21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud
Training
In Mumbai
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JRD Global EDU
Course Online₹ 12,700 -
Khagolam Institute of Geoinformatics
Certificate Maharashtra / Classroom-based₹ 25,000 -
CAE e-learning
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LearnCAx
Certificate OnlinePrice on request -
Chhattisgarh University
Master Distance learningPrice on request -
Distance Learning Programs
Course Distance learningPrice on request -
PCS India - Precise Cosultancy Services
Post Graduate Diploma Distance learning₹ 18,800 + VAT
Description
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Type
Training
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Level
Advanced
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Location
Mumbai
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Class hours
9h
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Duration
2 Days
Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
Facilities
Location
Start date
Start date
About this course
Course Objectives
Understand what is expected in Part 11 and Annex 11 inspections
Avoid 483 and Warning Letters
Learn how to buy COTS software and qualify vendors.
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe
QA, IT, management
all GxP system users
Reviews
Subjects
- Compliance
- Fda
- 21 CFR Part 11/Annex 11
- Compliance for Electronic Records and Signatures
- Five Keys to COTS Computer System Validation
- 21 CFR Part 11 compliance
- Software validation
- Data Integrity
- Electronic records and signatures
Teachers and trainers (1)
David Nettleton
Director & FDA Compliance Specialist
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" that 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 185 mission critical software validation projects.
Course programme
Lecture 1: Introduction to the FDA
- How the regulations help your company to be successful
- Which data and systems are subject to Part 11
Lecture 2: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
- What Part 11 means to you, not just what it says in the regulations
- Avoid 483 and Warning Letters
- Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
- How SaaS/cloud computing changes qualification and validation
- Ensure data integrity, security, and protect intellectual property
- Understand the current computer system industry standards for security, data transfer, and audit trails
- Electronic signatures, digital pens, and biometric signatures
- SOPs required for the IT infrastructure
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
Lecture 3: The Five Keys to COTS Computer System Validation
- The Who, What, Where, When, and Why of CSV
Lecture 1: Ten-Step Process for COTS Risk-Based Computer System Validation
- Learn which documents the FDA expects to audit.
- How to use the risk-based validation approach to lower costs.
- How to link requirements, specifications, risk management, and testing.
- Document a computer system validation project using easy to understand fill-in-the-blank templates.
- Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).
Lecture 2: How to Write Requirements and Specifications
- Workshop for writing requirements and then expanding them for specifications
Lecture 3: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
Lecture 4: Software Testing
- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases
Lecture 5: System Change Control
- How to manage a validated system with minimal documentation
Lecture 6: Purchasing COTS Software
- How to purchase COTS software and evaluate software vendors.
Lecture 7: Cost Reduction Without Increasing Regulatory or Business Risk
- How to save money
- How to increase quality
- How to increase compliance with less documentation
Additional information
21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud
-
JRD Global EDU
Course Online₹ 12,700 -
Khagolam Institute of Geoinformatics
Certificate Maharashtra / Classroom-based₹ 25,000 -
CAE e-learning
Course Online₹ 1,083 + VAT -
LearnCAx
Certificate OnlinePrice on request -
Chhattisgarh University
Master Distance learningPrice on request -
Distance Learning Programs
Course Distance learningPrice on request -
PCS India - Precise Cosultancy Services
Post Graduate Diploma Distance learning₹ 18,800 + VAT