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 The US FDA first issued draft Guidance for Industry on handling OOS results in 1998.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.
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.
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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.