Master Class: Managing Deviations From A to Z

In this live online GMP master class, you will learn how to handle deviations efficiently from start to finish. You and your department will be more effective in dealing with deviations, have less stress, and much more peace of mind!

The reason for that is that our master class’s goal is to teach you the right framework to reduce the overall number of deviations you have to deal with daily. And when you need to deal with some, you will know how to do it much quicker and more effectively.

The master class consists of three live online GMP training courses:

  1. Deviations and Issue Management Systems (8 hours)
    • 27 – 28 July 2021 (4 hours per day)
  2. Corrective Actions and Continual Improvement Management System (8 hours)
    • 21 – 22 September 2021 (4 hours per day)
  3. Root Cause Analysis Process (16 hours)
    • 01 – 04 June 2021 (4 hours per day)

Each lesson begins at 09:00 and ends at 13:30 CET.
Every day consists of 4 hours of training + 30 minutes break.

 

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Deviations have a significant impact on the product life-cycle, your own KPI’s and the company’s overall success. 

If you don’t handle deviations efficiently and correctly you: 

  • risk a patient’s lives,
  • will have compliance problems with regulators,
  • waste unnecessary time on repeating events,
  • lose control over your process,
  • and have endless stress in the work environment.

Therefore, you need to master all the aspects of dealing with deviations and issues that arise during the product life-cycle. 

It means:

  • Approaching and documenting deviations efficiently and correctly,
  • investigating the root cause analysis thoroughly,
  • and generating effective CAPAs,
  • thus, building a robust continuous improvement system around your processes. 

You will manage all that by taking part in this master class, which consists of three live online GMP courses: 

  1. Deviations and Issue Management Systems (8 hours)
  2. Root Cause Analysis Process (16 hours)
  3. Corrective Actions and Continual Improvement Management System (8 hours)

After finishing this master class, you will:

  • Know how to document deviations and CAPAs clearly and quickly.
  • Learn how to perform an efficient root cause analysis, which tools to use, and document it correctly. 
  • Understand how to establish an excellent continual improvement system that will take your process to the next level.
  • Encounter much less repeating issues.
  • Have less stress and more peace of mind.

Topic: Deviations

  • The deviation/investigation Process
  • The correct way to document deviations
  • How to perform effective Impact/Risk assessment
  • How to efficiently investigate events
  • How to design effective CAPAs and follow-ups
  • Implementation of Deviation/investigation process

Topic: CAPAs

  • CAPA process overview
  • Sources of CAPA and documentation
  • SMART actions
  • Status reporting/rescheduling
  • Effectiveness checks
  • Implementation of a CAPA process

Topic: RCA

  • 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

The workshop will allow you to align yourself with all the requirements of ICH Q10 and ISO 9001:2015 regarding events investigation.

Dates & Time

Deviations and Issue Management Systems Workshop

Sessions:
18 – 19 January 2021 (4 hours per day)
09:00-13:00 (CET)

Corrective Actions and Continual Improvement Management System Workshop

Sessions:
21 – 22 September 2021 (4 hours per day)
09:00-13:00 (CET)

Root Cause Analysis Process Workshop

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

 

2.435

Plus 19% VAT

Limited Spots Available

You will be able to select suitable session dates during checkout.

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)

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