Webinar ID:   ICT103

3-Hour Virtual Bootcamp on API Quality Systems

  3 Hours

Categories:   Quality,

Among GMP other aspects, API manufacturing Quality systems, environmental controls, and safety, are necessary to be taken into account in order to be in compliance with regulations. Business efficiency and continuous improvement are needed to be competitive. Therefore, GMP compliance should be incorporated into an overall Quality Management Systems (QMS) as it is recommended in the EU GMP philosophy and ICH Q10 ensuring benefit to the patient.

Whether electronic or manual systems and records are used for all GMP Quality system requirements of ICH Q7, data integrity needs to be maintained. The importance of an effective QMS on customer relations, continuous improvement, regulatory compliance, inspection readiness and supports ensuring supply of drug products to the market.

Seminar Agenda:

Each trainee Will benefit from The practical knowledge of Handling of API Quality Systems Elements and Updates w.r.t USFDA; EIdralex Volume -part II; WHO and PIC(s) like: –

  • Introduction
  • Quality Management
  • Personnel Requirement
  • Buildings and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification Labelling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control and its Updates
  • Rejection and Reuse of Materials
  • Complaints and Recalls
  • Contract Manufacturers and Contract laboratories
  • Agents, Brokers, Traders, Distributors, Re-packers, and Re-labelers
  • Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
  • APIs for Use in Clinical Trials
  • Question and answer section
Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Documentation Departments
  • Supply Chain Departments
  • All API and Formulation Companies


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.