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
  • “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.” Duncan Mackenzie / Pharmasol
  • “Excellent course, materials and tutors. Surpassed my expectations. Thanks!” Barry Cook / Sanofi Aventis Pharma
  • “Extensive course notes and excellent lectures given by knowledgeable and professional tutors who were very easy to approach with any problems during the course.” Amjeid Saddique / Herd Mundy Richardson

An IRCA Certified Pharmaceutical PQS Auditor/Lead Auditor Course - Learn how to perform your best audit ever! And, have the opportunity to become a Certified Pharmaceutical PQS Auditor! This intensive 5 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

An IRCA Certified Pharmaceutical PQS Auditor/Lead Auditor Training Course No. A17638

Since its design, launch and certification in late 2011, this Pharmaceutical Quality System Lead Auditor course has trained over 200 delegates per year. The course has had fantastic delegate feedback.

This highly interactive course takes the form of a mock or virtual audit. It assumes experience and working knowledge of GMP guidelines in the region the auditor is working (EudraLex Volume 4 or US CFR 21), or previous attendance at an NSF Pharmaceutical GMP course.

  • The course follows ISO 19011 guidelines for quality and management systems auditing
  • The course is prepared using pharmaceutical industry standards including:
    • GMP
    • ICH Q8, 9, 10
    • PS 9000
    • ISO 9000

With special emphasis on the Pharmaceutical Quality System

Benefits and Key Learning Objectives

We all face increasing pressure to audit more with less, this course provides…

  • A toolkit of auditing skills designed by pharmaceutical auditing experts for Pharmaceutical Quality System Auditors covering:

    • How to develop into an even better auditor

    • How to structure, plan and manage your audits

    • How to develop your technical and non-technical skills

    • How to perform your best audit ever

  • Expert advice/experience and clinics for your auditing concerns

  • The GMP context for Pharmaceutical Quality System Lead Auditors

  • Tutors with credibility; they include former very highly regarded inspectors and Pharmaceutical Lead Auditors with a wealth of experience

  • Superb success rate for students

  • Unparalleled support and reference material for delegates

  • Personal assigned tutor to maximize your learning experience and exam opportunity

  • Essential guidance for auditors of suppliers, contractors, CMO, service providers, outsourced activities and self-inspectors

  • Essential education and development for QPs, those auditing on behalf of QPs and external and internal auditors wishing to improve

  • Essential training for those who need to demonstrate suitable experience and training to inspectors

  • Techniques for those who could face audits

  • An essential knowledge base for anyone wishing to improve Pharmaceutical Quality System audits

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

  • and many more

Concluding the Audit

  • Follow-up

Certification

This course meets the training requirements for the IRCA (www.irca.org) Certification of Pharmaceutical Quality Systems Auditor/ Lead Auditor (PQS).

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:

Other Dates and Venues for this Course

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

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