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Webinar on FDA Quality Metrics and Risk Based Inspections

 
  March 04, 2016  
     
 


Compliance Trainings, Online
2016-03-08


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This live training webinar will discuss the just issued (July 2015) DRAFT Guidance for Industry on “Request for Quality Metrics” along with how FDASIA is pushing it forward, review the most common Citations issued during the past several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

 
 
Organized by: Compliance Trainings
Invited Speakers:

Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. Jane now operates as a Risk Management Trainer and Consultant, specializing in Study Level Risk Management and Risk Based Monitoring as well as facilitation of risk assessment workshops.

 
Deadline for Abstracts: 2016-03-08
 
Registration:

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1812

To register this webinar

https://compliancetrainings.com/siteengine/Login.aspx

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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