How to properly investigate Out Of Specification / Out Of Trend (OOS/OOT) Results
WebcastFaculty
OVERVIEW
How to properly investigate Out Of Specification / Out Of Trend (OOS/OOT) Results is organized by Compliance Global Inc and would be held on Jul 28, 2017.
The target audience for this event for Quality Assurance/Quality Control Directors, Managers, and Specialists Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists, Quality Control Laboratory Staff.
Course description : -
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations
Areas Covered in this Webinar : -
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
Conference Objectives : -
Learn the responsibilities of Analysts and Supervisors
Listen to what the FDA looks for in terms of Human Errors
Describe when a Full Investigation should be triggered
Describe the frequency for Re-testing and Re-sampling
Learn how to implement the corrective and preventive action plans (CAPA)
Additional details will be posted as soon as they are available.
The target audience for this event for Quality Assurance/Quality Control Directors, Managers, and Specialists Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists, Quality Control Laboratory Staff.
Course description : -
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations
Areas Covered in this Webinar : -
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
Conference Objectives : -
Learn the responsibilities of Analysts and Supervisors
Listen to what the FDA looks for in terms of Human Errors
Describe when a Full Investigation should be triggered
Describe the frequency for Re-testing and Re-sampling
Learn how to implement the corrective and preventive action plans (CAPA)
Additional details will be posted as soon as they are available.
SPECIALITIES
Quality ManagementQuick Links