Electronic Records And Signatures Computer Validation Quality Management Systems Purified and WFI Systems Training and Coaching Feedback and Contact
 

TRAINING AND COACHING

   Vulcanbury Ltd. training and coaching enable organisations to develop in house expertise to maintain operational regulatory compliance.

   The following courses can be delivered at an individual - small group level or alternatively delivered on a larger scale to departments and organisations in conjunction with Vulcanbury's supporting partner RSSL Pharma.

Computer Validation
  Covering the key aspects of the validation lifecycle in accordance with GAMP4 and regulatory requirements. Course includes Validation Planning, Design activities, Build / Review, Testing and Implementation.

Electronic Records and Signatures
  Covering the key aspects of the FDA ruling 21CFR Part 11. Course includes identification of GMP data, Open and Closed system requirements, case studies of various systems.

Legacy System Validation
  Covering the key aspects of how to approach legacy system re validation. Course includes strategic approach to systems, risk analysis, collation of historical evidence, focussed validation activities.

Reducing Validation Costs
  Covering the key aspects of how to reduce validation costs. Course includes batch v's jobbing approaches, use of templates, stakeholder involvement, document management.

Purified and WFI Systems
  Covering the key aspects of water generation, storage and distribution. Course includes practical experience in best practice and design.

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