“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.
