Pharmaceutical Auditor Training

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

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.

NSF International worked with the Chartered Quality Institute (CQI) and the International Register of Certificated Auditors (IRCA, the world’s largest certification body for auditors of quality management systems) to develop the world’s first internationally recognized and certified course for pharmaceutical auditors that also meets the requirements of the U.S. FDA’s Q10 Pharmaceutical Quality System guidance.

As one of the most popular certified courses, we have trained over 1,000 auditors with pass rates of 95 percent, so you can trust our experts for your certified pharmaceutical lead auditor training.

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 verifying the detail of your own procedures and submissions.

We also provide other pharmaceutical auditor training throughout the year; check out our upcoming auditor courses and workshops below.

Pharmaceutical GMP Audits and Self-Inspections Course

This highly interactive course is designed to give you the skills and tools that have taken many experienced auditors decades to develop. It follows the auditing guidance of ISO 19011 and is a virtual audit of a manufacturing facility that makes a range of dosage forms and has its own pharmaceutical quality system. There are observations for you to find and classify, and you have the opportunity to practice an opening and close-out meeting.

Plan and prepare audits of the supplier and your own supplier audit system. The course is built around personal practice with exercises and teamwork in planning, preparation and performance, addressing who, why and how we audit.

With content and delivery of EudraLex Volume 4, Chapters 1 to 9, and ICH Q10 as the combined pharmaceutical quality management system (PQMS) included, students who attend the course and pass an exam can go on to become a CQI and 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

A Word From CQI and IRCA

Vincent Desmond, CEO of CQI and IRCA, speaks to the value of pharmaceutical 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.

CQI and IRCA-approved training organizations, such as NSF International, 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.”

Pharmaceutical Internal Auditor Training

NSF also offers pharmaceutical internal auditor training covering the essentials of internal audits, focussing on driving continuous improvement for your organization. This workshop forms an ideal starting point for those new to internal audits or as a refresher for experienced auditors.

You will learn:

  • About the organization and management of internal audit programs
  • Why it is still necessary to carry out internal audits
  • Tools and techniques to improve the effectiveness and confidence of the internal auditor

Our interactive auditor training is designed for individuals wishing to develop the essential skills necessary to perform effective departmental and system audits. It can be taken as a public course or we can customize and run it on-site.

The basic skills learned and practiced will enable you to conduct audits of any element of the pharmaceutical quality system and build on and improve your skills to eventually conduct full facility audits.

The natural progression from this workshop is our five-day Pharmaceutical GMP Audits and Self- Inspections training course to develop external auditing skills.

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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