Good Manufacturing Practices (GMP) Refresher and New Trends Course
Public / Private
SESSION TYPES
Virtual Class
Location
Beginner to Expert
Skill Level
~8 Hours
Duration
€750
Public Session fee
(PER PERSON)
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Course:
Overview
Compliance with good manufacturing practices is critical to the success of any pharmaceutical company. With over 9000 changes in the last three years alone, it’s challenging to stay up-to-date with all of the most crucial milestones of the cGMP.
You need to brush up yearly on your knowledge about GMP and how they protect the integrity of your products and company. New regulations are coming out all the time, and without a strong understanding of GMP, your organization is at risk for fines, production delays, or worse.
Many pharmaceutical companies get frustrated and overwhelmed when it comes time for a GMP refresher training because they don’t have the resources to create up-to-date training yearly.
You can stop worrying! This live virtual class will teach you everything you need to refresher your knowledge in the current good manufacturing practices (cGMP). You’ll understand why your work is so important and learn what’s changed recently in regulations.
After completing this course you will:
- Understand why GMP is so vital for our modern life
- Comprehend the complexity of the Pharmaceutical Quality System (PQS)
- Have a good understanding of the different regulations
- Learn about the latest changes and trends in regulations
Who is the training for?
The training is important for anyone who works in the GMP regulated environment. It’s is especially important for anyone working in the QA, QC, Production and Logistics.
Topics
The topics can be adjusted and customized to your requirements.
Learn about how GMP came to be and why it’s so vital for our life.
Learn about the 7-pillars of the Pharmaceutical Quality Systems (QMS)
Learn about the GMP requirements in regards to the qualification of the employees that work in a pharmaceutical environment.
We will discuss the difference between qualification and validation and their purpose. Then, we will go over all the required documentation and the stages of a successful validation and qualificaiton.
You will learn about the difference between an audit and an inspection and understand the expectations of the regulators.
We will cover both internal and external audits, and you will learn about all the phases of the audit.
Good documentation practice is vital for GMP. In this section we will cover all the important regulations and you will learn how to document correctly, avoiding the most common pitfalls.
We will also cover 21CFR part 11 and ALCOA.
Recently the PIC/S published Guidance PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments” on the topic of data integrity.
We will cover the essence of the document.
The FDA recently adopted the ICH Q12 Guideline after public input. This guideline was designed to supplement the existing guidelines by ICH Q8 – Q11.
We will cover the essence of the document and the main changes.
We’ll take a look at some interesting warning letters, and try to draw conclusions from them.
About the trainer
Yan Kugel
Yan is a GMP quality expert and the managing director at Qualistery GmbH. Through his vision, the company takes complex GMP topics and transforms them into engaging and enjoyable GMP training videos and training programs that captivate the audience. As a result, GMP professionals retain more information, which they can successfully use in their workplace. This is highly beneficial for the employer as for the career of employees.
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