Good Manufacturing Practices (GMP) Introduction Course

arrow-icon-size3 Reserve your seat

4-5 April, 2022

Date

10:00-15:00 CET (daily)

tIME

Beginner- Intermediate

Skill Level

~10 Hours

Duration

€750

Plus 19% Tax

Public Session fee
(PER PERSON)

The public session is sold out. Please inquire about private sessions here. 

Share This
Course:

Overview

 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. 

arrow-icon-size3 Reserve your seat

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
  • Hold an extensive knowledge of the main GMP activities in the pharmaceutical production
  • Know how to work in compliance with cGMP

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. 

arrow-icon-size3 Reserve your seat
Play Video

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. 

  • 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.

arrow-icon-size3 Reserve your seat

About the trainer

Yan Kugel - Qualistery

Yan Kugel

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.

Linkedin
arrow-icon-size3 Reserve your seat

What people are saying

Àngels Llarch
Àngels LlarchPharmacist
Read More
Honestly, I thought it would be a kind of refreshment training. Thank you for the quality of the content, the motivation, and for making us vibrate as if we were in the same classroom. ‎
Olivera Tatalovic PMP, CSSGB, Economist
Olivera Tatalovic PMP, CSSGB, EconomistQuality Assurance * Regulatory Projects, Operations & Compliance * EU and MENA region * An alumna of Pfizer & Smith+Nephew
Read More
Thank you Alex Hall and Yan Kugel for one more training with really valuable content provided. I have thoroughly enjoyed it. #qms #qualityassurance
Avanish Kansara
Avanish KansaraQA Manager at Althea
Read More
Thanks Yan & Alex for organising this event. It was great learning and knowledge sharing by Alex and QA experts from all over the world on how CAPA plays important role in improving Quality System. Looking forward for upcoming events to learn other aspects of Quality System and improving myself.
Victoria De La Mare
Victoria De La MareQuality Assurance Specialist
Read More
Yet another very informative session with Alex Hall and Yan Kugel. Extremely useful pointers for change control and deviation management. Thank you once again!
Ramya Raghavendra
Ramya RaghavendraQuality Control Specialist (Stability) at Seqirus
Read More
Thank you, Yan Kugel and Alex Hall for the opportunity to be a part of an amazing and informative webinar with Qualistery GmbH.
Dayna Gabell-Jopson BSc RSci
Dayna Gabell-Jopson BSc RSciQuality Assurance Officer at Bray Group
Read More
Fantastic webinar, very informative, lots of novel ideas and it was run at a good pace. Alex is also very entertaining and makes Quality fun! Thank you Alex Hall, Yan Kugel and Qualistery GmbH #quality #webinar
Jenifer Anigbogu
Jenifer AnigboguQuality Assurance, Regulatory affairs, and Export specialist at Metrovision
Read More
Thank you to Yan Kugel, Alex Hall and Qualistery GmbH for organising this webinar on how to continually improve your quality system - a very engaging and informative presentation.
Sona Ledinia
Sona LediniaFresh Graduate Pharmacist | Passionate and enterprising in being more knowledgeable and skilful in the Pharmaceutical Industry.
Read More
I had a chance to joined a great!, great training webinar by Qualistery GmbH about "How To Take Control Over Your Deviations". Thanks to Yan Kugel, Alex Hall and Qualistery GmbH for giving me this opportunity to acquire such valuable information and mindset to have in maintaining the Quality. Deviations surely the important matter to control so we could get the safest and the best quality we want.
Stefano De Blasis
Stefano De BlasisSite Compliance Specialist (Regulatory Affairs) in Pfizer Italia S.r.l.
Read More
First rule in this dynamic world: Never stop learning! 💪 Thanks to Yan Kugel and Qualistery GmbH for the opportunity to partecipate to this webinar.
Annalisa D'orazio
Annalisa D'orazioQuality Assurance Specialist at GSK
Read More
Another great session about best practices on How to take control over deviations! Very grateful to receive insights on how to reduce the number of reoccurring deviations and improve KPI's, avoiding waste of time and reducing risk. Thanks to Alex Hall Yan Kugel Qualistery GmbH I really invite to have a look on upcoming sessions!
아템켕에드몬드
아템켕에드몬드Quality Assurance Manager at Medytox Inc.
Read More
Much appreciation to Yan Kugel and the team at Qualistery GmbH for putting together this training. The training material and manner of presentation was truly unique in its own captivating the audience and naturally increases attention span and concentration through out the session.
Katerina Arsova Manchevska
Katerina Arsova ManchevskaQuality Assurance Manager at NYSK Holdings, LLC
Read More
Yan KugelQualistery GmbH #thanks for webinar
Floriana Vetrano
Floriana VetranoChemical engineer
Read More
Thanks Yan Kugel, Alex Hall and Qualistery GmbH for the Great Webinar “ How To Take Control Over Your Deviations” with very useful insight on Issue Management and Recurring Deviations! Well done!
Martina Gjorgjevska
Martina GjorgjevskaQuality Assurance Pharmacist at VARUS
Read More
Thank you all for this great webinar. It was really insightful with great tips to implement in our quality system. Continue with the great work 👏
Nadica Mireva Popovska
Nadica Mireva PopovskaResearch And Development Manager at Galafarm
Read More
Yan Kugel Alex Hall, thank you for the informative webinar. You did a nice job👏
Amritha Mukundan
Amritha MukundanQuality Control Professional
Read More
The training I attended was excellent. The instructor was very knowledgeable and shared great insights that I definitely plan to use. I am looking forward to the next Webinars and Workshops.
Ahmad Al Turman
Ahmad Al TurmanQuality Control Compliance Supervisor at MS PHARMA
Read More
Qualistery has an attractive way to preset their topics. Additionally, the explanations by the trainer were simple and wonderful. I wish you progress and success as I await what comes next.
Miguel Enseñat Mestre
Miguel Enseñat MestreGlobal Production manager and Logistics manager en Labolife España S.A.
Read More
SOPs are the basis for maintaining the consistency and quality of a process, thanks to Qualistery GmbH Yan Kugel and Yogesh Krishan Davé for giving us the opportunity to receive valuable information in a convenient way.
Previous
Next

Are You Ready To join us?

arrow-icon-size3 Reserve your seat

FAQ

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 service@qualistery.com. 

If you didn’t get your link up to 48 before the live session, please contact us at service@qualistery.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 info@training.qualistery.com.

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 service@qualistery.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. 

Register Now

Inquiry Form For private session

More Courses

You might also be interested in these courses

Course 2

How to build a successful email newsletter

Lorem ipsum dolor sit amet, consectetur adipiscing elit. aulla sit amet magna sodales, interdum tortor etlert of dictum mauris loean ultricies lectus quis gravida urna interdum quam bibend.

How to build a successful email newsletter

5 lessons - 4:11 hours
View Course

Course 3

How to use online reviews to boost your business

Lorem ipsum dolor sit amet, consectetur adipiscing elit. aulla sit amet magna sodales, interdum tortor etlert of dictum mauris loean ultricies lectus quis gravida urna interdum quam bibend.

How to use online reviews to boost your business

5 lessons - 4:11 hours
View Course

Wait, don't leave empty-handed!​

Download our free Ultimate 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.

Get the Guide
img-22
img-23

Get Informed About

Free Webinars &
Industry Insights

Subscribe to our newsletter

Maybe Later