Process Validation

Process Validation is a core activity for manufacturing organisations requiring an accurate and reliable level of compliance for their products.



Industries such as the Medical and Pharmaceutical, Defence, Food, Auto and Aerospace Engineering benefit from this practical, statistical approach for ensuring compliant product.

The training is targeted at any member of the organisation who would be involved in creating  product, such as the Production Staff and Operatives, Quality Team, Line Managers and Team Leaders, Project Leaders, Engineers and Maintenance Teams.

Aim of the Course
 
The aim of the training course is to demonstrate how to implement Installation, Operational,  Process and Validation Qualifications for a manufacturing activity and provide the underpinning knowledge to successfully apply this to your processes.
 

Training Course Content
  • Practically demonstrate an IQ/OQ/ PQ/VQ in a manufacturing environment and explain the benefits.
  • To gain an understanding of the importance of process validation and have a process example to follow for future validation activities.
  • Identify what and when to validate.
  • Reinforce good validation practices in line with customer and compliance expectations.
  • To provide a common validation language across all members of the workforce.

Case Study - Surgical Innovations Limited

Surgical Innovations provides medical devices globally to surgeons and hospitals. As part of a continuing operation to bring all engineering processes in-house, Surgical Innovations has ventured into the area of injection moulding. In order to have the whole new production area installed and running, alongside the company's continued expansion in other areas, more than 30 staff were needed to be trained and updated in Process Validation procedures. Qualitrain were contacted to provide this service.
 
Qualitrain devised a bespoke training program, running over just one day, to suit medical device quality compliances and to provide a methodology for continuously reinforcing good practice. The training consisted of many different methods, including individual and group activities, and Qualitrain devised and provided training documents which Surgical Innovations has since used as a point of reference again and again.
 
"In our opinion, the biggest attribute to a Qualitrain training program is the amount of aftercare support offered. I personally contacted Richard Bates several times for his advice on certain methods and validating new equipment. He always replied efficiently and has been a great source of support since undertaking the initial training, to myself and to others in the company.
 
The depth of Qualitrain’s understanding of medical devices and injection moulding was impressive. The IQ, OQ, PQ and CpK language is now in everyday company conversation. I would have no hesitation in recommending Richard Bates validation training to any business." - Nick Bridgman, Production Engineer, Surgical Innovations Limited