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Effective Pharmaceutical Audits and Self-Inspection (An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course)


The First International Pharmaceutical QMS Auditor/Lead Auditor Certification

Dates: Monday 20 to Friday 24 May 2013
Manchester Marriott Victoria and Albert Hotel, Manchester, UK

£2600.00 excl. VAT – £3120.00 incl. VAT

Type: Pharmaceutical

About this course

In the last year alone we have seen further significant changes and additions to pharmaceutical legislation and guidelines that will all have a major impact on how we do business – these include:

  • FDASIA (Food and Drug Safety and Innovation Act) in the USA
  • Further enabling and clarification of the FMD (Falsified Medicines Directive) in Europe
  • Updated GMP guidelines that reflect the increasing impact and implementation of ICH Q10 (Pharmaceutical Quality System)
  • Draft guideline from the EC on GMP Risk Assessment for Excipients

And there will be more to come…

The success of your company in meeting current expectations will depend significantly on the quality of your audit and self-inspection system, and in the competence, professionalism and decision making of your auditors.

This is the first truly independently certified pharmaceutical GMP auditor course available across Europe, and now globally.

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.

The NSF-DBA ‘Effective Pharmaceutical Audits and Self-Inspections’ course is viewed by past delegates as one of our most favoured and successful courses.

Faced with industry and regulatory pressure, NSF-DBA was actively encouraged to successfully redesign an existing, popular course and reintroduce it with a new qualification for pharmaceutical group lead auditors. The course, certified by IRCA (, the world’s largest international certification body for auditors of quality management systems, meets the training requirements of the new Pharmaceutical Quality Management Systems Auditor/Lead Auditor course. This course has been specifically designed to provide delegates with education, training and development to meet today’s pharmaceutical pressures, including the auditor skills and toolbox of auditing techniques needed by the successful pharmaceutical lead auditor. Given the course focus, content and delivery of EudraLex Volume 4 Chapters 1 to 9 and ICH Q10 as the combined QMS, the team at NSF-DBA sees this as the first truly certified GMP auditor training course available globally today.

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 programme or system
  • How to use risk assessment to set audit priorities and rank observations
  • 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

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


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

The course is highly interactive and takes the form of a mock or virtual audit.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Quick links

NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Washington and Ann Arbor, USA

A word from NSF Health Sciences

If you do not find the course you are looking for please contact me at the NSF Health Sciences Kirkbymooorside Office

Bev Willett, Course Administrator, NSF Heath Sciences

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