ComplianceOnline

21 CFR Part 11: Computer System validation Training CD Bundle



Price: $345.00
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 ob-int@complianceonline.com


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 customercare@complianceonline.com 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 ob-int@complianceonline.com or call +1 650-620-3937

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