21 CFR Part 11: Computer System validation Training CD Bundle
This high-value packaged course has been created exclusively to benefit professionals working in the life sciences sector in India.
upon purchase, the training CDs of the 4 modules will be couriered to your location. The package includes the following 4 modules:
- Computer System Validation: Step-by-Step (75 mins)
- Validation and Use of Cloud Computing in FDA Regulated Environments (75 mins)
- Learning from Recent FDA Warning Letters Related to Part 11 and Computer System Validation (75 mins)
- Validation and Use of Excel® Spreadsheets in FDA Regulated Environments (75 mins)
If you interested in purchasing individual modules at special rates, please fill in the inquiry form or email to [email protected]
Module 1: Computer System Validation: Step-by-Step
Areas Covered in the module:
- US FDA and EU requirements and enforcement practices
- Learning from recent FDA 483s and Warning Letters
- Selecting the right validation model: qualification vs. verification
- Eight fundamental steps for computer system validation
- Structure and example of a validation plan
- Justification and documentation of risk levels
- Examples of qualification document for suppliers of commercial systems
- Examples for requirement and functional specifications
- Example for IQ protocols
- OQ test protocols: development, execution, approval - examples
- Documentation of ongoing performance
- Validation of existing systems
- Structure and example of a validation report
- Step-by-step case studies from laboratories and manufacturing units for easy implementation
Hand-outs:
For easy implementation, attendees will receive:
- SOPs: Validation of Commercial Off-the-Shelf Computer Systems
- SOP: Development and Maintenance of Test Scripts for Software and Computer Systems
- Checklist: Using Computers in FDA Regulated Environments
Module 2: Validation and Use of Cloud Computing in FDA Regulated Environments
Areas Covered in the module:
- Benefits of virtual networks and cloud computing
- Possible issues when used in FDA regulated environments
- Recommendations from official task forces
- Different models: infrastructure, platform and software as a service
- Recommendations for different cloud versions: internal/external private, public
- Validation of cloud vs. traditional computers
- How to deal with major issues: security, data availability and data integrity
- Going through a complete project for cloud computing validation
- Selecting the right cloud provider for compliance
- What and how much to test and documents for different cloud models
- Considerations for formal agreements with service providers
- Step-by-step recommendations for using 'clouds' from planning to reporting
- Putting everything together: documentation for the FDA and every other agency
- Sharing best practices
Hand-outs:
For easy implementation, attendees will receive:
- SOP: Using Cloud Computing in Regulated Environments
- SOP: Using the Internet in Regulated Environments
- SOP: Qualification of Virtual Networks
Module 3: Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation
Areas Covered in the module:
- FDA inspections - preparation, conducts, follow up
- The meaning of Warning Letters and 483 inspectional observations
- Learning from an FDA presentation: Data Integrity and Fraud - Another Looming Crisis?
- Data integrity and authenticity: FDA's new focus during inspections
- Examples of recent Part 11 related 483s and Warning Letters
- Examples of recent 483s and Warning Letters related to computer system validation
- Most obvious reasons for deviations
- Avoiding and responding to 483s: going through case studies
- Writing corrective and preventive action plans as follow up to 483s
- Using internal audits to prepare yourself for Part 11 related FDA inspections
- Strategies and tools for compliant Part 11 implementation
- The future of Part 11 and computer system validation
Hand-outs:
For easy implementation, attendees will receive:
- Checklist: Part 11 compliance
- Case studies: How to avoid Part 11 related 483s and Warning Letters
- SOP: Electronic audit trail - specifications, implementation, validation
Module 4: Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Areas Covered in the module:
- FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
- How to design spreadsheets for Part 11/GxP/SOX/HIPAA compliance?
- Validation during design, development, installation and on-going use.
- When, what and how much to test?
- Dealing with standard Excel functions: Recommendations from GAMP5.
- How to ensure and validate spreadsheet integrity and security for GxP and Part 11?
- How to apply risk based validation to spreadsheet applications?
- Validation of 'ad hoc' spreadsheet applications.
- How to document planning, specifications, installation, testing and changes?
- Examples from manufacturing, laboratories and offices
Hand-outs:
For easy implementation, Attendees will receive:
- User Manual with Excel functions that help to comply with FDA requirements
- SOP: Validation of spreadsheet applications
- SOP: Development and use of spreadsheets in regulated environments
- Gap analysis/checklist for Macros and Spreadsheet applications
- Examples for validation documents
Note: The complimentary hand-outs for each of the above modules will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.
For more information or assistance, please email [email protected] or call +1 650-620-3937
