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 mid1980s. 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

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