Integrity of Quality and the Quality of Data Integrity

Time

16:00 - 17:30

Date

Oct 26 2022

Learning Type

Free Live Webinar

Overview

Product quality is fundamental in regulated industries such as the pharmaceutical, food, and cosmetics industries. Furthermore, the proof of quality depends on reliable data.

Not maintaining healthy data reliability (Data Integrity) can lead to a rough consensus with regulators.

Health authorities have written methodical official guidelines, such as 21 CFR Part 11, to ensure that manufacturers present them with reliable and accurate data to justify their decision-making. And since 2013, the authorities have been updating other core guidelines to focus on Data Integrity more than ever before.

Although the requirements are loud and clear, we still find that the managers in charge of deploying the principles face challenges that arise from multiple gray areas.

Therefore, Data Integrity training became mandatory for any organization committed to this subject.

In this webinar, we will explore ways to implement Data Integrity principles within the organization fundamentally and use them as internal training.

We will discuss the principles represented by ALCOA(+), which you can also apply to everyday decisions. As such, it strongly relates to the organizational quality culture and the successful deployment of quality processes.

The webinar includes a historical overview of the development of the requirements and Data Integrity principles dealing with maintaining the quality and reliability of data.

It includes a comparison of the various regulations, as well as recommendations for the successful implementation of a shared organizational culture.

By the end of the webinar, you will be able to explain and account for the rationale behind the required Data Integrity regulations.

  • Who Should Attend:

    Quality Professionals

  • Skill Level: Novice, Intermediate , Expert
  • Topics:

    1. Quality Culture for Data Integrity
    2. Regulatory Update - Diving into Data Integrity basic aspects
    3. Validation as continuous improvement

  • Special event information:

    A complimentary certificate of attendance will be available for all attendees, courtesy of our sponsor, Qualio.

Speaker

  • Galit Lisaey
    Galit Lisaey
    Data Integrity Consultant

    Galit Lisaey is a Data Integrity Consultant who helps organizations
    implement reliable, tailor-made, and accurate tools to meet Data
    Integrity standards.
    With 20 years of experience as Information Technology Project
    Manager and CSV Expert.
    Galit Lisaey established Gal.IT Data Integrity Consulting, out of the
    realization that many organizations lack the understanding of the
    need for Data Integrity support unit. The goal is to help them
    implement this activity through an in-house unit.

    The contents of her lectures and courses over the years contribute
    greatly to helping organizations to meet this requirement.

Qualio

Partner

Qualio
Website
https://qualio.com/

Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.

What people are saying

Àngels Llarch
Àngels LlarchPharmacist
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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
Read More
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.
Read More
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.
Read More
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
Read More
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.
Read More
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
Read More
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
Read More
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
Read More
Yan Kugel Alex Hall, thank you for the informative webinar. You did a nice job👏
Amritha Mukundan
Amritha MukundanQuality Control Professional
Read More
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
Read More
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.
Read More
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.
Previous
Next

Are You Ready To join us?

Event Registration

Local Time

  • Timezone: Asia/Singapore
  • Date: Oct 26 2022
  • Time: 22:00 - 23:30

Book Event

Available Tickets: Unlimited
The ticket is sold out. You can try another ticket or another date.
Total: 0

*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. 

Share This Event:

Leave a Reply

Your email address will not be published.

Get Informed About

Free Webinars &
Industry Insights

Subscribe to our newsletter