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IQC Expert Talk: “Latest update on the FDA’s Quality Management Systems Regulation” with Henning Carstens

(Aug 27 and Sep 05, 2024, online & free of charge & in English)

Register now!

 

The upcoming Quality Management Systems Regulation (QMSR) could bring significant changes to the current 21 CFR Part 820 Quality Systems Regulation. In our expert talk, we will address this topic and highlight the differences to ISO 13485. You will receive a comprehensive overview of all the new developments and practical tips for preparing for and effectively implementing the changes. Our team member Henning Carstens has valuable advice for you to make this transition smooth.


Online participation is of course free of charge.

Registration closed.

 

#IQC Group, #IQC Expert Talks, #QMSR, #21CFRpart820, #Validation

Info

IQC is an acronym for International Quality Consulting

IQC-Group is a global and independent consultancy that serves medical device manufacturers, pharmaceutical companies, medical device suppliers and biotechnology businesses.

In those branches lots of market leaders trust in IQC’s knowledge and consulting services.

IQC only employs highly skilled industry experts that have gained many years of practical experience in leading positions in pharmaceutical or medical devices companies. This is our guarantee to support your consulting project always with appropriate knowledge that can be transformed into your success immediately.

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satisfied clients

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successful projects

27 years

experience

Das ist IQC

Expert Seminars

Are you responsible for Quality Management, IT, business processes, product development or management? What are you waiting for?
IQC developed expert seminars based on our consulting experience, to offer the fastest access to the most important current trends in industry practice. Expert seminars are designed as 1- 2 day training courses.

IQC’s expert seminars comprise a theoretical introduction of the subject, that is followed by a precise course of action that meet your specific requirements. The seminar topics cover all hot areas from quality management, regulatory affairs, third party inspection preparation training to validation technology.
IQC’s expert seminars can take place either as an open seminar at central venues or as Inhouse-Event in your facility.

ISO 13485:2016

GMP / GLP / GDP

ISO 17025:2017

and other standards, directives and laws of the named sectors

Do you plan projects validation of processes, software or inspection methods?
We are happy to support you with the validation of:

Expertenseminare
Beratung
Über uns

We are experts with high passion

At IQC there is only one goal: Quality. Quality for people, quality for processes and quality for organizations. For us, quality is more than entitlement to our daily work. Quality is our promise, that we keep in second management generation already.

You are passionate to quality, as well? You are itching to realize fascinating projects as a member of IQC’s expert team? We like to get to know you – we are only one mouse-click away.

 

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GENERAL PRINCIPLE

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QUALITY is our passion

 

IQC’s founders decided quality to be the key to business success. IQC has been able to meet this demand during the past 26 years.


Those many customers that reached compliance with IOC’s help don’t lie.
Based on the continuous commitment to IQC’s core values and goals, kept by the experts team.


As the second-generation owners, we promise to keep all that for the future.
IQC stands for Quality for people, quality for processes and quality for the organizations.

 

 

 

IQC stands for quality for people, processes and organisations.

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Our Partners
Schrade & Partner Rechtsanwälte
Bayoomed Medical Software
RIMOC Information Management

Alle Personen, die im gleichen Prozess arbeiten, brauchen für ihre Arbeit stets die neuesten Produktdaten. Es geht darum, diese Komplexität zu beherrschen, Wissen und Ideen zu verknüpfen und gleichzeitig Daten sicher zu verteilen.
Diesen Prozessablauf zusammen mit Ihnen zu optimieren ist das Kerngeschäft von 
avasis

BAYOOMED ist die Medical Software Division der BAYOONET AG. Hier wird das medizinische Fach-know-how mit der Expertise unserer Softwareentwicklung kombiniert. Wir betreuen mehr als 500 Kunden aus dem Pharma- und Medizintechniksektor und sind spezialisiert auf die Entwicklung von medizinischer (Standalone)-Software und Medical Apps (iPhone, iPad, Android & Windows 8) gemäß IEC 62304, ISO 13485, ISO 14971 und EN 62366. 

How RIMOC makes the Difference - Information Management Competency

Successfully delivering answers for 20+ years in enterprise consulting based on a distinctive background in information management and technology, RIMOC consultants continue to help IT executives in domestic and international companies increase profitability through customized solutions, create better processes and bridge the gaps in information flow.

”In our judgment, the successful operation of a modern enterprise is best driven by an organizational structure whose primary responsibility focusses on optimization and control of information flow.”

SCHRADE & PARTNER Rechtsanwälte ist unser Partner in allen Fragen des Wirtschaftsrechts.

Von seinen Niederlassungen in Berlin und Baden-Württemberg aus berät SCHRADE & PARTNER Rechtsanwälte Mandanten in ganz Deutschland mit einem besonderen Schwerpunkt im  Recht des Gesundheitswesens.

Dominic Konrad, CEO

dominic.konrad@iqc-group.com

Mobile: +49 172 7640967

CONTACT US

IQC-Group AG

Beethovenstrasse 11

8002 Zurich

Switzerland

+41 44 500 90 90

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