Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA

Overview:
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:
• IT
• QA
• QC
• Laboratory staff
• Managers
• Regulatory Affairs
• GMP, GCP, GLP professionals
Course Description:
Day 1 – Agenda
1. Lecture 1: Introduction to the FDA
2. Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
3. Lecture 3: HIPAA Compliance for Electronic Records
4. Lecture 4: The Five Keys to COTS Computer System Validation
5. Lecture 5: The Validation Team
Day 2 – Agenda
1. Lecture 6: Ten-Step Process for COTS Computer System Validation
2. Lecture 7: How to Write Requirements and Specifications
3. Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
4. Lecture 9: Software Testing
5. Lecture 10: System Change Control
6. Lecture 11: Cost Reduction without Increasing Regulatory or Business Risk
7. Lecture 12: Q & A

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Overview:
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:
• IT
• QA
• QC
• Laboratory staff
• Managers
• Regulatory Affairs
• GMP, GCP, GLP professionals
Course Description:
Day 1 – Agenda
1. Lecture 1: Introduction to the FDA
2. Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
3. Lecture 3: HIPAA Compliance for Electronic Records
4. Lecture 4: The Five Keys to COTS Computer System Validation
5. Lecture 5: The Validation Team
Day 2 – Agenda
1. Lecture 6: Ten-Step Process for COTS Computer System Validation
2. Lecture 7: How to Write Requirements and Specifications
3. Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
4. Lecture 9: Software Testing
5. Lecture 10: System Change Control
6. Lecture 11: Cost Reduction without Increasing Regulatory or Business Risk
7. Lecture 12: Q & A

5 Dec - 6 Dec 2013
Singapore
Singapore
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