Webinar ID:   ISEM3010

1-Day Hybrid Seminar on Computer System Validation Masterclass

  1 Day

Categories:   Uncategorised,

This is a Hybrid Workshop. The seminar will be physically conducted in Hyderabad and simultaneously Live Streamed to delegates attending Virtually. If you have a bigger group, please contact us at 080-4170-0521 or info@ComplianceTrainings.in

Seminar Agenda:
– GAMP 5
– Annex 11
– Warning Letters
– Validation Process
– Vendor Management
– Computer Software Assurance
– Data Integrity
– Group Discussions
– Case Studies
– Certification

Seminar Page

G Sundar

G. Sundar is a quality practitioner with vast experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines.

He has conducted more than 50 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations,), 10 Contract Research and Analytical laboratories, 4 Clinical research CROs. He has also conducted 100 plus trainings all over India, Asia and Europe.

Mr. Sundar Ganesan is currently working as Director-Consultant at PharmQA Compliance services an independent consultant.