This is a fundamental course with examples covering:

• What is Data Integrity?
• Associated regulatory requirements and guidelines
• What is data and process lifecycle?
• Identifying data quality
• Awareness of DI impact on CSV
• Introduction to DI compliance approach

Training Objective:
To be able to outline the rationale of DI, data and process lifecycle, and assess data quality of different regulated records.

Duration:
Half Day

Target Audience:
This course is designed for personnel responsible for creating, processing, reviewing, and securing of regulated data (i.e. System Users, Data Officer, Data Reviewer, QA, CSV, IT, Document Archivist, etc.), as well as those interested in the topics and seeking to remain current with industry trends and approaches.

This is a comprehensive and interactive course covering:

• DI Overview
• DI Risks
• DI implementation Strategies
• Maintaining DI compliance

Training Objective:
To be able to evaluate and apply appropriate DI methodology to achieve and maintain DI compliance.

Duration:
1 Day

Target Audience:
This course is designed for experienced personnel (equipped with basic DI knowledge) who are responsible for establishing DI programs, DI risk assessment, or involved in DI task force (i.e. data officer, data steward, document controller, process owner, IT, validation, quality, etc.)

This is a fundamental course with examples covering:

• What is Computerized System Validation?
• Associated regulatory requirements and GAMP guidelines
• Categorization of Computerized system
• Practical concept of CSV Lifecycle and deliverables
• The importance of validating as per intended use
• Awareness of DI and Cybersecurity consideration

Training Objective:
To be able to outline GAMP concept and deliver according to defined CSV strategy meeting site and regulatory requirements.

Duration:
Half Day

Target Audience:
This course is designed for personnel responsible for CSV (i.e. system owner, process owner, IT, Validation, Quality, etc.), as well as those interested in the topics and seeking to remain current with industry trends and approaches.

This is an in-depth and interactive course covering

• Validation quality attributes
• Risk Based Approach
• Robust validation lifecycle
• Concept of system boundary and family approach
• Deviation and Change Management
• Effective approval

Training Objective:
To be able to assess and strategize an effective and efficient approach in CSV meeting site and regulatory expectations.

Duration:
1 Day

Target Audience:
This course is designed for experienced personnel responsible for CSV (i.e. system owner, process owner, IT, Validation, Quality, etc.), as well as those interested in the topics and seeking to remain current with industry trends and approaches.

This is an advanced course and interactive course covering:

• DI, 21 CFR part 11, Cybersecurity
• Process and Data Flow
• CSV deliverables impacted by DI
• Maintaining DI and Validated state

Training Objective:
To be able to identify, evaluate and implement DI requirements within CSV to meet DI regulatory expectation.

Duration:
1 Day

Target Audience:
This course is designed for experienced personnel responsible for CSV (i.e. system owner, process owner, IT, validation, quality, etc.), as well as those interested in the topics and seeking to remain current with industry trends and approaches.

This is a hands-on practice workshop covering:

• Development of key CSV deliverables
• Deviation Handling
• Change Control Handling

Training Objective:
To be able to adopt good writing practice and perform effective review of CSV deliverables, optimal deviation handling and proper change control.

Duration:
2 Day

Target Audience:
This workshop is designed for experienced personnel responsible for CSV (i.e. system owner, process owner, IT, Validation, Quality, etc.), as well as those interested in the topics and seeking to remain current with industry trends and approaches.