$155.00

GLP/cGMP for Testing Laboratories – By AtoZ Compliance.

  • URL: http://bit.ly/1SDy7uM
  • Date: March 31st Thursday
  • Listed: February 25, 2016 9:20 pm
  • Expires: This ad has expired
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Description

Speaker: Cinta Burgos

Key Take Away:

Get an introduction to GxP Study, the basic steps, intentions and goals of the US FDA Regulations and World standards, as well as how the industry uses GxP Analytical and Animal Testing.

Overview:

This webinar will cover the history and practical basics of GLP training and cGMP training (combined referred to as GxP) for analytical testing laboratories. The intent is to introduce the student to what a GLP Study is, the basic steps, intentions, and goals of the US FDA Regulation training and world standards, and how industry uses GxP Analytical and Animal Testing.

The goal is for each student to understand his or her potential role(s) in a study and what might be expected of them in industry or in an academic setting.

For each lecture topic listed below, industry examples and sample FDA warning letters will be used.

• General Introduction and GxP compliance, history, study use, key terms and personnel
• The different uses of GLP and cGMP Testing
• Protocols and Reports
• Master Schedule
• Phase Inspections
• Method Validation
• Data and analysis integrity, review and archiving
• Out of Trend, Out Of Specifications
• Deviations, Corrective Actions, and Amendments
• FDA inspections and Sponsor audit preparation

Why Should You Attend:

Contract Research Organizations and Analytical Laboratories are becoming more scrutinized by regulatory authorities and methods and resulting data integrity more important. Get things right from the beginning of your study or testing by defining what needs to comply with GLP or cGMP regulations.

If you are responsible for a testing laboratory and are running both GLP and cGMP testing, use this training to help define what level of compliance is necessary or expected.

Areas Covered In This Webinar:

The history and practical basics of a Good Laboratory Practice (GLP) study and current Good Manufacturing Practice (cGMP) for analytical testing laboratories and to introduce the student to what a GxP Study is, the basic steps, intentions, and goals of the US FDA Regulations and world standards, as well as how industry uses GxP Analytical and Animal Testing.

Learning Objectives:

• Learning the practical basics of a Good Laboratory Practice (GLP) study and current Good Manufacturing Practice (cGMP) for analytical testing laboratories
• To introduce the student to what a GxP Study is, the basic steps, intentions, and goals of the US FDA Regulations and world standards, as well as how industry uses GxP Analytical and Animal Testing
• The goal is for each student to understand his or her potential role(s) in a study and what might be expected of them in industry or in an academic setting

Who Will Benefit:

• Quality Assurance Professionals
• Regulatory Professionals
• GLP/cGMP Analysts
• Animal Technicians
• Principle Investigators
• Laboratory Managers
• Auditors

Level:

Beginner

For more information, please visit http://bit.ly/1SDy7uM

Email: referrals@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Ad Reference ID: 23856cfeeb54f65b

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