Good Manufacturing Practices (GMP) Introduction Course
Public / Private
Public Session fee
Good Manufacturing Practices (GMP) help ensure that your company’s products are safe, effective, and legal and ethical. All employees in the pharmaceutical industry must understand and implement GMP in their activities. However, it’s hard to understand what really matters and how everything connects with so much information to take in.
During this live virtual class, you will learn what GMP is and how it impacts your company. We will also cover the seven pillars of the pharmaceutical quality system and see how they ensure the patient’s safety and health. You’ll also gain a good understanding of the essential regulations in this industry and how to comply with them.
Join us for training, and you’ll have a comprehensive understanding of GMP and the knowledge of how to apply them at your workplace.
After completing this course you will:
Who is the training for?
The training is important for anyone who works in the pharmaceutical industry or serves it. This includes ISO 9001 certified suppliers to the pharma industry.
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.
- Learn about the requirements and the responsibilities of the Quality Unit.
- Understand the difference between the QA and the QC departments.
Learn about what the regulations expect from the various facilities in pharma. We will discuss the manufacturing floor, the labs, warehouses and auxiliaries.
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.
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.
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.
The suppliers to the pharmaceutical company are critical for the quality of the product.
You will learn about the stages of supplier qualification and the different categories of materials and suppliers.
About the trainer
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.