Pharmaceutical Auditor Training

  • Overview
  • Pharmaceutical GMP Audits and Self-Inspections
  • A Word From IRCA
Pharmaceutical Auditor Training

NSF International worked with the International Register of Certificated Auditors (IRCA) to develop the world’s first internationally recognized and certified course for pharmaceutical auditors: Pharmaceutical GMP Audits and Self-Inspections.

The course is designed to address an ever-growing need to audit not only your own operations but those of your suppliers and service providers to ensure compliance with diverse international Good Manufacturing Practice (GMP) and regulatory requirements, as well as ensuring the detail of your own procedures and submissions.

The course is based on GMP and auditing the pharmaceutical quality management system, and has become hugely popular with pharmaceutical companies all over the world.

Other auditor related courses are run throughout the year and the list of upcoming courses can be found below.

Pharmaceutical GMP Audits and Self-Inspections

In response to the scrutiny being placed on the training and development of internal auditors, external auditors and self-inspectors, NSF created a course for pharmaceutical lead auditors that provides the education, training and development needed to meet today’s pharmaceutical pressures: Pharmaceutical GMP Audits and Self-Inspections.

This is the world’s first internationally recognized and certified course for pharmaceutical auditors and includes auditor skills and a toolbox of auditing techniques.

The course is certified by the International Register of Certificated Auditors (IRCA), the world’s largest certification body for auditors of quality management systems (QMS), and meets the requirements of the U.S. FDA’s Pharmaceutical Quality System.

With content and delivery of EudraLex Volume 4, Chapters 1 to 9, and ICH Q10 as the combined QMS, this is the first truly certified good manufacturing practice (GMP) auditor training course available globally today.

Students who attend the course and pass a short test can go on to become an IRCA certified pharmaceutical auditor by providing evidence of their practical auditing skills through submission of audit logs.

The success of your company in meeting current pharmaceutical legislation and guidelines depends significantly on the quality of your audit and self-inspection system, and in the competence, professionalism and decision making of your auditors.

The course provides the education, training and development needed to meet today’s pharmaceutical pressures and covers:

  • The difference between an average and a great auditor
  • How to structure, plan and manage an audit and self-inspection program or system
  • How to use risk assessment to set audit priorities and rank observations
  • How to use and develop the auditor’s technical and non-technical skills, competencies and personal attributes to provide a toolkit of key auditing skills
  • Technical guidance through current hot topics from years of top-level audit experience
  • Effective questioning techniques
  • How to review data
  • How to prepare for and conduct your best audit ever

The course is highly interactive and takes the form of a virtual audit. Discussion periods, including a course instructor panel session, provide attendees an opportunity to obtain answers to their specific questions and concerns.

The course Pharmaceutical GMP now forms an entry-level GMP training requirement for our very popular Pharmaceutical Quality Management Systems Auditor/Lead Auditor Training Program.

A Word From IRCA

Vincent Desmond, Deputy Director of the International Register of Certificated Auditors (IRCA), speaks to the value of auditor training:

“Quality management systems auditing is a professional activity and, as with any profession, requires individuals to have the necessary knowledge and skills, and to deploy the required behaviors to deliver value:

  • Value for the stakeholders who rely on management systems audits to establish if the organization has the capability to consistently meet customer and applicable regulatory requirements
  • Value for the auditee by providing management with information regarding the organization’s ability to meet its quality-related business objectives, by identifying problems that may prevent the client from meeting its quality-related business objectives and by identifying meaningful opportunities for improvement and areas of risk that are not identified or managed.

IRCA-approved training organizations, such as NSF Health Sciences, play a key role in setting auditors off on their journey to delivering this value by providing training and examination against international audit and quality management standards.

Post training, IRCA PQMS lead auditor certification provides the professional framework for auditors to gain audit experience, working within a professional code of conduct and committing to ongoing maintenance and development of their knowledge and skills. Developing a cadre of professional PQMS lead auditors will help ultimately support confidence that our sector is dealing with the industry changes and increasing regulatory pressures.”

Upcoming Courses & Webinars

In Pharmaceutical Auditor Training
  • “I have learned a lot, and the book was informative. I will apply this in my work situation.”Godfrey Radebe / Johnson & Johnson Medical, SA
  • “Course materials were extensive. Tutors were very open and extremely knowledgeable.”Maliga Chetty / Adcock Ingram Healthcare
  • “The course helped me understand how to conduct myself in an audit and the key elements of auditing. I am now able to gain insight into auditors who will audit me.”Ursila Singh / Resmed Healthcare
  • “Excellent content and organization. Good mixture of lectures, activity sessions and sharing of real life experiences. Very useful role play sessions.”Sue Marlow / Patheon Pharmaceutical Services, UK
  • “One of the best training courses I have ever been to! The mix of lectures, teamwork and presentations was very good and gave a lot of opportunities to practice and discuss with other participants. Very competent trainers.”Kicki Garhedenn / Fredriksson, Octapharma AB
  • “I would strongly recommend this course to anyone who performs pharmaceutical compliance auditing, from novices to experienced professionals. I was impressed with the instructors; their presentation and interpersonal skills were especially good.” Paul J. Siciliano / Patheon Pharmaceutical Services, USA
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