Validating Manufacturing Control Systems (MCS) to Meet Compliance Requirements


This webinar will cover the unique validation requirements and compliance issues of the most critical system in your supply chain viz. the manufacturing control system.

Visitors

Healthcare providers,Regulatory, QA/QC personnel,Engineering, Manufacturing and Manufacturing Science.

Exhibitors

Chinmoy Roy, is an independent consultant. His specialties include CSV, CFR 21 Part 11, QRM, Internal and External audits, and QA of computer systems in large scale manufacturing, clinical trials and laboratories. His team pioneered the successful implementation of a CFR 21 Part 11 compliant system. This paperless bulk manufacturing control system integrates SAP, MES, LIMS, Weigh and Dispense and DCS. This highly complex system was a precursor to FDA’s Part 11 Scope and Application Guidance document in 2003. He also has a broad experience in facilitating QRM sessions and establishing Quality Risk Management plans for his clients.

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