Good Manufacturing Practices (GMP) Introduction Course
4-5 April, 2022
10:00-15:00 CET (daily)
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, GMP Auditor and 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.
What people are saying
Are You Ready To join us?
Most frequent questions and answers
Yes! You will be able to see the trainer and communicate with him/her. You could use the chat function or raise your hand and speak through your microphone.
We use Zoom Meetings to simulate a real class! You will be able to see the speaker, other delegates and communicate with them.
You will get your individual access link immediately after your booking is finalized. If you don’t get the link within an hour, please check your spam folder.
The email title should be: “Webinar access link – Ticket Nr. XXX”.
If you still can’t find it, please contact us by the chat bubble on the right or our email address firstname.lastname@example.org.
If you didn’t get your link up to 48 before the live session, please contact us at email@example.com. We are quick to respond!
The quickest way to contact us on the day of the event is to use our website’s live chat. See the chat bubble on the right? We will be there live at your service to make sure everything goes smoothly for you.
Alternatively, you can message us at firstname.lastname@example.org.
We highly recommend you use your webcam and leave it on throughout the session. This will contribute to the “together” feeling and help the speaker see your reaction and adjust himself.
Please keep your microphone on mute during the session unless you raised your hand and given permission to talk by the hosts.
Please wear headphones to avoid echo and disturbances when you use your microphone.
IMPORTANT: Please note that the session is recorded, and you agree to that when you choose to turn on your webcam and use the microphone to communicate.
Yes, You will get a certificate of attendance and the slides within 72-hours after the course. If you don’t get it after that time, please check your spam folder.
If you still can’t find it, please contact us through the chat bubble on the right, or by email email@example.com.
Yes, no problem! Please inform us about the name change, so we know to admit the person to the webinar and update the name on the certificate.