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How to Audit - Chemical API Manufacture

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Improving Your Auditing Skills, The How To Audit Series

Dates: Thursday 21 to Friday 22 November 2013
Venue:
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
Cost:

£1400.00 excl VAT – £1680.00 inc VAT

Type:

About this course

Auditing of API manufacturers is receiving increasing scrutiny from European regulators primarily as a result of recent issues around counterfeiting of medicines such as the well-known Heparin scandal. In the European Union the responsibility for GMP conformity for the medicinal product lies with the Qualified Person of the holder of the marketing authorisation, and this includes GMP at the site of API manufacture.

From January 2013 the situation will become even more onerous for the MAA holder as the Qualified Person will then have to declare that they are satisfied with GMP controls within the whole of the supply chain, which includes the supply chain of the API manufacturer(s) used by that MAA holder.

European Union inspection bodies will therefore be placing even more scrutiny on the audits carried out for your companies to allow this declaration around the supply chain.

During this course we will discuss the standards used and the industry norms applied during the audit of API manufacturers. The aim of the course is to:

  • Improve your knowledge in the area of API auditing
  • Improve your skills in preparing for API audits
  • Increase confidence in conducting API audits
  • Understand how to report observations and respond to corrective action plans

We will also develop the tools you will need such as an audit plan and aide-mémoires to cover specific areas within that audit.

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If you do not find the course you are looking for please contact me at the NSF Health Sciences Kirkbymooorside Office

Bev Willett, Course Administrator, NSF Heath Sciences

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