How to Pick the Right Tools for a Successful Risk Management


16:00 - 17:30


Jan 26 2022

Learning Type

Free Live Webinar


Many pharma and medical device professionals lack a structured and repeatable process for risk assessments. Instead, they carry out risk assessments in a patchy and irregular manner, using FMEA as a default tool. 

Risk Management is not only a set of tools; it is also an opportunity for process improvement. A structured, repeatable process that uses the right tools will improve quality, boost productivity, and minimize deviations and observations.

Join this webinar to learn everything you need to know about risk assessments and carry out a GMP compliant one. At the end of the webinar, you will be confident that you know what approach to take and what tools to use for a successful and meaningful risk assessment. 

The webinar will help you…

  • decide on the best approach for Risk Management on case to case basis,
  • choose the right Risk Management tools for your purpose,
  • avoid unnecessary deviations and audit observations,
  • maintain a solid and compliant GMP quality system.

Who Should Attend?

You should attend if you use risk management techniques as part of your role and would like to discuss use cases to enhance your knowledge to understand better the topic and why there is more to risk assessments than a simple FMEA.

  • Skill Level: Intermediate
  • Topics:
    • Executive summary for regulators and industry
    • Background
    • History
    • Content
    • Tools - overall notes
    • Basic Risk Management Facilitation Methods
    • Failure Mode Effects (Criticality) Analysis (FMEA & FMECA)
    • Fault Tree Analysis (FTA)
    • Hazard Analysis and Critical Control Points (HACCP)
    • Hazard Operability Analysis (HAZOP)
    • Preliminary Hazard Analysis (PHA)
    • Risk Ranking and Filtering
    • Supporting Statistical Tools
    • Combination of Tools
    • Application - overall notes
    • Integrated Quality Management
    • Regulatory Operations
    • Development
    • Facilities, Equipment and Utilities
    • Materials Management
    • Production
    • Laboratory Control and Stability Studies
    • Packaging and Labelling


  • Paul Palmer
    Paul Palmer
    Quality & Regulatory Consultant

    Paul is an expert in Pharmaceutical manufacturing and supply chain oversight. He started in 1986 at a manufacturing site with a diverse portfolio of products including, medicinal products (aka pharmaceuticals), medical devices, cosmetics, and casting products. He has maintained the diversity working with all dosage forms from GLP formulation and clinical trials to commercial manufacture and generic the entire product lifecycle throughout his career. Paul has been an active Qualified Person releasing products since 2004 and continues to do so now. He enjoys experiencing a diverse lifestyle that includes teaching various subjects and sharing his knowledge online.

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!
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.
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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.

Are You Ready To join us?

Event Registration

Local Time

  • Timezone: Asia/Singapore
  • Date: Jan 26 - 27 2022
  • Time: 23:00 - 00:30

*Please double-check the correctness of the information, such as email and full name. It is used for providing personal access link and issuing the certificate of attendance. 

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4 thoughts on “How to Pick the Right Tools for a Successful Risk Management”

      1. Santiago Balarezo

        7 It’ll be a great opportunity to understand the Risk Mangment apply to pharmaceutical industries.

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