Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance

This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.

A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering ERES. Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met.
Interactive exercises will be dispersed into and between the presentations.

LEARNING OBJECTIVES
Role of FDA
CSV Points
Why Validation? Its Benefits
GAMP 5
21 CFR Part 11 Compliance
Annex 11
Data Integrity
Risk Assessment
Recent Learnings & Avoiding Warning Letters
CSV Deliverables
SOPs and Best Practices
CASE STUDIES ….and More

WHO MUST ATTEND

DEPARTMENTS:
- Quality Control & Quality Assurance
- Research and Development
- Laboratory
- Regulatory Compliance
- IT/IS & Software Departments
- Validation
- Production & Manufacturing
- Documentation
- Training Departments

PROFESSIONALS:
- Managers and Supervisors
- Senior Managers and Team Leaders
- Directors, VP’s, CxO’s, General Managers
- Analytical Chemists
- Validation Specialists
- Laboratory Managers and Supervisors
- Regulatory Affairs Managers
- Documentation Specialists & Analysts
- Consultants and Systems Administrators