New Hyde Park, NY, September 03, 2015 --(PR.com
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.
An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMP trainings with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach.
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
• 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
• Quality Assurance Managers
For more information, please visit bit.ly/1PMgynD
About Compliance Global Inc:
Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.
Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.
Toll Free: +1-844-746-4244