Instructor Profile

Some say, that CAPA – Corrective and Preventive Actions – are the most important process of any Quality Management System. This is more intensified in the Medical Devices industry where the ability of an organization to ensure that failures do not reoccur is one of the most important goals of Quality Systems and hence reducing. FDA, EU Notified Bodies, and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions. Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions, and corrective actions in a duly manner.

This webinar shall provide insight into how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its failures and avoid future non-conformities. Mr. Yuval Shapiro will discuss the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice. The difference between Correction, Corrective Action, and Preventive Action will be discussed. Mr. Shapiro will also discuss common sources for CAPA and root-cause analysis tools, such as Why diagrams, cause-and-effect diagrams, Pareto charts, etc. An efficient CAPA management system will also be presented.

The business environment is becoming more competitive. Many businesses promote quality as a core customer value and see it as a critical success factor in achieving competitiveness.

How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!

The purpose of a firm is to Make Money, the purpose of a QMS is to enable the firm to produce, and therefore - generate money with minimum losses that are reflected by failures.

The principles are known, but it is done? 

This lecture will give the listener the basic know-how to establish a Cost of Quality mechanism for a company: Easy to gather data, easy to implement, and easy to support!

Risk management is an essential component of any Quality Management System, but businesses are struggling to keep up with regulatory updates and the impact on their QMS.

Significant changes in the regulatory environment have shifted to risk-based processes, emphasizing the Risk Management files for medical-related products. ISO 14971:2019 was published to harmonize those concepts across multiple regulatory bodies, as well as to incorporate some significant changes in the existing risk management landscape.

Concerning the transition to ISO 14971:2019, the FDA has stated that it will continue to accept declarations of conformity to the previous version, ISO 14971:2007, in support of premarket submissions until December 25, 2022. "After this transition period, declarations of conformity to [ISO 14971:2007] will no longer be accepted,"

Risk approach has become a mandatory practice during the Product Realization of Medical Devices. This practice should be applied as per ISO14971: 2019, the brand-new revision of the well-known and practice standard.