> requirements

Lecture 4: Cost Effective Validation of Laboratory Computer Systems: Step-by-Step

Day Two

Lecture 1: Maintaining the validated State of computer systems

Lecture 2: Validation and Use of Excel Spreadsheet applications

Lecture 3: Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11

Lecture 4: Ensuring and documenting Integrity of Laboratory (Raw) data and other Records

Location: Mumbai, India   Date: December 3rd and 4th, 2015 Time: 9 AM to 6 PM 

Venue: The LaLiT Mumbai 

Address: Sahar Airport Road, Andheri East, Mumbai – 400059, MH

Price: INR 14,000 (Seminar for One Delegate)

Until November 15, Early Bird Price: INR 14,000

From November 16 to December 01, Regular Price: INR 16,000

Registration Details:

NetZealous  - GlobalCompliancePanel

NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, 
Bangalore - 560078 Karnataka, INDIA

Phone:  1800 425 9409 

Fax:  080-25149544 

customersupport@globalcompliancepanel.com

http://www.globalcompliancepanel.in/

Registration Link - http://www.globalcompliancepanel.in/control/validation-part-11-compliance