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
Who will Benefit:
QA / QC Managers and personnel
Supervisors & Group Leaders
Companies new to the FDA regulated industry
Quality Unit Vice Presidents & Directors
Vice presidents, Directors and Managers of Operations