Course Overview:
Your company relies heavily on computer systems for its operations. With advancing technology and the industry’s focus on “data integrity” (ensuring availability, authenticity, accuracy, and traceability of information), computerized systems are being adopted at a greater pace. In turn, regulatory bodies like TGA, FDA, and Medsafe are intensifying their scrutiny on computer system validation. Therefore, a risk-based approach to system validation is essential to achieve compliance. This course will equip you with critical insights into the validation of computerized systems, enabling your company to meet regulatory expectations while mitigating risks to product quality and patient safety.
Course Outline:
Day 1:
• Regulations and GAMP
o Definition of validation as applied to computerized systems
o Regulatory status and PIC/S
o Introduction to the Principles of CSV
o GAMP
• SDLC, Data Integrity and Risk Assessment
o System Life Cycle Approaches
o Development Models
o More Principles of CSV
o Mapping into Company Procedures
o Data Integrity
o Risk Assessment for Computerized Systems
• IT Infrastructure Qualification and Planning Phases
o IT Infrastructure Qualification / Validation
o Validation Master Planning
o Legacy System Validation
o Generating an Inventory of Systems
o Validation Protocol
o Spreadsheet Validation
o Validation Plan
o Cross Functional Plans
Day 2:
• Pre-Development Phases
o Requirements Definition
o Traceability
o Audits
o Design
• Development, Testing, Qualification and Use
o Coding
o Testing
o Qualification
o Decommissioning
• Electronic Records / Signatures – Cloud Computing
o Detailed interpretation of Part 11
o Implications for computerized systems in applying Electronic Records and Signatures
o Applying principles to new and existing Systems
o Reviewing Example Scenarios
o Understand Cloud Computing Implications
Participants
You will benefit from this course if you are a key Quality, IT or Operational Subject Matter Expert (SME) or Manager likely to be involved in using, validating, approving, or purchasing computer systems.