Computerized System Validation

The course covers critical aspects of US FDA and EMEA regulations, 21 CFR Part 11 compliance, GAMP 5 guidelines, data integrity, and audit trails. Participants will gain hands-on knowledge of risk-based validation approaches, electronic signature compliance, backup and restoration procedures, and effective communication with regulatory authorities. Through interactive sessions, case studies, and real-world scenarios, this program equips learners with the skills needed to ensure compliance while maintaining operational efficiency.

Key Learning Objectives:

✔️ Understand US FDA and EMEA regulatory expectations for Computer System Validation (CSV)

✔️ Learn about 21 CFR Part 11 compliance for electronic signatures and audit trails ✔️ Gain insights into GAMP 5 classification and risk-based validation approaches

✔️ Master audit trails and their role in data integrity

✔️ Explore backup and restoration procedures for validated systems

✔️ Develop expertise in regulatory communication and handling audits effectively Who Should Attend?

✅ Professionals in Pharmacovigilance, Clinical Research, Regulatory Affairs, IT, and Quality Assurance

✅ Individuals involved in software validation, system compliance, and audit preparation

✅ Fresh graduates looking to enter the pharmaceutical and healthcare compliance domain