The Fundamentals of an Effective and Compliant Thermal Validation

Time

16:00 - 17:30

Date

Mar 22 2022
Expired!

Learning Type

Free Live Webinar

Overview

Thermal validation is a critical part of ensuring that temperature-controlled units are consistently reliable and accurate. Incorrect validation can lead to harsh regulatory consequences and harm the end consumer. 

Unfortunately, many pharma professionals find thermal validation overwhelming as very little practical guidance is available in the regulations. The actual pragmatic implementation of the guidelines can be heavily based on experience with the regulatory bodies. 

Jakob, the speaker at this webinar, has designed it specifically to take the mystery out of regulatory requirements and deliver concise information on meeting the regulators’ expectations.

Jakob Konradsen has extensive experience in thermal validation projects- from temperature-controlled units to large-scale warehouses and transport vehicles. He works with companies to ensure thermal compliance to their internal and regulatory requirements, constantly adapting a risk-based approach. 

This webinar will give you a great understanding of the fundamentals of thermal validation. We will also provide examples of practical implementation of the different elements, ensuring you comply with the regulatory requirements.

By the end of the webinar, you will better understand the requirements set forth by the regulatory bodies and have better confidence in choosing a thermal validation strategy.

  • Who Should Attend:

    Quality professionals and anyone who is working with temperature-controlled units. Be it smaller temperature chambers, fridges, and freezers, to more giant warehouses that wish to learn how to prepare, perform and document thermal validation activities, or better understand the different elements.

  • Skill Level: Novice, Intermediate
  • Topics:

    1.1 Regulatory requirements and guidelines 

    • cGMP 
    • Eudralex 
    • FDA requirements 

    2.1 The structure of a mapping/documents 

    • User requirements 
    • Mapping protocol 
    • Mapping execution 
    • Mapping report 

    3.1 Making the mapping protocol 

    • Considerations 
    • Defining the requirements 
    • Planning the mapping 
    • Risk-based approach 

    4.1 Real-life examples of implementing a risk-based approach to mapping strategy 

    • Process risks 
    • Compliance risks 
    • Technical risks

Speaker

  • Jakob Konradsen
    Jakob Konradsen
    Co-founder and Head of Quality at Eupry

    Jakob Konradsen has a background in electrical engineering and has worked with quality and validation for his entire work life. Jakob has broad experience within the thermal validation and calibration field, emphasizing temperature validation of everything from temperature-controlled units to large-scale warehouses and transport vehicles. Jakob is passionate about finding solutions that balance regulatory requirements with a cost-effective and pragmatic approach and a risk-based approach.

Eupry

Partner

Eupry
Email
contact@eupry.com
Website
https://eupry.com/

Eupry provides a complete suite of solutions to monitor and perform validation of temperature, CO2, humidity, and differential pressure for regulated industries. Eupry runs an accredited ISO/IEC 17025 calibration laboratory. Their innovative and patented products are constantly pushing the industry's limits.

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.
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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.
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Event Registration

Local Time

  • Timezone: Asia/Singapore
  • Date: Mar 22 - 23 2022
  • Time: 23:00 - 00:30

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