ICH Q10 Pharmaceutical Quality System 2014 is a webinar that covers topics such as:
- 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
ICH Q10 Pharmaceutical Quality System 2014 brings together:
- 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
