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QMS Lead Auditor for the Pharmaceutical Industry

Course code

40 hours


This course provides comprehensive certification for Auditors in the Pharmaceutical industry.

Certified by CQI and IRCA and the Pharmaceutical Quality Group (PQG), this Lead Auditor course has been specifically developed for the pharmaceutical industry.

The course incorporates the principles of performing first, second and third-party audit as an Auditor/Lead Auditor to the supply chain of pharmaceutical manufacture. In the absence of having mandatory GMP this course is intended for individuals to acquire the knowledge and skills to lead audits of suppliers to both GMP and non-GMP utilising PS9000, EXCiPACT, IPEC, ISO 15378, and ISO 9001 in accordance with ISO 19011, ISO 17021-1, as applicable.

This course includes two examinations:

CQI and IRCA 2-hour written exam

PS9000 1-hour Certification exam

Who is it for?

This course is for those intending to acquire the understand and competence of how to apply the appropriate standards either as a third or second-party auditor for auditing pharmaceutical suppliers:

  • PS9000 for packaging components
  • EXCiPACT and IPEC/PQG GMP for Excipients
  • EU GMP Part II for APIs, ISO 15378 for primary packaging components

Successful completion of this course provides learners with a qualification in auditing that is recognised by the PQG.  Successful completion of this course also meets the training requirement for certification as an auditor on IRCA's PQMS Auditor Certification scheme.

Recommended Prior Knowledge

FD116: QMS ISO 9001:2015 Foundation

Knowledge of  ISO 9001, ISO 15378, PS9000, IPEC and EXCiPACT standards is desirable prior to the course. It is also desirable you have some knowledge in the following areas: Quality Management Systems and the core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continuous improvement. The quality management principles (see ISO 9000) are also desirable and the relationship between quality management and customer satisfaction and ISO 9001.

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