Deviation Investigation Training
This course is for younger professionals in the Pharmaceutical Industry and goes over an introduction to Deviation Investigations to handle problems and errors that come up in the pharmaceutical manufacturing process.
Target Audience
This course is suitable for the individuals who want to learn more about deviation investigations, including:
- Pharmaceutical Managers
- Team Leaders
- Quality Assurance
- Pharmaceutical Engineers and Scientists
- Manufacturing Personnel
Course Prerequisites
This course requires basic knowledge about the pharmaceutical industry and FDA/EU regulations associated with pharmaceutical manufacturing.
Objectives
This course will help you learn:
- What is a deviation and why deviation investigations are important.
- Sources (types and categories) of deviations.
- Regulatory Expectations for Investigations.
- How to plan for and navigate the investigation process, and schedule and conduct the key meetings.
- Some skills and tools of the effective investigator, to help you grow your skills to be successful in the investigation process.
Topics Covered
These are the following topics that will be covered:
- Overview of Importance of Investigations.
- Regulatory Expectations for Investigations.
- Investigation Process Overview.
- Roles and Responsibilities
- Investigation Planning, conducting the process, and conducting key meetings
- Skills such as interviewing, GEMBA walk, process flow mapping, Fishbone Diagrams, and 5Why
- More skills such as Active Listening, paying attention to body language, and technical reading comprehension
Course Modules
This course contains three modules that will focus on:
- Introduction to Deviation Investigations
- Investigation Process Overview
- Skills and Tools of the Effective Investigator
By the End of this Course
You will have the ability and self-assurance to effectively conduct thorough, accurate, and successful deviation investigations. You will be able to conduct your own investigations, bringing together cross-functional teams to investigate the true root cause of any problem.
Enroll Now
Enroll now for “Deviation Investigation Training” and learn how to investigate any problems found during the pharmaceutical manufacturing process. This is critical for protecting patient safety for the drug products we produce.
Introduction to Deviation Investigations
This is an introduction to deviation investigations, why they are important, and some of the types and categories of deviations.
This lesson talks about FDA and EU expectations for deviation investigations.
This is a review of FDA Warning Letters related to inadequate investigations.
Investigation Process Overview
This lesson goes over the roles and responsibilities in investigations and the classification levels.
This lesson goes over the elements of a thorough investigation process and planning for a successful investigation.
This lesson goes over the initial kickoff meeting, to make the deviation investigation a success.
This lesson goes over how to conduct the deviation investigation process.
Skills and Tools of the Effective Investigator
This lesson introduces some interviewing and exploration techniques the investigator can use.
This lesson goes over an introduction to root cause analysis.
This lesson explores some more techniques of the effective investigator.