Effective Pharmaceutical Audits and Self-Inspections

Monday, 03 November 2014
Effective Pharmaceutical Audits and Self-Inspections
Monday, 03 November 2014 08:30 -
Friday, 07 November 2014 13:00 (Central European Time)

Park Hotel Amsterdam
+31 20 671 1222
Stadhouderskade 25
1071 ZD

Map and Directions

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.

Faced with industry and regulatory pressure, NSF Health Sciences Pharma Biotech, was actively encouraged to successfully redesign an existing, popular course and reintroduce it with a new qualification for pharmaceutical Good Manufacturing Practices (GMP) lead auditors. The course, certified by IRCA (www.irca.org), the world’s largest international certification body for auditors of quality management systems, meets the training requirements of the 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 Health Sciences 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 (www.irca.org) Certification of Pharmaceutical Quality Management Systems Auditor/Lead Auditor (PQMS). IRCA course certification number: A17638

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.

Course Outline

  • The course 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-DBA 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 900
    • 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 programme 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

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put them into practice. Additionally, individually assigned tutors will provide delegates with an opportunity to obtain answers to their specific questions and concerns, providing maximum opportunity for success on the course.

The course includes an IRCA assessment exam. Our current pass rate is in the region of 95% +. Free support and re-sits are available within 12 months of the exam date for those few who may need the help.

Course Tutors

  • Mr Darren Jones
  • Mr Mike Halliday

The start and finish times given are approximate, please contact our office for further information.



Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility.

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.

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