FDA Quality Metrics Guidance

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Get Much Needed Guidance on the FDA’s Quality Metrics for Your Organization


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.

Session Highlights:

  • Background for the Quality Metrics Program
  • The data that will be required by the FDA
  • The four Quality Metrics the FDA will calculate
    • Lot acceptance rate
    • Product Quality Complaint rate
    • Invalidated Out-of-Specification (OOS) rate
    • Annual, Product Review on-time rate
  • The three proposed additional Quality Metrics
    • CAPA Effectiveness
    • Percentage of CAPAs that require retraining as a corrective action
    • Process Capability/Performance

You will also get answers to the following tough questions:

  • When will the FDA implement the Quality Metric program?
  • What is the definition of senior management?
  • Are there other metrics that might be considered?
  • If my firm produces one product in three different facilities, who prepares the quality metrics report?

Learning Objective:

  • Discuss the FDA focus on regulations based on science or risk
  • ICH Q10, The Pharmaceutical Quality System
  • The background to quality metrics
  • The Quality Metrics Guidance including the new “Technical Conformance Guidance”
  • Data that will be required from the industry
  • The meaning of each of quality metrics.
  • How the firm can proactively apply the concept of quality metrics and the specific metrics that will be calculated by the FDA to support the concept of continual improvement
  • Challenges in meeting the FDA requirement for quality metrics

Who Should Attend

  • Senior management – site managers and above
  • Quality Assurance – at all levels
  • Quality Control – at all levels

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

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...   More Info
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