Course Overview

This is the first module of the ‘Advanced Program in Pharmaceutical Quality Management’ (APPQM). This program has been designed by NSF, in collaboration with the Indian Drug Manufacturers' Association (IDMA), specifically for Indian Pharma companies. The APPQM provides participants with the skills to transform their quality culture and improve the effectiveness of their quality systems. Participants who pass the rigorous assessments will be awarded an internationally recognised APPQM Certificate from the IDMA and NSF International on completion.

Key Topics Covered In This Module

  • How to ensure your QMS is regulatory compliant, improves your competitive edge and drives business improvements
  • Integration of quality systems across the product lifecycle (quality systems approach for cGMP implementation, from philosophy to practice)
  • Making use of risk information to drive improvements (risk-based decision making)
  • Senior management roles and responsibilities for the QMS -- who must do what
  • The essentials of data integrity
  • The art and science of simplification
  • Batch release system: How to achieve 100 percent ‘right first time’
  • How to become stronger and better following complaints and recalls
  • Product quality reviews: How to use data and knowledge to drive improvement
  • Management review of quality systems and the use of quality metrics (measuring only what matters)
  • Continuous quality improvement and the cost of poor quality

Course Tutors

  • Martin Lush, MSc, FIBMS, PG Dip, EU Qualified Person. Global Vice President, NSF Pharma Biotech and Medical Devices
  • Robert Hughes, PGDQA, CChem MRSC, MCQI CQP. Consultant, NSF Pharma Biotech

To Register

To book a place on this course or for more information on this program contact Mr. Melvin Rodrigues, Sr. Manager (Commercial & Administration, IDMA, Mumbai), email: actadm@idmaindia.com.

You can also find more information in our brochure.

Register