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
