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For Industry Professionals

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Module 1: Regulations and guidances governing CSV

Module 2: GAMP 5 and Good Practice Guides

Module 3: Computerized Systems and their validation  
ERP Systems  
Process Control Systems  
Laboratory Computerized Systems  
IT Infrastructure  
Clinical Trial Applications and Statistical Softwares  
Spreadsheets

Module 4: Documentation for Computerized System Validation

Module 5: Maintaining Compliance

Training materials
Participants shall receive a copy of the presentation(s), relevant notes and workshop materials.
A certificate of completion shall be issued to participants who successfully complete the assessment.

Course Format
For students and academicians, the modules shall be covered as a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

For industry professionals, on site training as well as training programs shall be conducted which shall be updated regularly.

For more details, write to us on regulogix@gmail.com



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   ERP Systems
   Laboratory Computerized Systems
   Process Control Systems
   Infrastructure Qualification
   Clinical Trial Applications/ Statistical Softwares/ Pharmacokinetic Applications
   21 CFR Part 11 System Assessment and GAP Analysis
For Students
For Industry Professionals
Computerized System Validation
   ERP Systems
   Laboratory Computerized Systems
   Process Control Systems
   Infrastructure Qualification
   Clinical Trial Applications/ Statistical Softwares/ Pharmacokinetic Applications
   21 CFR Part 11 System Assessment and GAP Analysis
Spreadsheet Development and Validation
Regulatory Services
Temperature Mapping
Training
   For Students
   For Industry Professionals
SOP Preparation and Implementation
Upcoming Services