A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences.

Overview:

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 webinar experience. Questions are strongly encouraged.

Why Should You Attend:

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.

Areas Covered in this Webinar:

• Module 1 - Introduction to Quality and Compliance Concepts
• Module 2 - Differences between Medical Devices Companies 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 – Product Packaging and Labeling Comparisons
• Module 13 - Laboratory Quality Control 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

Learning Objectives:

• Scope of the GMPs and the Quality Cycle
• The Shifting Paradigm to Focus on Customer and User Satisfaction - The Quality Systems Approach
• Comparing Design Requirements
• Comparing the Control of Processes
• Product Packaging and Labeling Comparisons
• Laboratory Quality Control and Device Evaluation

Who Will Benefit:

• Quality Control Professionals
• Regulatory Affairs Professionals
• Operations Departments
• Suppliers
• Quality Assurance Managers

Speaker Profile:

Howard Cooper has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader.

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