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Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA
Singapore, Singapore 5 – 6 December / 2013
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About the conference
1. This course will teach you how to reduce software validation costs by as much as two thirds.
2. It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.
3. The course is highly interactive, using real life examples and proven techniques.
4. You will learn how to use electronic records and electronic signatures to maximize productivity.
5. 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.
6. 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.
7. Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.
Who Will Benefit:
· Laboratory staff
· Regulatory Affairs
· GMP, GCP, GLP professionals
Day 1 - Agenda
Lecture 1: Introduction to the FDA
Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
Lecture 3: HIPAA Compliance for Electronic Records
Lecture 4: The Five Keys to COTS Computer System Validation
Lecture 5: The Validation Team
Day 2 - Agenda
Lecture 6: Ten-Step Process for COTS Computer System Validation
Lecture 7: How to Write Requirements and Specifications
Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Lecture 9: Software Testing
Lecture 10: System Change Control
Lecture 11: Cost Reduction without Increasing Regulatory or Business Risk
Lecture 12: Q & A
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.