How to Master Remote GMP Audits and When to Avoid Them

Time

18:00 - 19:30

Date

Feb 24 2022
Expired!

Learning Type

Free Live Webinar

Overview

The Covid-19 pandemic has almost eliminated onsite regulatory and supplier audits. It brought compliance uncertainty upon both regulators and manufacturers. 

A new type of audit has emerged through evolution- The Remote Inspection. 

Now that we are (hopefully!) nearing the end of the pandemic, one question remains- will the Remote Inspections stay with us or disappear? 

Most likely, it will stay with us to some degree, as it has some benefits. Furthermore, the industry will most certainly adopt a mixed approach.  

However, it means confusion and chaos for inexperienced auditors and auditee’s. 

Virtual audits present new challenges and dilemmas, such as: 

  • What types of audits are ideal for remote inspection, and which should you do only onsite? 
  • How to deal with and manage document review effectively? 
  • How to overcome technical issues, and what backup plans should you have? 
  • What to do when the auditee doesn’t want to cooperate?

In this webinar, you will learn to answer the questions above and more. You will get practical advice and recommendations for preparedness and how to conduct virtual inspections effectively. 

The speaker for this webinar, Fenton Fong, is a seasoned GMP manufacturing/compliance consultant expert. He has conducted a wide variety of compliance audits throughout his career and transitioned to having conducted over 20 remote inspections since 2020.  

He will provide practical advice and lessons from the pandemic and the near return to onsite auditing.

After attending the webinar, you will have more confidence in the upcoming remote audits’ preparations and execution. Additionally, you will know how to mix it up better with remote and onsite audits. 

  • Who Should Attend:

    Quality professionals, quality compliance groups, and fellow GMP inspectors.

  • Skill Level: Intermediate , Expert
  • Topics:

    Agenda:

    1. Types of audits that are ideal for remote audit format 
    • Risk assessment 
    • Criticality of the audit subject 
    • Auditee standards/policies/procedures 
    1. Preparation for and managing document reviews 
    • Hard copy vs. electronic 
    • Active vs. passive scrolling access
    • Screen space 
    1. Video interfacing, live virtual tours, and backup plans 
    • Site tours and floorplan drawings 
    • To turn the camera on or off, that is the question! 
    • Reading the lay of the land 
    1. Return to onsite auditing 
    • Daily testing with rapid test kits 
    • Onsite positive test results 
    • Will we return to complete onsite inspections?

Speaker

  • Fenton Fong
    Fenton Fong

    Fenton Fong is a Biotech/pharma industry professional with 30 years of corporate and consulting experience in CMC/manufacturing and Quality/Compliance. Fenton is a Founder and Principal at xCellarate, an industry consulting firm based in Canada, and provides value-added solutions to Biotech/Pharma, Medical Devices clients in Canada/USA, Asia.

Qualifyze

Partner

Qualifyze
Website
http://www.qualifyze.com

The Qualifyze mission is to build the trust layer for global supply chains by creating a digitally connected ecosystem. They operate the first online platform for GxP audits that connects pharma companies, suppliers, and auditors.

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
Read More
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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  • Timezone: Asia/Singapore
  • Date: Feb 25 2022
  • Time: 01:00 - 02:30

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