Conducting an Effective Lab Internal Audit - Steps to Assure Compliance

This laboratory assessment training will focus on the role and importance of internal audit to ensure

compliance with FDA regulatory requirements. Attendees will learn how to plan and execute laboratory

audits or assessments.

Why Should You Attend:

Quality control laboratories have been an important part of FDA inspections since the mid-

1980s. These laboratories are generally staffed by highly educated and trained personnel and

equipped with sophisticated instrumentation. In order to meet regulatory requirements and have

appropriate internal controls, laboratories must implement extensive laboratory control systems

which are defined in extensive procedures. The organization and the laboratory must have

proactive programs that provide assurance that the laboratory is continually in compliance with

regulations and internal procedures. The internal audit or assessment is one tool for assuring

continual compliance.

This webinar will discuss how internal audits can assure compliance in the laboratory.

Learning Objectives:

Upon completion of this webinar, attendees will understand:

The use of standards as the basis for assessments

Audits and assessments

How to plan a laboratory audit/assessment

How to execute laboratory audits/assessments

The audit report

The importance of the audit follow-up

Areas Covered in the Webinar:

Standards for the assessment of the laboratory

Audit Plan

Audit process – what to look for

Audit report

Audit follow-up

Who Will Benefit:

Development Laboratory Managers

Quality Control Laboratory Managers

Quality Assurance Managers

Quality Control Chemists

Quality Control Microbiologists

Internal Auditors

For more details visit us at:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703323?

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