Duration: 1.5 hours, Online (the average time to complete the training program, including final assessments).Credits Hours: 1
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $149.00
Training Program: Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This course details the regulatory expectations for quality management system (QMS) certification, identifies vital elements of the essential and standard administration roles, and explains how ISO 13485:2003 (the ISO standard) relates to the medical device industry. The key differences between ISO13485 medical device and ISO 9000 QMS are presented and discussed. The course objectives are to recognize how the QMS is to be certified by an external auditing authority, to identify some key roles in administration of the QMS, to identify the resources needed and the key areas of the QMS, and to state how ISO 13485:2003 relates to the medical device industry. This course is also included in the Global Medical Device Regulatory Affairs Professional Certification Program.
Once all course requirements have been satisfied, a certificate of completions is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
Over the years, the BioPharma Institute, in addition to providing online training, has also been relevant in the development of other healthcare and biotechnology businesses. We have also worked with many leading corporations, worldwide.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements course is found in the following professional certification program(s):
4. Why Use ISO13485:2003?
5. Applying ISO13485:2003
6. Defining A QMS
9. Key Areas Of The QMS
10. ISO9000 Vs ISO13485
11. Resource Management
12. Product Realization
13. Planning For Product Realization
14. Customer-Related Processes
15. Design & Development
16. Purchasing & Vendor Assurance
17. Production & Service Provision
18. Control Of Production Processes
ANALYSIS, IMPROVEMENT & DOCUMENTS
19. Measurement & Analysis I
20. Measurement & Analysis II
21. Measurement & Analysis III
23. QMS Documentation
24. Company Responsibilities
25. Review I
26. Review II
CERTIFYING THE QMS
27. Iso 13485 Certification
28. What To Expect During An Audit
State how ISO 13485:2003 relates to the medical device industry
Identify the key areas of and resources needed for the Quality Management System (QMS)
Identify some key roles in administration of the QMS
Recognize how the QMS is to be certified by an external auditing authority.
Online Training Program Benefits:
- Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.