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Management: Handling OOS Test Results and Completing Robust Investigations

Airport management ,Travel & tourism, Airport,Aviation Management

NetZealous LLC

Summary

Price
£170 inc VAT
Or £56.67/mo. for 3 months...
Study method
Online
Duration
2 hours · Self-paced
Access to content
6 months
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Additional info
  • Tutor is available to students

Overview

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.

Description

Why you should 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 webinar 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 the Session:

  • 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 is this course for?

  • QA Managers and Personnel
  • Analysts and Lab Managers
  • CAPA Management
  • Regulatory Affairs
  • Training Departments

Questions and answers

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Certificates

Certificate of completion

Digital certificate - Included

Reviews

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Legal information

This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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