Lead Auditor - Medical Devices (optional QP Module 11)

Monday, 29 September 2014
Lead Auditor - Medical Devices (optional QP Module 11)
Monday, 29 September 2014 08:30 -
Friday, 03 October 2014 17:00 (GMT)

Hilton London Olympia
UK, HS, MD, M11, CR
+44 (0)207 603 3333
380 Kensington High Street
W14 8NL
United Kingdom

Map and Directions

Medical device auditing is a specialist skill requiring a high degree of technical/process knowledge and a thorough understanding of medical device legislation, product and process specific standards, process validation, good manufacturing practices and risk management. This 5 day course is the first to combine all these aspects and provide you with the technical grounding to undertake assessments of your organisational internal processes, the supply chain and third party audits.

The course introduces the Global Harmonisation taskforce requirements for regulatory auditing as well as the US FDA Quality System inspection strategies and combines requirements within the medical device regulations (93/42/EEC, 90/385EEC and 98/79EEC, ISO 14971, ISO14155, post market surveillance and vigilance) as well as enabling you to interpret the requirements of the major regulatory GMP requirements (ISO13485:2003, CFR21 Part 820, Ordinance 169 and the CMDCAS requirement guidance in GD210). It takes you through the medical device regulations, principles of design, validation and risk management, as well as introducing you to some of the most common features of Third Party auditing in medical device organisations.

The course is fast paced, heavily workshop driven, intense and thorough, as it is used as a basis of demonstrating that you have achieved the necessary competence to lead audit teams and make key decisions associated with medical device regulation (Third Party approval, supply chain approval or
due diligence assessment)

This is a unique course brought to you by the most respected notified body auditors in the world. It is designed to address the fundamental failure of similar courses to provide third party auditors with the confidence to make regulatory decisions relating to medical device organisations.

Course Outline

  • Key European medical device regulatory requirements, including clinical benefit, essential safety and performance requirements, common technical specification and harmonised
  • standards
  • How design control, risk management, validation, clinical evaluation, post market surveillance and the quality management system work together to demonstrate safety and efficacy
  • Auditing strategies adopted by the key European medical device notified bodies and FDA Compliance team
  • ISO 19011 and its impact on you as a lead auditor and auditing strategies from both the US quality system inspection technique and the condensed internationally harmonised GHTF
  • study group 4 guidance
  • An appreciation of all process requirements and interactions involved in the product lifecycle – A complete medical device product lifecycle sub-system approach.
  • Typical assessment methods and non-conformities that affect assessment decisions for third
  • party certification or supplier approval
  • How to assess critical processes such as design, risk management, validation, post market surveillance, vigilance and regulatory processes, manufacturing control, supplier control, document control and change control

Course Tutors

  • James Pink
  • Henry Sibun

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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