Investigating Out of Specification Results

Manchester, UK
Friday, 02 May 2014
Investigating Out of Specification Results
Friday, 02 May 2014 08:30 - 17:00 (GMT)

Manchester Marriott Victoria and Albert Hotel
Water Street
+44 (0) 161 832 1188
M3 4JQ
United Kingdom

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Price: £735.00 (excl VAT-discounts may be available). 

The way a company responds to Out of Specification (OOS) results is a key part of GCLP, which first came to prominence in 1993, following the Barr case. The US FDA first issued draft Guidance for Industry on handling OOS results in 1998.

In October 2006 the final version of the FDA OOS Guidance was published. In late 2010, the UK MHRA published the first Guidance on this subject by a European authority. This pharmaceutical training course will compare the US and UK Guidance.

The adequacy of the investigations that should take place following the generation of an OOS result and the release/reject decision that must subsequently be made, is seen as a key measure of the overall integrity and probity of a pharmaceutical company.

This pharmaceutical training course is designed to provide you with practical advice on how to investigate OOS results and make appropriate decisions, which will meet Regulatory expectations and add real value to your business.

The recent quality system guidance, such as ICH Q10 and the FDA Process Validation, means that inspectors are now focusing much more on trend analysis.

Every company will inevitably generate OOS and Out of Trend (OOT) results at some time, so this is an area of GMP compliance that cannot be ignored.

What You Will Learn

  • The Barr case history
  • What the October 2006 FDA OOS Guidance says and what it means
  • What the 2010 MHRA Guidance says and what it means
  • How to assess the quality of the data generated by your laboratory
  • The relationships between OOS, OOT and other atypical results
  • How to identify OOT stability results
  • How to conduct effective OOS and OOT investigations and interpret the results
  • What to consider when making batch release decisions

Course Outline

OOS and OOT results

  • The Barr Case
  • FDA’s October 2006 Guidance for Industry and 2010 MHRA Guidance on OOS results:
    • Scope
    • Laboratory investigations
    • ‘Full-scale’ investigations
    • Re-testing and re-sampling
    • Reporting of results
    • Concluding investigations
Assessing the quality of laboratory data; identifying OOT and atypical results

Practical guidance on conducting laboratory investigations

The making of batch release decisions following OOS and OOT investigations

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 theory into practice. Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Best Practice for the Analytical Laboratory

The integrity of analytical laboratory data relies on the knowledge, understanding and training of all the people involved

Over the past 25 years we have built a strong reputation for providing high quality training on numerous aspects of Good Manufacturing Practice.

This course is designed to provide you with our ‘trademark’ practical advice on what to do to achieve cost-effective quality assurance whilst satisfying current regulatory authority expectations.

Course Tutors

  • Mr Peter Gough

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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