Training is essential aspect for Pharmaceutical and Health Care sector ensuring regulatory compliance, particularly in industries governed by standards like those from the FDA or EMA.
It helps maintain high quality assurance by ensuring systems perform reliably and produce accurate results.
Our experts deliver on-site/ On-line knowledge-sharing session on various GxP topics to all such as:
GAMP 5
21 CFR Part 11
Computerized System Validation (Basic and Advanced)
GDP/GMP
Quality Management Systems Processes
Computer Software Assurance (CSA) Principles
Statistical Intervals for Validation
Data Integrity
Cloud and SaaS in GxP
Spreadsheet Validation
Risk Based Approach for Validation
Software Quality Audit (Third Party/Regulatory)