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Kanban Pull Process
The widely quoted reasons for implementing Kanban pull processes within an organization are often given as benefits associated with reduced inventory levels, operational efficiency gains, operating cost reductions, product quality benefits, more responsive delivery, enhanced supplier responsiveness, reduction and possible elimination of incoming, in-process and final inspections points, ...
 
Kanban Pull Process
Quality Management System Training Presentation
In every business, where products or services are supplied into the organization, there is a critical need for an effective and efficient supplier quality planning program. The success of a business is directly impacted by the ability of suppliers to consistently deliver to required specifications (specifications include quality, reliability, time and cost expectations). Failure by a sup...
 
Quality Management System Training Presentation
Planned EU Medical Device Regulation changes.
EU Medical Device Regulation changes?

The current EU regulatory framework for medical devices, (excluding in-vitro diagnostic medical devices), consists of Council Directive 90/385/EEC for active implantable medical devices (AIMDD) and Council Directive 93/42/EEC for medical devices (MDD) which cover a huge spectrum of products. These directives have over time been updated and supplem...
 
Planned EU Medical Device Regulation changes.
Quality System Management Review.
The objective of the Management Review is to ensure that the Quality System is suited to business needs, efficient and effective. The review should assess performance over the previous period (since the previous Management Review), opportunities for improvement, confirm that the quality policy and objectives remain appropriate and are meeting the needs of the organisation and it's "quali...
 
Quality System Management Review.
FDA GMP Quality System Regulation: Handling, Storage, Distribution and Installation.
The primary objective of a Quality Assurance Audit is to gather information related to the on-going status of a process and then applying the information gathered to evaluate the performance of the process against defined criteria. When performing an audit you are reviewing the activities, the records, processes, systems, user experiences, competences, etc., in place and seeing how they ...
 
FDA GMP Quality System Regulation: Handling, Storage, Distribution and Installation.
Validation Master Plan
The Validation Master Plan is a document which aims to serve a number of purposes.

 
i) It outlines the approach to be taken by an organization when conducting validations.
ii) It defines the rational for performing validations versus the implementation of verification activity.
iii) The validation master plan outlines the criteria for the determination of criticality which ...
 
Validation Master Plan

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