Conducting investigations in pharmaceutical industry.
What you'll learn
Developing the investigation skills,You will able to understand investigation strategies, OOS, OOT, human error investigations
You will become investigator in the organisation
you will be in compliance to regulatory requirements
This course is self made for personal upgradation in pharmaceuticals
Requirements
The person should be full focussed during the session.
Description
This video will help viewers to understand why training on the investigation process is required. Further, you will understand in brief about types of investigation tools and how to achieve compliance by recording the use of specific investigation tool/s. Also, the viewers will understand the common errors by some persons during the investigation.The next lecture will help to understand about out- of specification(OOS) results, FDA requirements for OOS investigation, Phase 1 and Phase 2 investigations, some examples of FDA citations, common problems of OOS, Outlier tests, Retesting and Resampling considerations, and Practical examples of three sigma and six sigma for Out of trend evaluationThis next lecture will take you through understanding the consequences of Human errors, how to investigate human errors, and furthermore, the ways to reduce human errors. During this session, different models like the Swiss cheese model, and four quadrant models also will be discussed.The next lecture will help you to learn about Good Review practices. This training will include, some examples of FDA citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more.There is a small video lecture that will help viewers to understand Quality Risk Management principles, how it is simple and easy to implement, and achieve the compliance level. We have explained this with simple examples.
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 OOS and OOT investigation
Lecture 3 Human errors investigation and reduction strategies
Lecture 4 Good Review Practices
Lecture 5 Quality Risk Management
Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.
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