Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs.
You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMPs with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach.
This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged.
Areas Covered in the Session: - Module 1 - Introduction to Quality and Compliance Concepts
- Module 2 - Differences between Medical Devices and Pharmaceuticals
- Module 3 - Scope of the GMPs and the Quality Cycle
- Module 4 - Standards of Quality
- Module 5 - The Shifting Paradigm to Focus on Customer and User Satisfaction- The Quality Systems Approach
- Module 6 - A Comparison of Definitions and Terms
- Module 7 - Comparison of Personnel and Management Expectations
- Module 8 - Comparing Design Requirements
- Module 9 - Comparing Master Records
- Module 10 - Comparing Equipment Controls
- Module 11 - Comparing Material and Incoming Controls
- Module 12 - Comparing the Control of Processes
- Module 12 - Packaging and Labeling Comparisons
- Module 13 - Laboratory Controls and Device Evaluation
- Module 14 - Holding, Distribution, & Returns
- Module 15 - Problem Solving-Deviations, Complaints, and CAPA
- Module 16 - How about Part 11
- Module 18 - Current Trends
- Module 17 - Review and Wrap-up
Who Will Benefit: - Quality, quality control, regulatory affairs, operations working in the FDA regulated medical products industry (Pharma & Device) in the design, scale-up, regulatory approval, commercialization, and maintenance of quality systems.
- Suppliers providing materials and contractors supplying outsourcing s services to FDA regulated clients.
- Companies working with Combination Products and him
