Webinar on FDA Quality Metrics and Risk Based Inspections

Description :

This live training webinar will discuss the just issued (July 2015) DRAFT Guidance for Industry on “Request for Quality Metrics” along with how FDASIA is pushing it forward, review the most common Citations issued during the past several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 :

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

Who Will Benefit:

Quality Assurance Teams

Quality Control Teams

Research & Development Teams

Manufacturing Teams

Regulatory Affairs Departments

Scientists

Pharmaceutical Manufacturers

Contract Laboratories

API Manufacturers

Device Manufacturers

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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