Good Manufacturing Practices (GMP) Introduction Course

Public / Private

SESSION TYPES

Virtual Class

Location

Beginner

Skill Level

~8 Hours

Duration

€750

Public Session fee
(PER PERSON)

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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. 

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. 

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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.

About the trainer

Yan Kugel - Qualistery

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.

What people are saying

Àngels Llarch
Àngels LlarchPharmacist
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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
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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
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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
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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
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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
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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
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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.
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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.
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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
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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.
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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.
Floriana Vetrano
Floriana VetranoChemical engineer
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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
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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
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Yan Kugel Alex Hall, thank you for the informative webinar. You did a nice job👏
Amritha Mukundan
Amritha MukundanQuality Control Professional
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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
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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.
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