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01 Jul 2013

Software Validation for the New FDA Inspections

2-day In-person Seminar on Software Validation for the New FDA Inspections at Hotel Lalit, Mumbai

Overview:This course will teach you how to reduce software validation costs by as much as two thirds.It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.The course is highly interactive, using real life examples and proven techniques.You will learn how to use electronic records and electronic signatures to maximize productivity.This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation.Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.Who Will Benefit:ITQAQCLaboratory staffManagersRegulatory AffairsGMP, GCP, GLP professionalsAbout Speaker - David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.  He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects.


1 Jul 2013 @ 09:00 am

2 Jul 2013 @ 06:00 pm

Duration: 1 days, 9 hours


The Lalit Hotel Sahar Airport, Andheri East





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GlobalCompliancePanel (deactivated)