Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.

The objective of this live training webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The interactive live discussion will be based on the FDA guidance on handling OOS laboratory results and to provide a clear process for compliant laboratory OOS investigations.

This Live Webinar Will Cover:

• The requirements for laboratory OOS investigations.
• Latest Regulatory expectations.
• The laboratory OOS investigation process.
• Laboratory investigation, Phase I.
• Laboratory investigation, Phase II.
• Retesting.
• Resampling.
• Communicating with Quality Assurance.

Learning Benefits:

• Understand the developing expectation for appropriate OOS investigations.
• Understand of the expectation for the identification of the cause of the OOS results.
• Gain a clear insight of the laboratory OOS investigation process.
• Learn the terminology associated with laboratory OOS investigations.
• Learn about outlier testing.
• Understand how the OOS laboratory investigation process relates to the general expectation for deviation investigation.

Regulations and Guidances that will be covered;

• US - 21CFR211.160, 192
• ICH Q7; 11.1
• FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                The requirement for Laboratory OOS investigations,
The Laboratory investigation – Phase I,
The Laboratory investigation – Phase II,
Identification of the cause of the OOS,

11:30 AM 10 Minute Break

                Retesting,
Reporting to QA,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A copy of the Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Senior Management
• Quality Assurance
• Regulatory
• Quality Assurance Product Reviewers
• Production Management

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.