Complianz World is a US based company, and a leading GRC training provider has announced to conduct Online Training & Webinar on Laboratory investigation out of-specification results

1. www.complianzworld.com

2. Course Description:
 In this 90-minute training on laboratory Out-of-
specification (OOS) investigations, you will learn what
constitutes an OOS observation, what is the OOS
investigation process described in the OOS guidance
and steps to be taken in the laboratory in the event of
an OOS observation.

3. Course Objective:
 Inadequate procedures for laboratory Out-of-
specification (OOS) investigations remain high on the
list of FDA observations. The FDA has issued a
guidance on the topic
 OOS procedures and investigations are still a topic of
FDA Investigator review and findings. An out-of-
specification laboratory observation triggers
emotional and political actions that inhibit a
productive investigation with a timely conclusion.

4. Course Objective:
 There is still confusion in the laboratories as to how an
out-of-specification result should be handled and
investigated.
 In this webinar we will discuss the investigation that
goes on within the laboratory. Although the focus will
be on the FDA Guidance, the discussion will include
suggestions for a process that will meet the FDA
expectations.

5. Course Outline:
 Regulations and Guidance that will be covered.
 US.
 21CFR211.160
 FDA Guidance to the Industry: Investigating Out-of-
Specification (OOS) Test Results for Pharmaceutical
Production

6. Target Audience:
 Quality Control Managers
 Quality Control Supervisors
 Quality Control Analysts
 Quality Control Record Reviewers
 Quality Assurance Managers
 Quality Assurance Supervisors
 Quality Assurance Record Reviewers

7. Thank You
Complianz World is a US based company, and a leading
GRC training provider has announced to conduct
Webinar or Online Training on
Laboratory Investigation Out-of-Specification Results