21 CFR Part 11: Computer System validation Training CD Bundle

Product Details

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