Quality Metrics and Risk Based Inspections: Quality Metrics Guidance for Industry & Safety and Innovation Act (FDASIA)
Duration : 60 Minutes
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 Read more
This live training webinar will discuss the just issued (July 2015) DRAFT Guidance for Industry on “Request for Quality Metrics” along with how FDASIA is pushing it forward, review the most common Citations issued during the past several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 CDER’s 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 Objectives:
• Learn about the new proposed “Request for Quality Metrics” and its Relationship to FDASIA
• Understand the Requirements of the FDA’s 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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