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

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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:

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

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

Speaker

Kathy Walsh GxP Specialist

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

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

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.