GMP PQS Lead Auditor (CQI & IRCA Certified Training)

What you'll gain from this course

Hands-on exercises and real-world application

Engaging group discussions and activities

Networking with peers and trainers

Gain the skills and tools that many experienced auditors take decades to develop in this CQI and IRCA certified GMP PQS Lead Auditor course.

Learn how to perform more effective audits and work toward becoming a Certified GMP Pharmaceutical Quality Systems Lead Auditor. Designed by ex‑MHRA inspectors and industry experts, and taught by highly experienced auditors and former regulatory inspectors, this intensive course gives you the knowledge, skills and confidence to audit all aspects of pharmaceutical manufacture and control.

This course is designed for auditors assessing:

Manufacturing operations
Contract manufacturers
API suppliers
Excipient suppliers
Packing component suppliers
Service providers

Built around practical application, the curriculum follows ISO 19011 and includes a virtual audit of a facility manufacturing multiple dosage forms. You will plan and prepare audits of suppliers and your own audit system, with exercises in planning, preparation, performance and audit rationale. You will review PQS examples and observations, and practise opening and close‑out meetings. Each delegate is also assigned a personal tutor.

This course meets CQI and IRCA (www.quality.org) training requirements and is suitable for QPs, QA professionals, self‑inspectors, virtual companies and quality unit staff.

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 15hrs self-paced learning and 25 hrs 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 1,800 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.”

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.

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:

Darren Jones
Samantha Clack
Marie O’Callaghan
Tony Mayhall
Phil Rose

Discounts

NHS staff will receive an automatic discount when registering with an NHS email address.

Learning Outcomes

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

Who Should Attend

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

This course is designed for professionals who need practical auditing skills for GMP compliance. It’s ideal for internal and supplier auditors, quality assurance teams, and those managing Quality Management Systems.