Proactive Internal Auditing-The Key to Establishing, Maintaining, and Improving Quality Systems

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This webinar provides a broad overview of the internal auditing functions starting with the concept of quality systems and their objectives, primarily using graphical methods. The webinar focuses on the role of the internal audit function throughout the product lifecycle. It focuses on the importance of using knowledge to prevent failure and to improve the quality system.

The internal audit is part of a monitoring system that provides Senior Management with the knowledge to act as needed to maintain and improve the associated quality processes. While the internal audit is inherent in the device regulations, the internal audit in the pharmaceutical environment has been less structured but has become more formalized structured in the FDA 2006 guidance, The Quality Systems Approach To the Pharmaceutical Good Manufacturing Practices. In 2008, ICH published, ICH Q10, Pharmaceutical Quality Systems, that describes the role of audits in maintaining and improving the quality system. The FDA adopted ICH Q10 in 2012.

The FDA regulated industry at all levels fear FDA inspections. The most likely reason for this fear is that deficiencies will be found that require significant actions and time to correct. A proactive internal auditing system providing ongoing communications to management combined with appropriate management action can relieve these fears and provide greater confidence.

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 to be Covered:

Defining and describing the modern quality system and its life-cycle
What are the objectives of internal auditing?
Defining the audit process and its cycle
Organizing the quality audit functions
Can a job description be written for an internal auditor?
Auditing Responsibilities
in the internal audit is not the same as FDA inspection
Auditing may be both subjective and objective
The inter-functional audit team
Going way beyond the audit checklist
Categorizing findings-CAPA, remediation, or improvement
The audit report life-cycle
Internal Auditing trends
FDA enforcement of internal audit requirements

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.

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  • Presentation Handout in .pdf format
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