This live training webinar will discuss the just issued (July 2015) DRAFT Guidance for Industry on “Request for Quality Metrics” along with how FDASIA is pushing it forward, review the most common Citations issued during the past several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.
Areas Covered in the Session :
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
Who Will Benefit:
Quality Assurance Teams
Quality Control Teams
Research & Development Teams
Regulatory Affairs Departments