This webinar uses many graphical aids to enhance training. In addition, an indexed handout in electronic format will be included providing additional reference materials that may be explored by those interested in learning more.
Although the FDA and other regulatory authorities have written separate regulations and guidances for devices and pharmaceuticals, all GMP’s are based on the same quality principles. This can be readily seen by reviewing and comparing the table of contents for each cGMP regulations or guidance. These regulations/guidances have common elements such as management control, personnel, facilities and equipment, material controls, process control, laboratory, packaging labeling, distribution, recordkeeping, complaints, investigations and other common elements. These elements are frequently listed in the same order or some may be combined. However, they are either given in the regulation or are part of “industry practice”.
By studying and analyzing and comparing similarities and differences between several GMP quality systems, you will gain insight into how these systems operate to achieve customer satisfaction. This is particularly pertinent if your firm designs, manufactures, and markets combination products or several products that have separate GMP requirements. This webinar will provide ways that these systems may be harmonized between products into a single and combined GMP system. This will improve compliance and make the quality system more robust and effective.
This webinar begins by exploring the basic quality concepts and principles of the work of Juran, Deming, Crosby, and other “quality gurus”. Then the nature, definitions, and characteristics of devices, biologicals, pharmaceuticals, and combination products will be presented this to be followed by analyzing the contents of this CH Q7A, Part 210-211, Part 820, Part 600,and Part 1270-1271 to show similarities and differences. Reference will be made ISO 13485, and EU regulations as well as to ICH and GHTF guidances. Quality elements will be compared across all regulations.
Areas Covered in the Session :
Introduction to Quality and Compliance Concepts
Differences between Medical Devices and Pharmaceuticals
Scope of the GMPs and the Quality Cycle
Standards of Quality
The Shifting Paradigm to Focus on Customer and User Satisfaction- The Quality Systems Approach
Comparison of Personnel and Management Expectations
Comparison of Documentation Requirements
Comparing Design Requirements
Comparing Master Records
Comparing Equipment Controls
Comparing Material and Incoming Controls
Comparing the Control of Processes
Packaging and Labeling Comparisons
Laboratory Controls and Device Evaluation
Holding, Distribution, & Returns
Problem Solving-Deviations, Complaints, and CAPA
How about Part 11
Review and Wrap-up
Who Will Benefit:
Middle and Senior Management
Companies new to the FDA regulated industry
Senior quality management
Research & Development
Sales and Marketing, Finance & Cost Accounting, and Procurement Departments
Human Resources who have an active or supporting role in Quality
Other quality personnel who have the desire and/or potential to advance to quality leadership