Pharmaceutical GMP Audits and Self-Inspections (A CQI and IRCA Certified Training GMP PQS Lead Auditor 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, 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. Youll 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. Youll 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.
Upcoming start dates
Enquire for more information
- Virtual Classroom
Suitability - Who should attend?
Delegates who attend should have working pharmaceutical GMP knowledge gained from, ideally, three to five years experience, or by having taken NSFs GMP course. A team member will assess your level of experience prior to your attending the course.
Outcome / Qualification etc.
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
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
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.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Average rating 5
It was an excellent training with experienced and knowledgeable trainers. I will definitely use in practice from what I have learned this week.
Intense and challenging but brilliant. Very interactive and set at a level for all levels of experience. Presented extremely well with very knowledgeable tutors.
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.
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.