Practical Quality Assurance and Regulatory Affairs in the Medical Device Industry(1)

First training program taught entirely in the work environment 


First program taught entirely in the work environment thanks to our exclusive agreement with CardioComm Solutions Inc. EduPharmaCanada achieved an exclusive agreement with CardioComm Solutions Inc.to deliver a state of the art program for its trainees. The agreement guarantees a hands on workshop for 3 months in the medical device industry. The PRACTICAL QUALITY ASSURANCE AND REGULATORY AFFAIRS program is a unique case based training that advances professionals in the QA & RA for the medical device industry. The term “practical” means that we take you out of the classroom and into the company setting where you will learn as you participate in daily challenges of the medical device industry. Upon completion, you will be able to include in your resume the work related experience through our workshop. A special letter of qualifications will be provided for each participant.

Certificate Program of practical Quality Assurance and Regulatory Affairs[2]

 

Level

Entry, Intermediate with upgrade knowledge

Minimum requirements

B SC., nursing, allied health professions, engineering, etc.. Recent graduates welcome

Entry requirements

Interview and language aptitude test

Language

English (participants must be proficient in English language-written and oral)

Mode

In pharmaceutical/medical device company site. Classes, workshops and real case projects

Duration

3 months classes and  workshop in a medical device company

Upon completion

Certificate issued by EduPharma™ Canada

Maximum capacity

10 participants per session



[2] This course is part of the industrial training program created by EduPharma™ in collaboration with CardioComm Solutions Inc. to train employees in the Pharmaceutical and Medical Device industry. This is not a vocational program or a career college or a program approved by the Ministry of Training, Colleges and Universities. This program was designed to support professionals in their career paths.

Program content

  • This course provides participants with the essentials in quality assurance and regulatory affairs to understand the process of regulatory compliance of the medical device industry. You will be exposed to compliance standards (ISO 13485, ISO 14971 and others) as well as regulatory requirements in Canada, US and the EU
  • You will be trained to understand the Quality Management System process as well as Standard Operational Procedures and compliance policies. 
  • Further, the trainees will learn the processes of control of documents, record controls, design and production control, risk management, product verification and validation,  product complaint handling, product recall, CAPA (Corrective and preventative actions), and post marketing surveillance
  • the participation in this program and workshop, the trainees will be training to assist in yearly certification inspections by Notifying Bodies. The program will provide with an in-depth understanding of compliance requirements and the process to respond to inspectional findings through implementing effective remedial actions.
  • In addition, the program will allow the participant to learn the process of internal QMS audits and continuous quality improvement through real situations in the industry settings.

The positions you can apply for after this program are: Advancement in your career and as a Quality Assurance associate/assistant and many different QMS positions.




Program Structure

  • The program is based on 6 learning modules. Each module will take one full week to complete. You will come to classes from Monday to Wednesday, and exams are online. The trainees must pass the exam after each learning module to be able to participate in the workshops and the 2.5 months workshop part of the program.  
  • In addition, each trainees will be assigned a special project that must completed. The results of the project will be presented in a 10 minutes seminar.
  • The trainees will have to pass all exams with a 75% as well as the special project and complete the 2.5 months of workshop to obtain the certificate. 
  • Each trainees will have a detailed workshop plan with objectives and deliverables to be completed in the period established. 


(1) This is not a career college program. This is a short term training in QA. The certificate is issued by EduPharma upon completion of the program. This is not a placement nor employment. This program extends knowledge into Quality Assurance processes. We do not guarantee a job or position after completion of this program.