Why Should You Attend:
By studying relationship between quality and quality system, we can better understand the role of the quality manual. Juran* defines quality as “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.” Then, he defines the quality system as “the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.”
The goal of the quality manual is to achieve product quality by formalizing the system for the design, manufacture, and marketing products satisfying multi-faceted needs and requirements.
For the health professional, it provides consistent and reliable product performance.
For the patient, it fulfills the need for restored health.
For the FDA, it provides documented evidence that processes are in control.
The quality manual is the core system, a set of, commonly owned procedures created through collaboration and multi-function approval, which ensure product quality and compliance.
By attending, this webinar you will learn
Areas Covered in the Webinar:
Part I-PowerPoint Presentation-Understanding and Describing the Quality Manual
Part II-Handouts-Flowcharts to Further Enhance Knowledge of the Quality Manual
Who Will Benefit:
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.
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.He has developed several quality manuals from scratch and has revamped quality manuals as part of warning letter and consent decree situations.
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