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Home » 21 CFR Part 820 - Medical Device Professional Certification

21 CFR Part 820 - Medical Device Professional Certification (MDPRO)

Certification TrainingDuration: 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.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $2495.00

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

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Description:

Review the individual courses included in this program (see below) for program descriptions and outlines.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade. Once all course requirements have been satisfied, a professional certification has been achieved.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Biopharma Institute Logo21 CFR Part 820 - Medical Device Professional Certification includes these individual courses:



21 CFR Part 820 Subpart A - General Provisions: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 30 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart B - Quality System Requirements: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 30 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart C - Design Controls: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart D - Document Controls: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart E - Purchasing Controls: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart F - Identification and Traceability: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 60 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart G - Production and Process Controls: In this course you will learn about how each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specif | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart H - Acceptance Activities: In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonizatio | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart I - Nonconforming Products: In this course you will learn about nonconforming product and product that fails to meet a requirement, need, expectation or obligation and how each manufacturer shall es | Learn more...
Duration: 60 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart J - Corrective and Preventive Action: The Corrective and preventative actions, or CAPA, system is arguably the most important subsystem of the QMS. It is the location where issues are documented and tracked i | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart K: Labeling and Packaging Control: Labeling may seem like a relatively simple topic, bit it is a very complicated topic with regards to medical devices. Before we go too far, let's start with the basic def | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation: Just because we designed the product correctly, and made the product correctly, doesn't mean we are done. Handling, storage, distribution and installation of the product | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart M - Records: Records are what we create to provide the evidence that we are following our procedures; therefore, they are extremely critical. It is important to remember that the reco | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart N - Servicing: As servicing is not required of all medical devices, this subpart of the regulations is one of the more commonly excluded regulations from an organization's quality syste | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

21 CFR Part 820 Subpart 0 - Statistical Techniques: By the end of this course you will have learned, how each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for e | Learn more...
Duration: 45 minutes (0.1 CPD Credits)

Online Training: The Benefits of Remote Learning & 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 training reimbursement policy.
  • 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.

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