Change Management Systems

This interactive and engaging online workshop will help you master the essential elements of Change Management Systems. By the end of this hands-on workshop, you will have the right tools and knowledge to deal with changes and implement Change Management Systems. Those new skills will take the operation at your workplace and your career to a new level.

Sessions:
05 – 08 July 2021 (4 hours per day)
or
22 – 25 November 2021 (4 hours per day)

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“If you want to make enemies, try to change something”

– Woodrow Wilson

The quote above is the unfortunate reality of our environment. Most people are afraid of change because it brings with it uncertainty. However, embracing change is the only way for advancement and improvement. In the GxP world, we face changes frequently when we introduce new products, correct failures, switch vendors, and adjust processes. Because of this, we must have robust Change Management Systems in place to make sure we complete all required actions timely and appropriately, without introducing new risk into the system.

If you don’t have good Change Management Systems in place, you can’t have adequate oversight over your processes and procedures. In such cases, it is easy to get in trouble with the regulators for inadequate documentation.

Therefore, to avoid such situations and to comply with regulations, you need to learn how to control and manage changes adequately. In this workshop, you will learn to manage and implement changes in

  • processes
  • manufacturing
  • testing
  • control
  • distribution

Also, you will learn the best practice framework for change management and understand how to apply the approach to all relevant areas of the product lifecycle and supply chain. That includes 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 manage and implement Change Management Systems in your department and across your organization. Those new skills will take the operation at your workplace and your career to a new level.

Topics

  • Overview of Change Management
  • How to write change proposals
  • Procurement process
  • Regulatory Affairs process
  • Impact & risk assessment
  • Role of Change management board
  • Project management
  • Implementing change
  • When to close a change control
  • Effectiveness checks
  • Failure of change
  • 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).

You must manage all changes appropriately to ensure that you have correctly assessed the impact and risk of each of them. To do that, you must understand the essential elements of change management.

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.

Start time: 09:00 CET

End time: 13:00 CET

1.445

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)

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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

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 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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