In July of 2015 the FDA issued a draft of a guidance, “Request for Quality Metrics” in which the Agency shared its plan to require all firms that market a drug substance or drug product to provide specific data to the FDA which it will use to calculate defined quality metrics. The Food, Drug and Cosmetic Act of 1938 along with the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2014, give the FDA the authority to require the reporting of Quality Metrics. This program will allow the FDA to monitor several key metrics throughout the pharmaceutical industry without inspecting a facility. They will give FDA valuable insights into effectiveness of the Quality Control Laboratory, the quality culture of the organization, and the level of management involvement and contribute to the risk analysis that will be used by the FDA to determine frequency of site visits. To date, senior management has not been as involved with the day to day product production operations as is expected in a contemporary quality system model. The quality metrics will make the involvement of management in product realization operations and the Quality System more visible to the FDA. It will impact the culture of all pharmaceutical firms.
The Quality Metrics program is consistent with ICH Q10, The Pharmaceutical Quality System, and FDAs campaign to drive: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”
This webinar by expert speaker John G. (Jerry) Lanese will provide information to management personnel at all levels of a pharmaceutical organization. It will identify the quality metrics that will be required and discuss the impact the metrics will have on the pharmaceutical firm. Also, a copy of the FDA Quality Metrics guidance will be provided to the participants.
Why Should You Attend:
This training will provides you an overview of the guidance along with details on quality metrics. Jerry will also provide advice on how your company can use this information to improve your compliance position with the FDA.
You will also get answers to the following tough questions:
Who Should Attend
- Dr. David Lim
Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...
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