Why Personal Certification?

A Personal Certification through one of our programs gives objective evidence that the Certified individual has qualifications relevant for a certain role or job function.

With increased requirements on qualified individuals performing certain tasks within the Life Science industry, these programs gives both the certified individual and the regulated company an assurance that certain qualifications are fulfilled.

The qualifications for each role are clearly stated in a Requirement document and relates to both experience and knowledge.

The benefit of being Certified through one of our programs is that it gives assurance that the established requirements on both knowledge and experience for a defined certification are objectively fulfilled. After an initial certification, the program also evaluates that both experience and knowledge is maintained and increased over time.

   

Our Certifications

Below you will find a description for each of our certifications.
Click the buttons for full requirements.

Auditor / Lead Auditor
Pharmaceuticals or Medical Devices


Auditor
Personal certification as Auditor has been developed to ensure that the person being certified has relevant experience and knowledge about Auditing within respective area (Pharmaceutical or Medical Device). The requirements are related to Auditing in accordance with the standard ISO19011 and specifically applied to Pharmaceutical/Medical device audits as stipulated by regulatory requirements. As auditor, you are not expected to have experience from leading or coordinating an audit team. Both the experience and the knowledge required is specified in the Requirement document (ref). To maintain certification within the program, the person needs to show objective evidence of continued experience and training to stay current and updated when regulatory requirements change.

Lead Auditor
In addition to the required experience and competence for Auditor, a Lead Auditor shall have additional knowledge and competence to be able to lead and coordinate a team of auditors.

Next examination: Proctored online exam from January 2020

Language: English

Application form - Auditor / Lead Auditor (PDF) »
Re-certification form - Auditor / Lead Auditor (PDF) »

 

QA/RA Leader
Medical Devices


QA/RA
Personal certification as QA/RA Leader has been developed to ensure that the person being certified has at least the level of experience required in Article 15 in the upcoming EU Regulations for Medical Devices*/In-Vitro Diagnostics** to fulfil the role “person responsible for regulatory compliance” and in addition to this also give proof of knowledge in relevant areas for this role.

Both the experience and the knowledge required is specified in the Requirement document (ref). To maintain certification within the program, the person needs to show objective evidence of continued experience and training to stay current and updated when regulatory requirements change.

Next examination: Proctored online exam from January 2020

Language: English

Application form - QA/RA Leader (PDF) »
Re-certification form - QA/RA Leader (PDF) »

 

Examination

• Auditor / Lead Auditor - Pharmaceuticals or Medical Devices

• QA/RA Leader - Medical Devices

From the end of January 2020 the examinations will be performed on-demand with online proctoring by ProctorU.

ProctorU is a live online proctoring service that allows you to take your exam from the comfort of your home. ProctorU is available 24/7!

In order to use ProctorU you will need the following:

  • High-speed internet connection
  • Webcam (internal or external)
  • Windows or Mac Operating System
  • Up-to-date Chrome or Firefox browser and extension installed
  • Government issued photo ID

Note: Google Chromebooks and Tablets are NOT supported. ProctorU recommends that you visit https://test-it-out.proctoru.com/ prior to your proctoring session to test your equipment. We recommend you click on the button that says “connect to a live person” to fully test out your equipment. Please make sure that you are using the current version of your browser and have downloaded the ProctorU extension available here for Chrome and here for Firefox.
For the best proctoring experience, ProctorU recommends test-takers not use corporate network connections or Corporate laptops .

Stanley Willis

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Prices (excl. VAT)

Initial Certification: 530 Euro

Re-test: 400 Euro

Re-grade (From Auditor to Lead Auditor): 300 Euro

Re-certification (each fifth year): 300 Euro

Application

Download the application form below, complete and return to us by email.

» Auditor / Lead Auditor - Pharmaceuticals or Medical Devices

» QA/RA Leader - Medical Devices