How Quality Culture and a Mature QMS Are Linked

Time

CET Berlin
16:00 - 17:30

Date

Jul 19 2022
Expired!

Learning Type

Free Live Webinar

Overview

A healthy QMS is the backbone of any company working in a regulated environment. Unfortunately, many companies sabotage their compliance through a lousy culture.

If you answer yes to one or more of these questions, it could signify that your Quality Culture is suffering or just plain dysfunctional:

  • Is there a disconnect between leadership decisions and trying to meet quality requirements?
  • Do you struggle to influence others to be consistently compliant, or do personnel revert to default ways of working?
  • Is your company training program ineffective at impacting company compliance culture?

You will always struggle to have a mature QMS when the culture does not complement compliance, which can cause your QMS to be more of a liability to your company than an asset!

No one likes being told what to do, so making compliance a rule is not necessarily the best way. Unfortunately, that is essentially the track that many companies take towards compliance. And there will always be those in a company looking to ‘dodge and weave’ their way around quality. So, what can we do?

To solve the problem, you need to understand the link between a traditional QMS – processes, product, procedures, records, etc. – and culture, especially the ‘people piece.’

In this webinar, Kathy Walsh will shed light on the following topics:

  1. Is there a link between quality culture and a mature QMS?
  2. Quality Management Maturity (QMM) and quality culture.
  3. Keys to shifting towards a more robust quality culture.
  4. Creating Quality Culture objectives.
  5. Take quick action where you are.

After the webinar, you will know what is required to establish or maintain a well-functional QMS.

  • Who Should Attend:

    Quality professionals, Operations, Senior leadership, consultants

  • Skill Level: Intermediate , Expert
  • Topics:
    1. Compliance vs. Culture
    2. Is there a link between quality culture and a mature QMS?
    3. Quality Management Maturity (QMM) Keys to shifting towards a more robust quality culture
    4. Taking action – moving the dial!
    5. Conclusions and Q&A.

Speaker

  • Kathy Walsh
    Kathy Walsh
    GxP Specialist

    Kathy helps companies, startups, and individuals in regulated
    industries design & implement quality compliance solutions that
    increase productivity and master the quality challenges in their
    marketplace.
    Kathy has over 20 years of experience working in the
    pharmaceutical, medical device, distribution & wholesaling,
    secondary packaging, compounding, biotech, Medtech, and R&D.
    She specializes in helping clients achieve their compliance and
    accreditation to regulatory requirements, particularly:
    • Pharmaceuticals – Good Manufacturing Practices (GMPs) with
    various regulators
    • Medical devices – ISO13485 and ISO14971
    • Calibration and testing laboratories – ISO 17025
    • Medical laboratories – ISO 15189
    • Cosmetics – ISO 22716
    • Quality Management Systems (general) – ISO9001.
    Kathy is passionate about helping companies and individuals
    adopt Plain Language writing to increase productivity and
    compliance, and reduce documentation issues, confusion and
    user errors. She is a published author on applying Plain Language
    to GxP documentation.
    In addition to her scientific qualifications (Ph.D.), Kathy is a
    qualified project manager, trainer, and technical writer. Kathy is
    the Director of QSN and runs the QSN training program via QSN
    Academy

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.

Additional Partners

Quality Systems Now
Quality Systems Now
Website
https://www.qualitysystemsnow.com.au/

Quality Systems Now works with organizations to implement structured and clear QMS, support their accreditation or commercialization, or provide help with GxP compliance projects.

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
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
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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.
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.
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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
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
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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
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.
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Local Time

  • Timezone: America/New_York
  • Date: Jul 19 2022
  • Time: 10:00 - 11:30

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