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
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, 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:
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.
The course is offered either virtually, or in-person. If you choose our virtual learning option, training will be delivered through a blended learning combination of self-paced learning and instructor-led virtual classrooms, catering to differing learning styles. Full details will be sent to you following registration.
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.”
This course provides auditors with the knowledge, skills and tools to:
Principles and Audit Planning
Auditor Skills and Competencies
Initiating, Preparing and Conducting the Audit
Concluding the Audit
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.
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.
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:
Discounts offered to NHS staff, and charities.
Whether you need to meet EU, FDA or other regulatory agency needs, this course provides the knowledge, skills and tools to succeed.
This course is designed to provide you with an overview of what is meant by data integrity and how to build a robust data governance system.
Our one-day course is ideal CPD for the pharmaceutical quality professional who wishes to refresh their knowledge of pharmaceutical law.