PS 9000-2011 in the Pharmaceutical Supply Chain - Standards for Pharmaceutical Packaging Materials and Components: New Requirements and Implications 2012

Topics

• Industry Positions
  
  • Supplier prospective
  • Pharma expectations
  • Trades and bodies
  
  Fundamentals of the Standard::
  • Key requirements
  • ISO 9000 Relationship
  • Navigating the document
  • Applications of the standard u Understanding the Standard
  • Using annexes and Bibliography
  • Terms and Definitions
• Introduction to PS 9000
  
  • The journey and development process
  • Background overview
  • Future expectation
  • Role of PS in the supply chain
• Key Elements for a PS 9000 Quality Management System
• Preparing for Implementat
• Product Realisation
  
  • Specification & communication
  • Product supply evaluation
  • Product security
  • Change control
  • Interactive workshop
• Management and Quality Unit Roles
  
  • Interactive workshop u Resource Management
  • Requirements and guidance
  • Infrastructure & environmental conditions
  • Training
  • Interactive workshop
  • Guidance
• Key Areas for Measurement and Analysis
  
  • Interactive workshop
  • Requirements and guidance

Who should Attend

• Qualified Persons, QA Managers
• Suppliers of packaging materials and origination/artwork to the pharmaceutical industry
• Regulatory Compliance Managers
• QC Professionals/Executives
• Supplier/Contract Managers
• Production Managers
• Quality Auditors
• Supply Chain Managers