Medical Training in Boston, MA

This course has been designed to help you understand the process validation concepts for medical devices and pharmaceutical products. This also covers the following: Determining which process must require validation Evaluate if the process is capable Monitors and controls for the process Statistical methods Software qualifications Course Benefits...

This course has been designed to help you understand the Quality System requirements including FDA perspective and how to implement. Course Benefits Participants will understand the QSR, FDA requirements and how ISO 9001 and QSR can be deployed. Topics Covered: What are QS Regulations The FDA Philosophy Medical Device Overview Relationship to ISO...

Risk Management for Medical Devices (ISO14971:2007 & EN ISO 14971:2012) This course has been designed to help you understand the requirements for understanding, analyzing, and managing medical device risk using ISO 14971:2007. Participants will understand the standard, determine documentation requirements, and develop implementation strategies....

Our Medical Interpreter certificate courses comply with all IMIA guidelines. Our certificate is recognized internationally as well as domestically by the IMIA and the CCHI as a preparatory course for the Certified Medical Interpreter National Board Exams. Interpreters Associates Inc. also offers a one-of-a-kind student care package, specially designed...

QMS Lead Auditor for ISO 13485:2016 (Exemplar Global TPECS) QPS is an Exemplar Global certified training provider for the following competency units contained in this class. Attendees successfully completing this course will receive a certificate of Attainment for these units. AU- Management System Auditing MD -Medical Devices TL-- Leading Management...

Design Control: Documentation, Implementation, and Improvement This course has been designed to learn design control, design verification, design validation, Design History File (DHF), use concepts and implement, learn about planning (inputs/outputs), and risk analysis to ensure your organization\'s devices meet intended uses / user needs and specified...

QMS Internal Auditor for ISO 13485:2016 (Exemplar Global TPECS) QPS is an Exemplar Global certified training provider for the following competency units contained in this class. Attendees successfully completing this course will receive a certificate of Attainment for these units. AU- Management System Auditing MD- Medical Devices Attendees will learn...

The HAZWOPER standard applies to five 5 groups of employers and their employees, including; employees who are exposed or potentially exposed to hazardous substances including hazardous waste and who are engaged in clean-up operations required by a governmental body, whether federal, state, local, or other involving hazardous substances that are conducted...

OSHA 29CFR 1910.120, the Hazardous Waste Operations and Emergency Response (HAZWOPER) standard states that 24-hours of HAZWOPER training is the minimum requirement for those employees whose job does not require them to handle waste or hazardous materials as part of their job. However, if they are required to respond to such incidents as uncontrolled...

This course has been designed to understand European directives, CE marking and guidance documentation. Course Benefits Participants will understand EU directives and related directives (objectives, history, structure, purpose). Who Should Attend? The target audience for this course consists of executives, top management who work in quality (QA/QC),...

This course has been designed to understand the FDA QSIT. Learn the inspection process, what FDA investigators will look at, and specific subsystems of management / design controls, production / process controls (P&PC), and corrective / preventive actions (CAPA). Course Benefits Participants will understand the FDA and its relationship to QSIT...