U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Pharmaceutical Quality Resources
  5. Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems – Presentations (Days 1 & 2)
  1. Pharmaceutical Quality Resources

Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems – Presentations (Days 1 & 2)

    

Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems-Agendas

Introduction to PQS, Transforming Quality Culture, and the Business Case

Regulatory Perspectives on Quality Systems

Management Responsibility For Assuring An Effective Quality System

Management Responsibility For The Supply Chain (Contract Operations And Purchased Materials)

Lifecycle Goals of the PQS

Lifecycle Enablers: QRM and KM

Maintaining a State of Control throughout the Lifecycle

The Process Performance and Product Quality Monitoring System

ResourcesForYou