Requirements
Who is the personal certification as auditor for?
Personal certification as Auditor has been developed to ensure that the person being certified has relevant experience and knowledge about Auditing within respective area (GMP/QMS requirements Pharmaceutical or Medical Device).
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 at a time planned to suit your needs.
Language: English
Lead Auditor
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.