Computer System Validation - CSV

Computer System Validation - CSV

 

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About The Event

Introduction:
A Course designed to completely engage you in Computer system Validation for the present Needs. This Course delivers Hands on experience knowledge on how CSV is treated and looked at in the present times. You will be ready for how to select the right validations and right controls (Technical and Procedural) Know how on handling PLC's.
 
Challenges:
  • Data Integrity with Documentation
  • Identifying right and appropriate Procedural and Technical controls
  • How Agile methodology works for Cat 5 development

Learning Objectives:

  • Role of FDA
  • CSV Points and why Validate
  • GAMP
  • Relation between 21 CFR Part 11, Annex 11 and 211
  • Risk Assessments
  • Data Integrity
  • CSV Deliverables (Technical and Procedural controls)
  • How to have an SOP and benefits and following the SOP's
Compliance Challenges:
The confusion due to what are often contrary interpretations of CSV requirements, the focus on generating extensive CSV packages, and fear of not meeting regulatory expectations turn many CSV projects into major endeavors that lose sight of the contribution to quality and compliance. A harmonized and consistent risk-based CSV is an effective way to optimize the investment allocated to corporate compliance programs.
 
Target Audience:
A must attend the seminar for professionals in Pharmaceuticals, QC Laboratories, APIs, Finished Products, Contract Laboratories, CROs, Medical Device & Biotech companies, and Suppliers of Computer Systems. DEPARTMENTS: Quality Control & Quality Assurance, Research and Development, Laboratory and Regulatory Compliance, IT/IS & Software Departments, Production & Manufacturing, Documentation, Training Departments PROFESSIONALS: Managers and Supervisors, Senior Managers and Team Leaders, General Managers, Analytical Chemists, Validation Specialists, Laboratory Managers and Supervisors, Regulatory Affairs Managers, Documentation Specialists & Analysts, Consultants, and Systems Administrators

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