Webinar ID:   ISEM1312

2-Day Hybrid Seminar on cGMP for QC Labs

 
ON-DEMAND
  2 Days

Categories:   Uncategorised,

This is a Hybrid Workshop. The seminar will be physically conducted in BANGALORE 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:

  • Regulatory Requirements and Expectations
  • Design of a GMP Laboratory
  • Root Cause Investigation and CAPA
  • Analytical Method Validation
  • Equipment Qualification
  • DQ, IQ, OQ, PQ
  • System Suitability Testing
  • Calibration and maintenance of QC lab equipment
  • OOS, OOT and OOC Test Results
  • Laboratory Data Integrity
  • Audits and FDA Inspections
  • Group Discussions
  • Case Studies
  • Certification

ISEM1312

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.