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
Quality Assurance Managers
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.
Mr. Cooper built on this experience to set up a pharmaceutical /medical device and combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.