How to properly investigate OOS/OOT Results

Website http://bit.ly/2ru2Sae | Edit Freely

Category cyber crime investigation;gmp compliance audit checklist

Deadline: July 28, 2017 | Date: July 28, 2017

Venue/Country: New York, U.S.A

Updated: 2017-06-26 18:26:10 (GMT+9)

Call For Papers - CFP

The speaker will provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

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.

Why Should You Attend

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

Learning 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)

Who Will Benefit

Quality Assurance/Quality Control Directors, Managers, and Specialists

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists

Quality Control Laboratory Staff

For more detail please click on this below link:

http://bit.ly/2ru2Sae

Email: referralscomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Fax: +1-516-900-5510