ICH Q10 Pharmaceutical Quality System

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Description :

ICH Q10 is particularly important because the USA, Canada, Europe, and Japan have announced their intentions to adopt the ICH Q10 guidance. Therefore, it is necessary to understand and comply with this guidance in order to market your products across international boundaries. However, there is another and probably more important reason. The reason being that this guidance has some very useful quality concepts that have the potential to help maintain and improve your quality system for improving compliance and increasing customer satisfaction. For greater insight about maintaining and improving quality systems, review the FDA’s “Quality Systems Approach to the Pharmaceutical GMPs”

This webinar provides a broad overview of ICH Q10, The Pharmaceutical Quality System. ICH Q10 is applicable throughout the pharmaceutical lifecycle. Unlike the FDA Quality Systems Approach limited applicability, ICH Q10 explains the application of quality principles and concepts to the regulations. The ICH Q10 concepts will be presented in a logical sequence that will show their applicability to the pharmaceutical product lifecycle to strengthen the link between pharmaceutical development and manufacturing activities.

This webinar focusses on The Quality Systems Approach (QSA) To Pharmaceutical Good Manufacturing Practices. The focal point of the QSA is drug substances and products but its principles apply to all FDA regulated industry. This guidance is written in a non-regulatory format explaining GMP concepts in a practical and easily understood way. This webinar uses many graphical aids to increase interest and enhance training.

Middle and Senior Management from all functions involved in establishing and executing corporate strategy and objectives. It is particularly applicable to companies new to the FDA regulated industry.

Senior quality management will gain insight on how quality systems work and will be able to better understand senior management responsibilities. Provide knowledge that can be used to persuade others concerning quality matters.

Finance, Sales and Marketing, Operations, Procurement, and 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.

Areas Covered in the Session :
Course Introduction, Objectives, & Quality Philosophy
Defining the Role of Quality and Compliance in the Organization
Why does ICH Q10-10, Pharmaceutical Quality Systems, Exist? Introduction, Scope & Objectives
Arrangement & Organization of the ICHQ 10 Guidance
Relationship to other regulatory requirements & regional regulations
Enablers-Knowledge, Risk, & Design Management
Introduction to the Pharmaceutical Product Lifecycle
First Introduction to the Quality Manual
Management Responsibility
Pharmaceutical Quality System Elements
Continual Improvement of Process Performance & Product Quality
Continual Improvement of the Pharmaceutical Quality System
Regulatory Body Enforcement
Quick Review

Who Will Benefit:
Middle and Senior Management
Companies new to the FDA regulated industry
Quality Assurance
Quality Control
Regulatory Affairs
Senior quality management
Compliance Director
Vice Presidents
Project Leaders
Research & Development
Sales and Marketing, Finance & Cost Accounting, and Procurement Departments
Operations Department
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

Howard T Cooper, President, EQACT, Inc., Independent Consultant, 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 in 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.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance