About the Client
Hetero is one of India’s leading pharmaceutical companies with a strong global footprint in over 126 countries. Founded with a vision to make healthcare affordable and accessible, Hetero has grown into a vertically integrated organization spanning Active Pharmaceutical Ingredients (APIs), Finished Dosage Formulations (FDFs), biosimilars, and branded generics. The company is recognized for its excellence in R&D, manufacturing, and regulatory compliance, supported by more than 36 state-of-the-art manufacturing facilities approved by stringent regulatory bodies such as the USFDA, EU EMA, TGA, and WHO-GMP.
Workshop Objective
This workshop was designed to provide an in-depth understanding of Computerized Systems Validation (CSV) aligned with GAMP 5 principles, tailored to the regulatory and operational realities of the pharmaceutical environment. The session aimed to enhance compliance readiness, reduce validation risks, and improve cross-functional collaboration between QA, QC, IT, and engineering teams.
Workshop Summary
The session focused on equipping participants with practical tools and a clear understanding of GAMP-based validation approaches. Through expert-led modules and real-world case studies, the workshop demystified CSV documentation practices and demonstrated how to embed compliance into system lifecycles—whether for lab equipment, enterprise platforms like SAP, or local manufacturing systems.
Key highlights included:
- Principles of GAMP 5: Clear breakdown of system categorization, V-model, and lifecycle phases tailored to pharma environments.
- FDA, EUDRALEX, and PIC/S Alignment: CSV practices were contextualized for global compliance frameworks, including 21 CFR Part 11 and Annex 11.
- Risk-Based Validation Strategy: Emphasis on prioritizing efforts where compliance risk is highest—supporting audit-readiness and data integrity.
- End-to-End CSV Lifecycle: Hands-on walkthrough of validation planning, requirement specifications, IQ/OQ/PQ, test scripts, deviation management, and traceability matrix.
- Real-World Insights:
- Challenges and strategies from FDA Consent Decree remediation.
- Examples from Trackwise, Empower, SAP, LMS, and Lab Systems validations.
- Best practices for validating standalone systems and spreadsheets.
- Role Clarity and Collaboration: Reinforced the roles of QA, IT, Engineering, and Operations in ensuring validation compliance.
Workshop Details
- Mode: On-Site
- Audience: Engineering, QA, QC, CQA, AQA, and IT teams
- Batch Size: 20 Participants
- Duration: 1-day Workshop
- Customized Training Modules
- Certificates for all participants
Trainer (Speaker) Profile
- An Automotive R&D and Design Optimization Specialist with 33+ years of industry experience.
- Expert in electrical and electronics systems, VFD/servo/PLC applications, and embedded automotive controllers.
- Proven track record in reducing motor noise, optimizing hydraulic systems, and building test rigs for OEM applications.
- He has trained professionals across automotive and industrial domains in DFM/DFA, electronics, solar systems, and actuator-driven controls.
