Webinar for GMP Professionals

QA and CSV Effective Problem Solving Strategies During System Delivery

March 24, 2021
10:00-11:30 CET

Learn strategies for building effective working relationships between QA and CSV representatives to overcome common validation challenges. The strategies will help you improve system delivery, compliance, and harmony at the workplace.

Learn Strategies to Tackle Challenges that Arise During CSV Activities and resolve conflicts between stakeholders

Validation of computerized systems is a complex process that involves various stakeholders. Therefore, conflicts and frictions between the involved parties are common, especially if a project doesn’t go according to plan.

The conflicts usually result from the fact that each side has different objectives and responsibilities, which the other side is unaware of or doesn’t understand fully. 

The consequences of such disputes are grave and lead to:

  • project delays
  • waste of money
  • quality issues with deliverables
  • inadequate documentation

In the long run, the accumulated issues may lead to critical findings during audits and even loss of a license!

In this webinar, James will help you avoid the unpleasant situations by providing you a bird’s eye view of both parties’ perspectives and provide solutions to commonly occurring issues. 

After the webinar, you will be able to leave the “us versus them” mindset behind you. You will create long-lasting working relationships between the teams, navigating them in the right direction while solving problems and issues during any business system delivery. 

About James Ainsworth

James is a software developer who started supporting businesses with ERP deployment and CSV about 10 years ago. Besides the pharmaceutical and biotech sectors, James has experience consulting for companies in other highly regulated industries such as Automotive and Fintech. 

What You'll Learn

Starting positions and perspectives of CSV and QA representatives

Triggers that influence conflicts throughout the projects and how to manage them

Building a validation process that meets objectives

Who This Webinar is For

You are involved in introducing new computerized systems into your GMP-driven organization or updating documentation for current systems. You are part of the QA team responsible for overseeing the documentation throughout the project, or you are part of the CSV team on the ground, making sure the systems comply with regulations and user requirements. You are looking to understand the motives of other stakeholders and wish to work in a stress-free environment. Instead of getting involved in personal conflicts, you want to drive your organization towards operational success and compliance when dealing with computerized systems. 

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
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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.
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Why People Love Our Webinars

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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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. 

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If you still can’t find it, please contact us by the chat bubble on the right or our email address service@qualistery.com. 

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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.

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