How to Audit - QC Chemical Laboratories

Manchester, UK
Wednesday, 30 April 2014
How to Audit - QC Chemical Laboratories
Wednesday, 30 April 2014 08:30 -
Thursday, 01 May 2014 17:00 (GMT)

Manchester Marriott Victoria and Albert Hotel
UK,HS,BIO,AS,QC,CR,qcc
Water Street
+44 (0) 161 832 1188
Manchester
UK
M3 4JQ
United Kingdom

Map and Directions

        

Price: £1,470.00 (excl VAT-discounts may be available). 

This pharmaceutical training course is designed to provide existing auditors with the necessary technical detail to enable them to effectively audit a Quality Control (QC) chemical laboratory to ensure that both EU and FDA GMP requirements are met. It is ideal for delegates who have either previously attended NSF-DBA’s IRCA certified Pharmaceutical Quality Management Systems Auditor/Lead Auditor course or who already have a good understanding of the basic principles and practices of auditing and wish to expand their technical understanding of good QC laboratory practice. The course can also contribute to registered Auditors’ and Lead Auditors’ professional requirement for continued professional development (CPD).

This pharmaceutical training course will also be ideal for personnel who work within a QC chemical laboratory and who wish to learn how to conduct comprehensive self-inspections.

What You Will Learn

  • Why it is important to audit QC laboratories
  • How to plan QC laboratory audits
  • The critical areas to focus on during the audit of a QC laboratory
  • How to classify QC laboratory audit observations
  • To develop an audit aide-mémoire for auditing QC laboratories

Course Outline

  • Auditing QC laboratory quality systems
  • Laboratory audit planning
  • Auditing laboratory documentation
  • Requirements for sampling and sample management
  • Premises and equipment expectations
  • Classifying QC laboratory audit observations
  • Auditing analytical method validation and transfer
  • Auditing chromatography
  • Auditing OOS and OOT procedures
  • Developing a QC laboratory audit aide-mémoire

Why not bring your problems for discussion?

The course offers an ideal opportunity to speak to experienced tutors and to delegates who are in similar roles.

Our courses are planned to inform you and also to enable you to gain answers to your specific queries via debate, group work sessions and a panel discussion.

Course Tutors

  • Mr Peter Gough
  • Mrs Oona McPolin

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. Please note that if using this method a 2.5% service charge will be added to the total amount. The total purchase price (including VAT if applicable) and service charge will be displayed prior to confirming the order.

    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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