Webinar ID:   ISEM2409

1-Day Hybrid Seminar on Cleaning Validation Modern Techniques, Application And Controls

 
ON-DEMAND
  6 Hours

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:
– Regulatory background and benefits of QbD
– Quality Risk Management (QRM) (process and tools e.g. FMEA, risk ranking)
– Designing the Control Strategies
– PQS & GMP and their link to Control Strategies
– Design of Experiments
– Developing a Design Space
– Process Analytical Technology (PAT)
– The importance of technology transfer
– The use of a technical review and Product Strategy Review systems
– Tools and Templates used for technology transfer
– Analytical Testing, Validation, Transfer
ISEM2808

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.