About This Course

Gain the skills and tools that have taken many experienced auditors decades to develop in this CQI and IRCA certified training GMP PQS Lead Auditor course (No 1773).

Learn how to perform better audits and have the opportunity to become a Certified GMP Pharmaceutical Quality Systems Lead Auditor. Designed and developed by ex-MHRA inspectors and industry experts, and taught by highly experienced pharmaceutical auditors and former regulatory agency inspectors, this intensive, five-day pharmaceutical lead auditor training course provides you the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control.

This course is designed for auditors assessing:

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

Built around personal practice, our curriculum follows the auditing guidance of ISO 19011, and includes a virtual audit of a facility that manufactures a range of dosage forms. You’ll plan and prepare audits of the supplier and your own supplier audit system with exercises in teamwork planning, preparation, performance and addressing who, why and how we audit. You’ll also be provided PQS and observations to find and classify, as well as the opportunity to practice an opening and close-out meeting. Further, delegates are assigned a personal tutor to address any questions they may have.

This course meets the training requirements for CQI and IRCA (www.quality.org) and is intended for individuals from a range of pharmaceutical backgrounds including QPs, quality assurance professionals, self-inspectors from QA and operations teams, virtual companies and quality unit staff. Many companies now require their auditors to be trained through the NSF certified lead auditor course.

Successful completion, along with the relevant experience, can lead to CQI and IRCA GMP PQS lead auditor certification. We have trained over 1,200 auditors with pass rates of 95 percent. This means you can trust our experts for your training. Although intense and challenging, delegates describe the course as “fantastic” and “worth it.”

Key Learning Objectives

This course provides auditors with the 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

Assessment

Teamwork and individual exercises are continuously assessed for the duration of the training course and there is a final exam. Should an auditor fail the exam, they will be offered the opportunity to retake it at no additional cost.

Who Should Attend

Delegates who attend should have working pharmaceutical GMP knowledge gained from, ideally, three to five years’ experience, or by having taken NSF’s GMP course. A team member will assess your level of experience prior to your attending the course.

Course Tutors

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

Course tutors will be selected from the following: