Best Practices for Quality Risk Management for the Pharmaceutical Industry 2015

Key Topics

• Manufacturing, Labeling and Packaging, Laboratory Testing and Quality Control
  • Practical Aspects (Value) of Risk Management
  • Doing RM Right Without Wasting Resources
  • Implementing RM in an Efficient and Effective Manner
  • Relationship with Other Quality Subsystems
  • Speaker`s Practical PASS-IT Guide
• Applicable Laws and Regulations
  • Risk Management (RM) Process - Systematic and Integrated
  • Key Definitions
  • Risk Management Tools and Methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
  • RM Principles
  • How to Facilitate Quality Risk Management
  • Risk Ranking
  • Risk Control Measures
  • Common Mistakes and How to Prevent Common Pitfalls
  • RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment
  • Risk Communication - How

Who should Attend

• Quality Professionals
• Regulatory Affairs
• Complaint And Risk Management Personnel
• R&D Professionals
• Contractors/Subcontractors
• Consultants
• VP’s
• CEO’s
• Attorneys
• Compliance Officers
• Other Interested Parties
• Clinical Affairs Personnel