ICH Q 10 Product Lifecycle

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This 90 minute webinar will give you the necessary guidance on the ICH Q 10 Product Lifecycle – From Concept to Ensuring User/Patient Satisfaction.

The Product Lifecycle concept is certainly not new and has been practiced and observed for decades if not centuries. It is particularly apparent in the manufacture and marketing of consumer products. We make purchasing quite frequently because a particular product has completed its cycle and we desire, want, or need improved product. Pharmaceutical products also have a repetitive lifecycle that has its own peculiarities. Although we were all aware of the product lifecycle, it is only lately that regulations and guidances began to clearly define expectations requirements of each phase of manufacturing and marketing.

This webinar will help you understand the complex environment of drug development, manufacturing, and marketing. You will gain a perspective on functional relationships that must work together throughout the product lifecycle. You will gain knowledge of how to assist management in understanding quality and regulatory roles so they may better direct and participate in these activities, and while leading multi-functional teams executing the product lifecycle.

Areas to be Covered:

A Primer on Pharmaceutical Product Lifecycle
Objectives & Overview
ICH Q8, Q9, Q10 & QSA
What is Product Lifecycle ?
Juran’s Quality Loop concept its relationship to the quality system
Medical Device and Pharmaceutical lifecycles
ICH Q10 Pharmaceutical Product Lifecycle
Building & construction phases, Pharmaceutical development & technology transfer and operation
Maintenance and improvement of end-product stages
Reviewing, Analyzing, & Understanding ICH Q10’s Pharmaceutical Product Lifecycle
ICH Q10 – 1.2 – Using the Product Lifecycle
Scope Of ICH 10 and Each Lifecycle Phase
ICH Q10 – 3.1 Product Lifecycle Stage Goals
ICH Q10 – 3.2 Product Lifecycle-Pharmaceutical Quality System elements
Examples of references to the product lifecycle throughout ICH Q10
Examples of references to the product lifecycle throughout ICH Q7A-Q9
The Product Lifecycle and Its Impact on the Quality Organization
Q&A Session

Who will Benefit:

QA / QC Managers and personnel
Regulatory Affairs
Product Management
Supervisors & Group Leaders
Production Management
Companies new to the FDA regulated industry
Compliance Management
Quality Unit Vice Presidents & Directors
Vice presidents, Directors and Managers of Operations

Howard T Cooper

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