Qualification of Warehouses & Large Cold Stores
Ensuring that the correct storage conditions are maintained for drug products and raw materials is essential in assuring that product/materials are not damaged (reduced efficacy and/or increased degradant levels) and shelf-life information is still applicable. Get it wrong, and it could have serious consequences for the patient. This course is aimed at ensuring attendees are equipped with knowledge that will help them meet industry standards and regulatory expectations in the area of qualification, including effective temperature mapping of warehouses and large cold stores. Ultimately, this will demonstrate the ability of the facilities to store all material within the desired conditions. The course includes: getting the requirements correct (URS for new/modified facilities); Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), including key stages for mapping, for example critical monitoring locations (including example monitoring location maps); instrumentation and reporting; and operational considerations (including the use of Mean Kinetic Temperature [MKT] for assessing the impact of deviations). The course is aimed at individuals involved directly or indirectly in qualifying these facilities. Target disciplines include validation, quality assurance, technical support, storage facility operation staff (supervisors and management), and engineering.
Presenter: Mike James
Thursday, 27th August 2020
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8:30 - 11:30 (London/Dublin)
9:30 - 12;30 (Amsterdam/Berlin)
Duration 3 hours
£300 per delegate
NOTE: Course fees will be subject to a 20% UK VAT charge if your billing/invoice address is in the UK and/or delegates are UK based