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Medical Device Quality Management Professional Certification Program (MD00S3)

Certification Training
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Duration: See individual courses below for time requirements.
Method of Training: Online / Self-paced eLearning.
Credit Hours: See individual courses located below for total credits assigned to this program.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the Biopharma Institute for more information.

Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.

Training Provided By: Biopharma Institute


This online certification program supplies an introduction to the requirements of a Corrective and Preventive Action (CAPA) system; provides a description of how to identify existing problems, correct them, and execute controls that will help to prevent possible problems; describes the essentials necessary for an efficient quality management process, safe products, and continued customer satisfaction. The student will be introduced to medical device records, requirements, and their documentation; as well as their controls. The course taker will also be educated as to the control, implementation, and development of how records and documentation provide the foundation of a Quality Management System, such as compliance with ISO 13485 standards and the FDA CFR 820 QSRs (Quality System Regulations). Those taking this course will be educated on the maintenance and requirements involving a QMS (Quality Management System). The following individual courses are included in this online program: An Introduction to the Regulation of Medical Devices; CAPA Systems; Documentation and Records; and Managing a QMS.

Once all course requirements have been satisfied, a Professional Certification has been achieved. Course takers can take the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

If you seek a method through which to train your employees economically without having to set aside an entire day for them to attend a live course, we here at BioPharma Institute are a training partner you can rely on. We will cater to both small-scale and large-scale training requests, customizing your and your employees education. Throughout many of our courses, students will engage in active learning through the help of videos, recorded and live seminars, books, and more.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Biopharma Institute LogoThe Medical Device Quality Management Professional Certification Program includes these individual courses:

GMP: Good Documentation Practice: Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, ma | Learn more...
Duration: 1.0 CPD Credit Hours

GMP: Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture: A company's Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not | Learn more...
Duration: 1.0 CPD Credit Hours

An Introduction to the Regulation of Medical Devices: This program provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in E | Learn more...
Duration: 1 CPD Credit Hours

Medical Device Quality Management: Managing a QMS: This course teaches the student about the maintenance of a quality management system (QMS). Course objectives include training how to recognize the importance of measurin | Learn more...
Duration: ~1-2 Hours

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization

Contact Us:

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

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