Course Overview

  • “Intense and challenging but brilliant. Very interactive and set at a level for all levels of experience. Presented extremely well with very knowledgeable tutors.” Kate Waterhouse / Napp Pharmaceuticals, UK
  • “Very enjoyable and useful course with varied and interesting training techniques.” Jonathan Austwick / Smith & Nephew, UK
  • “An intense course which will provide the learning to provide high quality audit reports, consistently. An amazing mix of experience, really learned from colleagues as well. A great course, recommend for any auditor or quality professional who may unAnthony Pinney / Creo Pharma, UK
  • “Fantastic course, good pace and mix of presentation and group sessions.” Clare Hargreaves / Seqirus, UK
  • “Thought the trainers were fantastic. It's nice to see some people who are genuinely interested in increasing my capability. Hand on heart I learnt a lot more than I imagined I would over the last few days.” Daniel Sicklen / Procter and Gamble, UK

Learn how to perform your best audit ever! And, have the opportunity to become a Certified GMP Pharmaceutical Quality Systems Lead Auditor! This intensive five-day course, taught by highly experienced pharmaceutical auditors and former regulatory agency inspectors, will provide you with the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the auditees.

About This Course

A CQI and IRCA Certified Training GMP PQS Lead Auditor Course! Course no. 1773

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 (www.quality.org). 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, delegates 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.

Key Learning Objectives

Provide auditors with knowledge, skills and tools to:

  • Understand the GMP context for pharmaceutical quality system lead auditors
  • Plan, conduct, report and follow-up an audit of a GMP PQS
  • Provide guidance for auditors of suppliers, contractors, CMO service providers, outsourced activities and self-inspectors
  • Develop QPs and those auditing on behalf of QPs
  • Drive continuous improvement of systems and processes
  • Drive continuous improvement of auditors and audit systems

Course Outline

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 

What Experience Do You Need To 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.

Assessment

You will be continually assessed for the duration of the training during teamwork and individual exercises, supported by a personally assigned tutor.

The final exam is designed to be challenging, but pass rates have been 95 percent. Should an auditor fail the exam, he/she will be offered a free-of-charge opportunity to retake the exam at an agreed date and venue.

Course Tutors

Learn from some of the most experienced auditors in the industry. Each has completed hundreds of pharmaceutical GMP audits and has decades of experience in the industry as MHRA inspectors, auditors and auditor team managers.

Course tutors will be selected from the following:

Course Fees

Course cost (excluding VAT)  £2,970.00

DISCOUNTS AVAILABLE
Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details

Have a question or want to book a place? Contact ASIpharma@nsf.org - you can also register online by clicking below.

Other Dates and Venues for This Course

For other dates and venues for this course, visit our course calendar

Register