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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.
Additional Bonus Material for easy implementation:
Why should you attend?
Companies and Departments:
Who Will Benefit:
Requirements and approaches for Analytical Instrument Qualification and Computer System Validation
Going through the equipment qualification phases
Dealing with specific USP requirements
Cost Effective Validation of Laboratory Computer Systems: Step-by-Step
Maintaining the validated State of computer systems
Validation and Use of Excel Spreadsheet applications
Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
Ensuring and documenting Integrity of Laboratory (Raw) data and other Records
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: â‚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
NetZealous BDA as GlobalCompliancePanel
Registration Link - http://bit.ly/Validation-and-Part-11-Compliance-of-Computer-Systems