Pharmaceutical GMP Audits and Self-Inspections

NSF International, Pharmaceutical Services
Course summary
5 days
3,130 GBP excl. VAT
Open / Scheduled
Next available date: 29/06/2020 08:30 - Oxford
Course Dates
29/06/2020 08:30 
3,130 GBP
14/09/2020 08:30 
3,130 GBP
02/11/2020 08:30 
3,130 GBP

Course description

Pharmaceutical GMP Audits and Self-Inspections (A CQI and IRCA Certified Training GMP PQS Lead Auditor Course)

NSF’s five-day lead auditor training course is designed and developed by ex-MHRA inspectors and industry experts. 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 lead auditor training.

The course provides extensive practical support and training for the pharmaceutical auditor, including a practiced toolkit of skills. This course meets the training requirements for CQI and IRCA. Successful completion, along with the relevant experience, can lead to you becoming a certified CQI and IRCA GMP PQS lead auditor.

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 which makes a range of dosage forms, with its own PQS and observations for you to find and classify, along with 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 teamworks in planning, preparation and performance, addressing who, why and how we audit.

Although this is an intense and challenging course, participants describe it as “fantastic” and “worth it”. You will be supported by a personally assigned tutor to answer any questions you may have.

This course is designed for auditors assessing:

  • Manufacturing operations
  • Contract manufacturing organizations
  • API suppliers
  • Excipient suppliers
  • Packing component suppliers
  • Service providers

And aimed at individuals from a range of pharmaceutical - backgrounds; including QPs, quality assurance, self-inspectors from QA and operations teams, virtual companies and quality unit staff.

Many companies require their auditors to be trained through the NSF certified lead auditor course.

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

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Get in touch on this page to find out whether there are any changes to this course in light of COVID-19.

Suitability - Who should attend?

You should have a working pharmaceutical GMP knowledge gained from ideally three to five years of experience or from NSF’s GMP course and there will be a final exam.

The course team will support you before you attend the course to confirm your prior knowledge.

Training Course Content

Principles and Audit Planning

  • Planning and preparation
  • Audit types and techniques
  • Establishing an audit program for suppliers, contractors and company sites
  • Internal vs. external audits
  • The audit process

Auditor Skills and Competencies

  • What makes a good auditor
  • Communication skills – questioning and listening
  • Body language and non-verbal communication
  • Overcoming apathy, resistance and aggression
  • Effective note taking
  • Auditor continuing professional development
  • Assessing the auditor
  • Managing auditors

Initiating, Preparing and Conducting the Audit

  • Materials management
  • Documentation systems
  • Pharmaceutical quality systems
  • Sterile products
  • Oral solid dose
  • Packaging and many more

Concluding the Audit

  • Wrap-up
  • Follow-up


Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

Providing You with Solutions Across the Product Life Cycle NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York


Average rating 5

Based on 3 reviews

Jan Bernaards
It was an excellent training with experienced and knowledgeable trainers. I will definitely use in practice from what I have learned this week.
Kate Waterhouse, Napp Pharmaceuticals, UK
Intense and challenging but brilliant. Very interactive and set at a level for all levels of experience. Presented extremely well with very knowledgeable tutors.
Duncan Mackenzie / Pharmasol
I walk away from the course with immense confidence in how to approach my next audit and furnished with lots of continuous improvements for my company's audit system.
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