How Quality Culture and a Mature QMS Are Linked

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.
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Date

Jul 19 2022

Time

CET Berlin
16:00 - 17:30

Local Time

  • Timezone: Europe/Amsterdam
  • Date: Jul 19 2022
  • Time: 16:00 - 17:30
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.

REGISTER

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

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