A Workshop for GMP Professionals
Deviations and Issue Management Systems
May, 18-19 2021 (4.5 hours per day)
09:00-13:30 CET
Speaker: Alex Hall
In this workshop, you will master the essential elements for investigating deviations that arise during the product life cycle of medicinal products and learn how to document and address them much more effectively. At the end of the 2-day session, you will know how to reduce the reoccurrence of deviations in your organization and minimize overdue issues in the QMS. As a result, you will boost your compliance, improve KPI, and save much time and money in the process.
Learn a best-practice framework for analyzing deviations and implementing corrective actions
Mishandling deviations and failing to investigate them correctly can lead to serious compliance problems. Hence, regulators can shut-down your operation in a blink of an eye. Additionally, not addressing deviation properly leads to reoccurring issues, which waste time and are a killer of productivity. Therefore, each GMP professional must know the correct framework to deal with such issues quickly and effectively.
This interactive workshop covers the essential elements for investigating issues that arise within a product’s life cycle. It includes the manufacturing, testing, control, and distribution of medicinal products.
It provides a best practice framework for analyzing deviations and implementing corrective actions. Additionally, it teaches you approaches to apply to all relevant areas of the product life cycle and supply chain, which includes:
- Product quality complaints,
- audit findings,
- laboratory Out of Specification / Out of Trend results
The approaches will help you:
- document deviations quicker and more effectively,
- drive continual improvement to your systems,
- reduce the number of reoccurring deviations,
- minimize the number of overdue deviations in the system
- become more effective and reduce stress.
About the Trainer
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 You'll Learn
The deviation investigation Process
The correct way to document deviations
How to perform effective Impact/Risk assessment
How to efficiently investigate events
How to design effective CAPAs and follow-ups
Implementation of Deviation/investigation process
Who This Workshop is 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.
What People Say About Our Webinars
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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.
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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
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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.
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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!
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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.
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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
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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.
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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.
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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.
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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!
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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.
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Yan KugelQualistery GmbH #thanks for webinar
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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!
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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 👏
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Yan Kugel Alex Hall, thank you for the informative webinar. You did a nice job👏
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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.
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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 Online GMP Training
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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Days
Hours
Minutes
Seconds
Workshop Seat
Only 20 seats available€765
€ 350
Excl. VAT -
Live session
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Q&A
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Exercises in breakout rooms
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Certificate of attendance
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Workbook
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Presentation copy (post event)
Early Bird
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.
The email title should be: “Webinar access link – Ticket Nr. XXX”.
If you still can’t find it, please contact us by the chat bubble on the right or our email address service@qualistery.com.
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.
Yes, no problem! Please inform us about the name change, so we know to admit the person to the webinar and update the name on the certificate.
Sure! Get in touch with us to discuss the details.
service@qualistery.com
