ICH Q10 Pharmaceutical Quality System 2014

Topics

• Defining the Role of Quality and Compliance in the Organization
• Course Introduction, Objectives, & Quality Philosophy
• Arrangement & Organization of the ICHQ 10 Guidance
• Why does ICH Q10-10, Pharmaceutical Quality Systems, Exist? Introduction, Scope & Objectives
• Enablers-Knowledge, Risk, & Design Management
• Relationship to other regulatory requirements & regional regulations
• First Introduction to the Quality Manual
• Introduction to the Pharmaceutical Product Lifecycle
• Pharmaceutical Quality System Elements
• Management Responsibility
• Continual Improvement of the Pharmaceutical Quality System
• Continual Improvement of Process Performance & Product Quality
• Quick Review
• Regulatory Body Enforcement
• Q&A

Who should Attend

• Companies new to the FDA regulated industry
• Middle and Senior Management
• Quality Control
• Quality Assurance
• Senior quality management
• Regulatory Affairs
• Vice Presidents
• Compliance Director
• Project Leaders
• Consultants
• Sales and Marketing, Finance & Cost Accounting, and Procurement Departments
• Research & Development
• Human Resources who have an active or supporting role in Quality
• Operations Department
• Other quality personnel who have the desire and/or potential to advance to quality leadership