2019 ISPE India Pharmaceutical Manufacturing Conference

The Quality Advantage: From Submissions to Approval to Sustainable Global Supply

The 2019 ISPE India Pharmaceutical Manufacturing Conference will focus on the product lifecycle approach from drug development to post-market approvals.  Topics will include critical approaches for successful manufacturing and leveraging quality as a competitive advantage. Speakers will include pharmaceutical and biopharmaceutical industry professionals along with regulators from FDA, MHRA, and APAC regions who are subject matter experts in quality and compliance. 


Conference Topics 

  • Quality as a Competitive Advantage
  • Risk Management Strategies in Manufacturing
  • Quality and Compliance: Addressing Risk Mitigation
  • Managing Root Cause Investigations
  • Submission Do's and Don'ts
  • Data Integrity in the Drug Submission Process
  • Understanding Quality: Where Does GMP Begin?
  • Chemistry, Manufacturing, and Controls (CMC)
  • Innovative Technologies for Quality Management Systems
  • Insights into Quality Culture in Biologics Manufacturing
  • Cell and Gene Therapy
  • Continuous Improvement
  • Cleaning Validation
  • Process Validation and Controls
  • Aseptic Processing

Who Should Attend?

  • Regulatory Affairs experts
  • GMP Inspectors
  • CMC professionals
  • Manufacturing and Operations professionals
  • Quality Assurance professionals
  • Quality Control professionals
  • Pharma Senior Level Managers 
  • Executive Level Leaders in Pharmaceutical and Bio Manufacturing

Learning Objectives

  • Become current on industry trends in quality & quality risk management
  • Understand quality and regulatory requirements and expectations
  • Address the recent developments and innovations in manufacturing
  • Understand the necessary elements for on-going quality sustainability

Program Committee

Chair
Joseph C. Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, Inc.
Placeholder Person Graphic
Myriam Sosa
Executive Director, QA GMP Compliance
Merck & Co., Inc.

Board Ambassador