2021-10-26 2021-10-26 , Online Online, 1.090,- € zzgl. MwSt. Dr. Kirsten Plaßmann https://www.forum-institut.de/seminar/2110983-supplier-management-for-medical-devices/referenten/21/21_10/2110983-online-course-supplier-management-medical-devices_plassmann-kirsten.jpg Supplier Management for Medical Devices

An up-to-date overview of and insights into supplier management for medical devices and related activities: Find the right balance between compliance, costs and quality, and learn how to implement your own effective vendor management.

Your topics
  • Efficient processes, methods and interfaces in the design and monitoring of supply chains
  • Implementation of supplier audits
  • Review of existing purchasing processes
  • Current challenges for your purchasing department: Critical supplier
  • Legal, contractual and liability aspects
  • Budget control and KPI monitoring
Aims and objectives
Supplier management has become a priority for medical device and in-vitro diagnostics manufacturers since the revised ISO 13485:2016 standard was issued.

Due to the (EU) 2017/745 and 746 regulations, supplier management and vendor requirements have become even more stringent. In their audits, notified bodies are increasingly checking whether your supply chain meets the high quality requirements.

In this course, you will learn about all the current requirements as well as the essentials of supply and supplier management, both from a legal and practical perspective, including:
  • implementing QM systems at your suppliers;
  • contract clauses and negotiations;
  • liability risks due to defects in quality; and
  • conducting supplier audits.

Our experts will talk about the current requirements and suggest how to strike the right balance between regulatory compliance, costs and quality.
Who should attend

Are you responsible for the quality of medical devices or in vitro diagnostics, or for supply or vendor management?
Do you carry out or participate in supplier audits? Are you involved in purchasing and entering into contracts?
Do you take care of logistics processes in your company?

Then this course is designed just for you!

Supplier management for medical devices

Supplier Management
for Medical Devices

How you ensure the quality of your suppliers

Benefits
  • Have your questions answered
  • Online for your convenience
  • Practical, first-hand expertise
  • We comply the IMI quality criteria

Webcode 2110983

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

26.10.2021

26.10.2021

Zeitraum

08:30 - 09:00 Dial-in; 09:00 - 17:00...

08:30 - 09:00 Dial-in; 09:00 - 17:00 Course
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

An up-to-date overview of and insights into supplier management for medical devices and related activities: Find the right balance between compliance, costs and quality, and learn how to implement your own effective vendor management.

Your topics
  • Efficient processes, methods and interfaces in the design and monitoring of supply chains
  • Implementation of supplier audits
  • Review of existing purchasing processes
  • Current challenges for your purchasing department: Critical supplier
  • Legal, contractual and liability aspects
  • Budget control and KPI monitoring
Aims and objectives

Supplier management has become a priority for medical device and in-vitro diagnostics manufacturers since the revised ISO 13485:2016 standard was issued.

Due to the (EU) 2017/745 and 746 regulations, supplier management and vendor requirements have become even more stringent. In their audits, notified bodies are increasingly checking whether your supply chain meets the high quality requirements.

In this course, you will learn about all the current requirements as well as the essentials of supply and supplier management, both from a legal and practical perspective, including:

  • implementing QM systems at your suppliers;
  • contract clauses and negotiations;
  • liability risks due to defects in quality; and
  • conducting supplier audits.

Our experts will talk about the current requirements and suggest how to strike the right balance between regulatory compliance, costs and quality.

Who should attend

Are you responsible for the quality of medical devices or in vitro diagnostics, or for supply or vendor management?
Do you carry out or participate in supplier audits? Are you involved in purchasing and entering into contracts?
Do you take care of logistics processes in your company?

Then this course is designed just for you!

Detailed programme

08:30 - 09:00 Dial-in; 09:00 - 17:00 Course

09:15

Dr Kirsten Plaßmann

Legal framework
  • Requirements of applicable IMDRF-Documents, MDR (and MPDG) and consequences for practice
  • Good Distribution Practice (GDP)
  • OEM/PLM

09:45

Melanie Schoog

Supplier management requirements
  • MDSAP and ISO 13485:2016
  • ISO 19011
  • Guidance documents
  • Defining a critical supplier

10:45

Melanie Schoog

Supplier management in practice
  • Planning
  • Selecting potential supplier(s)
  • Supplier evaluation and acceptance
  • Defining the purchasing requirements
  • Monitoring and re-evaluating supplier performance and KPIs
  • Feedback and communication

13:15

Melanie Schoog

Second party audits - bringing value to supplier audits
  • Supplier audit programme, includingon-site and remote audits
  • Pre-audit Audit scope definition Supplier performance history Audit team
  • Audit Audit behaviour Closing meeting
  • Audit follow-up

14:15

Dr Kirsten Plaßmann

Contracts, recource and liability
  • Contracts and contractual requirements (framework supply agreements, quality assurance agreements)
  • Resource claims: When are they permissible? Liability scenarios

15:30

Melanie Schoog

Challenges of the purchasing organization
  • Supplier-customer relationship
  • Supplier, part and process changes
  • Supplier qualification vs part qualification
  • Working with design partners
  • Risk-based approach

Further information

Your benefits

This seminar will enable you to:

  • find and qualify the right supplier;
  • identify critical suppliers and set up measures to prevent bottlenecks;
  • carry out effective supplier audits;
  • keep track of the important elements of vendor contracts; and
  • maintain control of the budget and monitor key performance indicators (KPIs).

Course language

The course will be held in English: a good working knowledge is required.

Limited places

This course, like all other FORUM courses, is limited to 15 participants. This is in order to give participants the opportunity to thoroughly discuss the complex issues addressed in the programme. We recommend advance registration of at least 30 days.

How does an online course work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

This distinguishes our events

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Five stars on Trustpilot = Excellent

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