Best Practice in Product and Process Improvement. Current and Emerging Regulations & Standards. Etc. …

CAPA - Corrective and Preventive Action.
Information | Understanding | Best Practices.
An effective "CAPA" or "Corrective and Preventive Action" process is an essential component in any modern Quality Management System. In every process; errors, deviations and failures can arise. However, it is critical that if and when deviations to expected norms of performance are identified, that they are effectively and permanently addres...
 
CAPA - Corrective and Preventive Action.
Information | Understanding | Best Practices.
In risk assessment, the widely applied practice is for a determination of the “probability” of the risk arising to be estimated, then an additional estimate is made of the potential impact or “severity” associated with the risk. These two estimates of “probability” and “severity” are given numbers or ratings, based on pre-det...
 
Kanban
Information & Training. | Lean Manufacturing. Just In Time Processing.
The widely quoted reasons for implementing Kanban 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 poss...
 
Kanban
Information | Understanding | Best Practice.
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,...
 
MDR 2017 745
Information & Training. | Medical Devices.
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 ...
 
MDR 2017 745
Quality System Management Review.
Information | Understanding | Best Practice.
The objective of the Management Review is to ensure that the Quality System is suited to business needs, is 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 meet...
 
Quality System Management Review.

MedicalDeviceValidation-small_03
Information & Training presentations. … …