« Medical/Hospitals

GMP for Blood Banks


Date Venue Days
Of Your ChoosingIn-House0.5Enquire

GMP for Blood Banks 

Half Day Training Course

Background

 

European Union Directive 2002/98/EC states in recital 16 that Blood establishments should establish & maintain quality systems involving all activities that determine the quality policy, objectives & responsibilities & implement them by such means as quality planning, quality control, quality assurance & quality improvements taking into account the principles of GMP.

 

This half day programme looks at the requirements for GMP which must be followed by the Pharmaceutical manufacturer & relates these to ISO 15189, the Quality Management Standard required in Blood Banks.

Learning Outcomes

 

On successful completion of this training course, delegates should be able to:

  • Understand the terminology used by the EU Pharmaceutical manufacturer
  • Compare the clauses of ISO15189 with the EU GMP requirements
  • Understand the Blood Directive Quality Management System requirements 

Who Should Attend

 

Medical Laboratory & Haemovigilance staff involved in Blood Banks. 

Course Programme

 

  • Introduction to Quality Management Systems & relationship of ISO 15189 clauses with EU GMP chapters.
  • Minimum requirements for compliance with Article 14 & 15 of Blood Directives.
  • Blood Directives overview. 

Course Times

9.00am - 1.00pm

In-House Courses

For In-House courses, the tutor will contact you in advance to discuss the course programme in more detail in order to tailor it specifically for your organisation.

Course Manual

Delegates will receive a very comprehensive course manual.

This course is available exclusively on an In-House basis.

Rev 3