Quality Metrics and Risk Based Inspections: FDA'S New July 2015 Request for Quality Metrics Guidance for Industry & Safety and Innovation Act (FDASIA)

Angela K. Dunston

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This live training webinar will discuss the just issued (July 2015) DRAFT Guidance for Industry on Request for Quality Metrics along with how FDASIA is pushing it forward, review the most common Citations issued during the past several years, dissect each resultant Observation, explain the rationale behind them and present actual examples of Form FDA 483s and Warning Letters that include that particular Observation. A total of approximately 15 sections within CDERs CFRs from each year will be examined in detail and their frequency compared against previous years. This webinar is especially valuable to not only those within the Quality area of your Company, but also within other Departments to include Incoming Raw Materials, Manufacturing and Facilities. Because of the sensitivity and importance of understanding Quality Metrics, this live training webinar is a MUST for anyone in your organization that is involved in the management of, or recipients of Regulatory actions.

Course Objective

  • Learn about the new proposed Request for Quality Metrics and its Relationship to FDASIA 
  • Understand the Requirements of the FDAs Request to Industry 
  • Determine how the Draft Relates to Most Frequent Citations from 21 CFR 210/211
  • Learn of the Most Frequent Citations from within the 21 CFR 210/211 (Code of Federal Regulations (CFR) 
  • Review of the Past Several Years Overall Major Citations and how They may Impact your Organization
  • Hear the Rationale Behind an Observation and why the Underlying Citation was Cited
  • Comparison of Citations against Observations within Warning Letters
  • Interpretation of the Results
  • Review of Pertinent Form FDA 483s and Warning Letters

Course Outline

  • Introduction 
  • Human Drug Establishment Inclusion & Expectations
  • Quality Metrics Background
  • Process Validation and Quality Metrics
  • The Use of Quality Metrics
  • Effects of Non-Reporting
  • Reporting of Quality Metrics
  • Review of Pertinent Form FDA 483s and Warning Letters
  • Summary
  • Live Questions and Answers Session

Target Audience

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Manufacturing
  • Regulatory Affairs Professionals
  • Facilities
  • Those that use contract manufacturing and contract testing facilities
  • Contract Laboratories
  • API Manufacturers
  • Medical Device Companies

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Angela K. Dunston,

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization. During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients. The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the companys staff to ensure a cohesive transition for non-compliance to policy approval.

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