| Greetings!
The healthcare industry continues to accelerate its adoption of computerized and automated systems across Pharma, Medical Devices, Biotech, and Healthcare Logistics. Ensuring these systems are validated, compliant, auditable, and inspection-ready has never been more essential.
To equip professionals with practical and regulatory-aligned understanding, we're hosting the Computer System Validation Workshop led by senior instructor Krishnachaitanya Pabbaraju.
Krishnachaitanya brings 10+ years of specialized, hands-on experience in validating mission-critical computer and quality systems in regulated environments. His work spans pharmaceutical, medical device, biotechnology, and healthcare logistics sectors, with deep operational grounding in GXP, GAMP 5, 21 CFR Part 11, Annex-11, and GxP-driven quality management frameworks.
His career includes leading Global IT Quality system creation and rollout, including enterprise IT policies, SOPs, and standard operating procedures, driving cross-regional compliance infrastructure that stands up to inspection scrutiny. His technical leadership has been applied on systems such as ERP, LIMS, LIMS-integrated lab platforms, Quality Management Systems, Document Management Systems, TrackWise, TrackWise-driven CAPA/Deviation modules, and Supply Chain Validation frameworks.
Krishnachaitanya has led validation life-cycle governance for VLMS, LMS, and supply-chain compliance rollouts, ensuring data integrity, risk control, and audit readiness throughout system use. His experience uniquely bridges validation, quality, compliance and operational leadership - a vantage shaped further through his role as a current leader driving digital innovation in healthcare logistics while strengthening quality and compliance outcomes through emerging technology adoption.
This workshop will not merely review CSV principles, but unfold the “how” behind regulatory conformity - system categorization, V-model application, test planning (IQ/OQ/PQ), Part 11 controls, deliverable creation, lifecycle maintenance and audit preparedness, supported with field-based insight rather than textbook abstraction. | 
No comments:
Post a Comment