FDA Requirements for Quality Metrics, Guidance for Industry & The New "Quality Metrics Technical Conformance Guide" Released in June 2016

Live, Interactive Training Webinar

Date: Available Live On-Demand
Instructr: Jerry Lanese Ph.D. Biography>>>

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At the turn of the century, the FDA announced an initiative, “Pharmaceutical Good Manufacturing Practices for the 21st Century” to enhance and modernize the regulation of pharmaceutical manufacturing and improve product quality. Since that time the Agency has issued a number of guidance documents that support the contemporary Quality System approach and expands the initiative. The center point of these guidances is ICH Q10, The Pharmaceutical Quality System. Three of the elements of a Quality System identified in this guidance ae Management Review, Process Performance and Product Quality Monitoring, and CAPA.

In 2012, Congress passed the FDASIA (Food and Drug Administration Safety and Innovation Act) that allows the Agency to change the way regulates and monitors the compliance of the pharmaceutical firms. As a follow-up to this Act, the FDA, in July 2015 published a guidance, “Quality Metrics”, that supports the Pharmaceutical Quality System, specifically the three elements cited above. In June 2016, the FDA released a technical reference document, “Quality Metrics Technical Conformance Guide”. supplementing the draft guidance, the new document clarified how the FDA expect e information on quality metrics to be collected and reported. Then, in November 2016, the Agency issued the third related guidance, “Submission of Quality Metrics Data”. In this guidance, the FDA identified their plan to limit their expectations to three metrics and the submission will be voluntary. The metrics will allow the Agency to monitor lot acceptance rate, product complaint rate and invalidated OOS rate. These metrics will allow the FDA to evaluate the quality culture of the firm. The Agency expectations relating to quality metrics may change again.

The expectation that firms use metrics to monitor their operations will significantly impact every firm producing and/or marketing active ingredients and pharmaceutical products produced sold in the US.

This webinar discusses the background to the release of the guidances related to Quality Metrics. This includes:
- Quality Metrics
-The evolution of quality metrics and quality systems
-Each of the metrics identified in the guidances
-Industry responses
-Data FDA will expect
-Calculation of the metrics
-Interpretation of the metrics
- Suggestions on how the firm can use the metrics proactively
- Impact of the metric on the pharmaceutical firm

This live training webinar is for management at all levels of a pharmaceutical firm, as well as Quality Assurance and Operations personnel. Since the FDA has implied that it will extend the expectation for quality metrics to all of its regulated industries, this training is of interest to management and quality personnel in all FDA regulated industries.

Learning Benefits
-Discuss the FDA focus on regulations based on science and risk.
-ICH Q10, The Pharmaceutical Quality System.
-The family of FDA and ICH guidances that support ICH Q10.
-The background to quality metrics.
-The three Quality Metrics guidances
-Data that will be required from the industry.
-The meaning of each of the quality metrics.
-How the firm can proactively apply the concepts of quality metrics and the specific quality metrics that will be calculated by the FDA to support the concept of continuous improvement.
-Challenges in meeting the FDA requirements for quality metrics.

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM GMPs in the 21st Century, Science Risk,
ICH Q9 The Pharmaceutical Quality System
ICH Q10, FDASIA, Process validation,
The Quality Metrics Guidance – an overview,
Quality Metrics – nothing new,
The date that will be requested,
The metrics: Discussion of each metric, Evaluation of the metric, Impact of the metric on the organization, Proactive application of the metric,
10:30 AM Break
10:40 AM The metrics (continued),
The challenges,
Summary,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A copy of Guidance for the Industry Quality Metrics
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Senior corporate management
  • Operations - site management
  • Quality management- all levels
  • Quality Assurance - all levels
  • Auditors - all levels

Schedule & Deliver this Live Training Webinar Privately to Your Group


Instructor: John G. (Jerry) Lanese Ph.D.

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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry… Full Bio>>>

 

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