A Workshop for GMP Professionals

Deviations and Issue Management Systems

May, 18-19 2021 (4.5 hours per day)
09:00-13:30 CET

Speaker: Alex Hall

In this workshop, you will master the essential elements for investigating deviations that arise during the product life cycle of medicinal products and learn how to document and address them much more effectively. At the end of the 2-day session, you will know how to reduce the reoccurrence of deviations in your organization and minimize overdue issues in the QMS. As a result, you will boost your compliance, improve KPI, and save much time and money in the process. 

Learn a best-practice framework for analyzing deviations and implementing corrective actions

Mishandling deviations and failing to investigate them correctly can lead to serious compliance problems. Hence, regulators can shut-down your operation in a blink of an eye. Additionally, not addressing deviation properly leads to reoccurring issues, which waste time and are a killer of productivity. Therefore, each GMP professional must know the correct framework to deal with such issues quickly and effectively.

This interactive workshop covers the essential elements for investigating issues that arise within a product’s life cycle. It includes the manufacturing, testing, control, and distribution of medicinal products.

It provides a best practice framework for analyzing deviations and implementing corrective actions. Additionally, it teaches you approaches to apply to all relevant areas of the product life cycle and supply chain, which includes:

  • Product quality complaints,
  • audit findings,
  • laboratory Out of Specification / Out of Trend results

The approaches will help you:

  • document deviations quicker and more effectively,
  • drive continual improvement to your systems,
  • reduce the number of reoccurring deviations,
  • minimize the number of overdue deviations in the system
  • become more effective and reduce stress.

 

About the Trainer

Alex Hall​

Alex Hall​

Alex is an expert in Pharmaceutical Quality Assurance with 30 plus years in the pharma industry, 20 of those as a Qualified Person. As an instructor, Alex builds on her experience and her previous role as a UK QP Assessor to support QA professionals and QP trainees. She helps trainees achieve the best results through supportive coaching, mentoring, and a straightforward training approach.

What You'll Learn

The deviation investigation Process

The correct way to document deviations

How to perform effective Impact/Risk assessment

How to efficiently investigate events

How to design effective CAPAs and follow-ups

Implementation of Deviation/investigation process

Who This Workshop is For

This course is of particular importance to quality professionals in all GxP fields (pharma, medical devices, cosmetics, dietary supplements, and food).

If you have to deal with and investigate errors, this workshop is for you.

In a GxP environment, you must examine all issues, errors, and near -misses appropriately. That way, you can ensure that you have correctly assessed the impact and risk, assigned relevant corrective actions, and prevented future issues. This workshop will teach you how to do that most efficiently.

What People Say About Our Webinars

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
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.
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Why People Love Our Online GMP Training

We believe that GMP training should be simple, effective, and fun. Instead of slides full of text, we implement visual storytelling and carefully evaluate every word and image we put in our presentations. Your experience during the session drives us to provide you the best content, and your success and satisfaction are our joy.

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Days
Hours
Minutes
Seconds

Workshop Seat

Only 20 seats available
€765
350 Excl. VAT
  • Live session
  • Q&A
  • Exercises in breakout rooms
  • Certificate of attendance
  • Workbook
  • Presentation copy (post event)
Early Bird

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. 

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@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. 

You will get everything that is included in your package within 72-hours after the webinar. 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. 

Sure! Get in touch with us to discuss the details.

service@qualistery.com

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