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: January 25, 2019, Copenhagen, Denmark

Languages: English and Swedish

Download Application 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: January 25, 2019, Copenhagen, Denmark

Languages: English and Swedish

Download Application form - QA/RA Leader (PDF) »

 

Next examination

Our planned examination occations

• Auditor / Lead Auditor - Pharmaceuticals or Medical Devices

• QA/RA Leader - Medical Devices

Stanley Willis

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45mins

Saloon A

Beginner

About 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 minimum 30 days before the examination.

» Auditor / Lead Auditor - Pharmaceuticals or Medical Devices   Jan 25, 2019, Copenhagen

» QA/RA Leader - Medical Devices   Jan 25, 2019, Copenhagen