Quality Metrics Program: FDA Challenges and Requirements including the New 'Quality Metrics Technical Conformation Guide' Released June 2016

Duration: 90 Minutes
The Food, Drug and Cosmetic Act of 1938 as revised by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2014, gives the FDA the authority to require the reporting of Quality Metrics. In July 2015 the FDA issued a draft guidance, 'Request for Quality Metrics' in which the Agency shared its plan to require all firms that market a drug substance or drug product in the U.S. to provide specific data to the FDA which it will use to calculate defined quality metrics. This was recently followed, in June 2016, by an addendum, 'Quality Metrics Technical Conformance Guide' which clarifies the format of the metrics that must be submitted.
New Quality Metrics Technical Conformation Guide
Instructor: John G. Lanese
Product ID: 501727
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, in most firms, 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."

Objectives of the Presentation
The objective of this webinar is to inform and educate the pharmaceutical industry community of the expectation of the FDA that all firms that produce a finished drug form or an API that is used in a finished drug form submit data that the FDA can use to calculate firm-specific quality metrics. This Quality Metrics program is justified by amendments to the Food, Drug and Cosmetic Act enacted in the FDASIA and will allow the FDA to monitor the activities without an on-site inspection an schedule risk based on-site inspections, based in-part on the Quality Metrics. This program is consistent with the FDA emphasis of the Pharmaceutical Quality System identified in ICH Q10.

Why Should you Attend
It is important that all elements of the firm understand what the FDA is doing, why it has initiated the new Quality Metrics Program, the impact of the program and how the firm can prepare for the implementation of the program.

Areas Covered
  • FDA interest in Quality Metrics
  • What are Quality Metrics
  • Quality metrics parameters FDA will request
  • Data that is required by the industry
  • The meaning of each of the quality metrics
  • The reporting format for the Quality Metrics
  • The impact of the FDA expectations on the pharmaceutical firm
  • Suggestions on how the firm can use the metrics to proactively support continuous improvement
  • An outsider's prospective
  • What is ahead
Who will Benefit
The following individuals or disciplines should attend
  • Quality Assurance - all levels
  • Quality Control - all levels
  • Operations - site management
  • Senior corporate management
  • Auditors - all levels
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Instructor Profile:
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 he has managed Analytical Research, Quality Control and Quality Assurance functions.

In 1994 Dr. Lanese formed his own company, The Lanese Group, since then he has been a consultant in the area of quality system and cGMP compliance and has been consulted by small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.

Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. 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 the best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.


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