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
  • “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

Learn how to perform your best audit ever! And, have the opportunity to become a Certified Pharmaceutical QMS 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 QMS Auditor/Lead Auditor Training Course No. A17638

This is the first truly independently certified pharmaceutical GMP auditor course available across Europe, and now globally. By the end of 2014 over 500 people attended this course making it one of our most popular and highest scoring public and in-house courses.

Pressure on the pharmaceutical industry to audit has never been higher and continues to increase. Supply chain decisions and batch release decisions are being made based on audits and self-inspections. As a result, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors.

Decisions are being made covering:

  • Approval of suppliers
  • Approval of contractors
  • Acceptability of in-house practices and procedures
  • Overall regulatory compliance status

Auditor skill and competency are critical to making the right decisions. This course will provide education, training and development for auditors to meet these continuing pressures and fulfil this critical role.

Who Should Attend

Anyone involved in the management and conduct of internal and external audits and self-inspections

Those who have to face auditors and want to be aware of the processes and techniques being applied

This will include:

  • Qualified Persons and Quality Assurance
  • Auditors old and new
  • Self-inspectors

What You Will Learn

  • The difference between an average auditor and a great auditor
  • How to structure, plan and manage an audit and self-inspection program or system
  • How to use and develop the auditor’s technical and non-technical skills, competencies and personal attributes to provide a toolkit of key auditing skills
  • Technical guidance through current hot topics from years of top level audit experience
  • Effective questioning techniques
  • Reviewing data
  • Techniques used to train inspectors from world renowned regulators
  • How to prepare for and conduct your best audit ever

Course Outline

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 four-day Pharmaceutical GMP course.

The course follows ISO 19011 guidelines for quality and management systems auditing

The course is prepared using pharmaceutical industry standards including:

  • ISO 9000
  • IPEC guides
  • PS 9000
  • GMP
  • Industry Standards of ICH with special emphasis on the Quality Management System and ICH Q10

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

Initiating, Preparing and Conducting the Audit

  • Materials management
  • Documentation systems
  • Sterile products
  • Oral solid dose
  • Packaging
  • Laboratories, and many more
  • Concluding the Audit: Wrap-up & Follow-up

Certification

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

Course Tutors

Learn from some of the most experienced auditors anywhere, each with a minimum of 30 years’ auditing experience. Both Darren and Liz are ex UK MHRA inspectors. Mike and David both have extensive auditing experience. Course tutors will be selected from the following:

Other Dates and Venues for this Course

16-20 March 2015 | Manchester
11-15 May 2015 | Manchester
21-25 September 2015 | York
2-6 November 2015 | Amsterdam

This Course Offers Enhancement for the Following Career Paths

  • Quality Management Systems
  • Audits/Self-Inspection

Register