Early Bird

Root Cause Analysis Process

When you encounter deviations, you should investigate their root cause adequately, no matter how minor it is. Otherwise, you will have to face those deviations, again and again, wasting time, money and be stressed all the time.

This interactive and engaging online workshop will help you master the essential elements of a Root Cause Analysis. By the end of this hands-on workshop, you will have the right tools and knowledge to investigate any issue that will arise within a product’s life cycle. The result- less repeating deviations, better KPIs, and more time to concentrate on the important projects.

Date and Time:
01 – 04 June 2021 (4 hours per day)
09:00-13:00 CET

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How many times have you seen ‘no root cause found’ in the result of a root cause analysis (RCA)? Is this the case? Very often, people don’t invest enough time to conduct a proper root cause analysis. Consequently, it leads to incorrect corrective actions and repeated issues.

When you perform root cause analysis inadequately, you put patients at risk and may get in trouble with regulators. Those repeated deviations waste time, money, and cause a lot of stress.

Therefore, to avoid such situations and comply with regulations, you need to understand the importance of a good root cause analysis and master the tools to perform it. This workshop covers the essential elements for conducting a successful RCA as part of the investigation of issues that arise during:

  • manufacturing
  • testing
  • control
  • distribution

You will also learn the best practice framework for RCA and understand how to apply the approach to all relevant areas of the product lifecycle and supply chain. Such areas include product quality complaints, audit findings, and laboratory Out of Specification and Out of Trend results.

By the end of this hands-on workshop, you will have the right tools and knowledge to perform a successful RCA to investigate any event. Those new skills will take the operation at your workplace to a new level, reducing deviations and improving KPIs.

Topics

  • Root Cause Analysis Overview
  • Correct Documentation of RCA
  • Impact / Risk assessment
  • Team set up and planning
  • Defining the problem
  • Process flow map
  • IS / IS NOT
  • Cause and Effect
  • 5-Whys
  • Fault tree analysis
  • Root Cause and Causal Factors
  • Embedding the process

Target Group

This course is of particular importance to quality professionals in all GxP fields (pharma, medical devices, cosmetics, dietary supplements, and food).

It is essential that you investigate all issues, errors, and near misses. Only that way, you can make sure that you have addressed impact and risk correctly and assigned relevant corrective actions to prevent future failures.

Event Details

The workshop lasts about 16 hours and spreads across four days.
That way, you don't get overwhelmed with too much information at once. Also, you can get back to your urgent projects after your launch break.

01 - 04 June 2021 (4 hours per day)
09:00-13:00 CET

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First day of the  4 -day workshop:

Date: June 1, 2021

Start time: 09:00 CEST

End time: 13:00 CEST

Venue: Virtual Event

Email: service@qualistery.com

1.445 1.355

Plus 19% VAT

Limited Spots Available

Your Instructor

Alex Hall

QP Trainer & Consultant

Alex is an expert in Pharmaceutical Quality Assurance with 30 plus years in the pharma industry, 20 of those as a Qualified Person. As an instructor, Alex builds on her experience and her previous role as a UK QP Assessor to support QA professionals and QP trainees. She helps trainees achieve the best results through supportive coaching, mentoring, and a straightforward training approach.

You can learn more about Alex from her appearance on The Qualitalks Podcast:

1. When You Deal With Risk, Don’t Be a Firefighter!

2. The Role of the Qualified Person (QP)

What People Say About Our GMP Online Training

Our online interactive workshops will be presented to you live through a specialized classroom platform. You will be able to attend from home or work, yet feel like we share the same room.

Live Online
GMP Training

Communication

See and communicate with the tutor through a webcam and chat

Interactions

Raise your virtual hand to ask questions

Activities

Partake in polls and quizzes

Teamwork

Participate in exercises with other delegates

How can we be of service?

We are Here to provide you with state of the art gmp training

What are your requirements?

Feel free to contact us, and we will be more than happy to answer all of your questions and address all your needs. 

Let us Know Your Needs

Please share with us several suitable dates for private training sessions and the number of attendees. We will get back to you with a customized offer as soon as possible. 

Wait, don't leave empty-handed!​

Download our free Ultimate FMEA Guide, which is dedicated to GMP and pharma professionals.

This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.

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