Date: 15th - 16th September, 2008

Location: Toronto, Canada

Summary:
Pharmaceutical - Training, Seminar

Interpreting and Applying ICH Q10 Pharmaceutical Quality Systems Guidance

A Two Day Comprehensive & Interactive Course, with Workshops and Case Studies On:

• Interpreting and Applying ICH Q10 Pharmaceutical Quality Systems Guidance
  
• Comparing cGMP Requirements versus ICH Q10 Guidance
  
• Essential elements to successfully transition from cGMP to a Quality System
  
• Designing and Implementing a Pharmaceutical Quality System
  
• Managing the Quality System and Supporting Processes
  
• Using Quality Risk Assessment and Risk Management
  
• Applying a Systems Approach for Assessment and Measurement
  
• Conducting a Gap Analysis of Quality Systems
  
• Developing Effective Quality Policy and Quality Planning
  
• Making Decisions Based on Understanding the Intended Use of a Product
  
• Tools and Techniques to Review Current Quality Activities
  
• Systems for Careful Analysis of Product Quality
  
• Identifying and Controlling Areas or Weakness in the System or Process
  
• Deviation and Investigation Management for Effective and Timely Remediation
  
• Maintaining a Well Defined Process and Product throughout the Product Life Cycle
  

Interactive Workshop & Group Exercises:

• Comparing cGMP Requirements versus ICH Q10 Guidance
  
• Contrasting "Old Approach" cGMP versus "New Approach" Quality Systems
  
• Identifying clear definition of roles, responsibilities, authority and accountability for establishing an effective, efficient and compliant Pharmaceutical Quality System
  
• Interpreting and applying systems-based approaches to manufacturing and distribution of finished pharmaceutical products.
  
• Analyzing recent Pharmaceutical Quality System assessment findings and observations, including FDA Inspection and Enforcement Trends