Deviations and Issue Management Systems

Public / Private

SESSION TYPES

Virtual Class

Location

Intermediate - Expert

Skill Level

~8-10 Hours

Duration

€750

Public Session fee
(PER PERSON)

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Overview

Deviations and issues such as out-of-specification (OOS) test results, rework, and product returns present a significant challenge for the pharmaceutical industry. Product recalls cost billions of dollars and erodes brand trust. Most current approaches for handling issues lack maturity, traceability, or both. These deficiencies can introduce even more risk to the quality system.

In this workshop, you will learn the best practice framework for investigating any deviation in the product’s life cycle. You will improve your ability to detect, investigate, record and report deviations as they take place. In addition, you will learn how to incorporate “risk-based thinking” into the management of issues at the point of determination. Following the taught framework, you will eliminate the root cause of each deviation and know how to implement practical corrective actions.

After the workshop, you will be able to quickly identify an issue, thoroughly investigate it, and take the right action to ensure that quality standards are met.

completing this course will help you:

Who is the training 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.

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Topics

The topics can be adjusted and customized to your requirements.

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 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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