This course is designed for all levels of quality experience.
For the beginner, the course provides a logical and graphical perspective, enabling them to understand how the quality principles apply to their role and responsibilities. They will be able to apply these principles to their daily activities In preparation for advancement.
For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, improve internal auditing and make quality system improvements
This course brings the complex elements together into a congruent pattern that provides attendees insight to confidently apply these principles to their quality and regulatory environment. This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles.
This new paradigm forces industry leaders and the FDA to rethink their roles in this dynamic regulatory-business environment. Management must partner with Quality in order to establish, implement, and meet corporate objectives.
It challenges the FDA to focus on the importance of employing practical quality principles that emphasize the importance of designing for user and customer requirements. Management must have a quality process that assures these requirements are translated into a viable process through technology transfer, process validation and a monitoring system that provides data for analysis and evaluation.
This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles. Next, using a cross-index between the two documents, the key elements of these documents and their relationship will be studied.
Why should you attend :
This will provide considerable insight into how quality systems are constructed and operate to meet customer requirements. From these discussions, you will gain insight about how to actualize product and quality system improvements, as well to develop your own quality system.
Objectives & Overview
Good Manufacturing Practices And Quality Systems.
The Past, the Current, & the Future-The Changing
Defining Quality
Similarities between ICH Q 10 and Quality Systems Approach
Differences between ICH Q 10 and Quality Systems Approach
Quality Assurance and Production Responsibilities
Pharmaceutical Product Lifecycles.
Knowledge Management
Quality Improvement
Who will benefit:
Quality Control Laboratory Manager
Warehousing
Purchasing Managers and Procurement Managers
Laboratory Analyst
Cost Accounting
IT
Documentation Management
About Speaker
Howard T. Cooper enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA.
His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business
For the beginner, the course provides a logical and graphical perspective, enabling them to understand how the quality principles apply to their role and responsibilities. They will be able to apply these principles to their daily activities In preparation for advancement.
For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, improve internal auditing and make quality system improvements
This course brings the complex elements together into a congruent pattern that provides attendees insight to confidently apply these principles to their quality and regulatory environment. This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles.
This new paradigm forces industry leaders and the FDA to rethink their roles in this dynamic regulatory-business environment. Management must partner with Quality in order to establish, implement, and meet corporate objectives.
It challenges the FDA to focus on the importance of employing practical quality principles that emphasize the importance of designing for user and customer requirements. Management must have a quality process that assures these requirements are translated into a viable process through technology transfer, process validation and a monitoring system that provides data for analysis and evaluation.
This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles. Next, using a cross-index between the two documents, the key elements of these documents and their relationship will be studied.
Why should you attend :
This will provide considerable insight into how quality systems are constructed and operate to meet customer requirements. From these discussions, you will gain insight about how to actualize product and quality system improvements, as well to develop your own quality system.
Objectives & Overview
Good Manufacturing Practices And Quality Systems.
The Past, the Current, & the Future-The Changing
Defining Quality
Similarities between ICH Q 10 and Quality Systems Approach
Differences between ICH Q 10 and Quality Systems Approach
Quality Assurance and Production Responsibilities
Pharmaceutical Product Lifecycles.
Knowledge Management
Quality Improvement
Who will benefit:
Quality Control Laboratory Manager
Warehousing
Purchasing Managers and Procurement Managers
Laboratory Analyst
Cost Accounting
IT
Documentation Management
About Speaker
Howard T. Cooper enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA.
His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business
