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Wednesday, March 22, 2023
Home » Medical Device GMP Compliance and Regulatory Affairs Training Certification Courses

Medical Devices: cGMP & Regulatory Affairs Training Courses and Professional Certification Programs


Medical DevicesDocument your dedication to medical device GxP compliance, consumer safety, and job performance by earning a professional training certification from Biopharma Institute.

Choosing Biopharma Institute to provide medical device regulatory or GxP compliance training demonstrates the importance you place on receiving a reliable, accurate, and high-quality instruction with an emphasis on producing products or services which are safe for the consumers or patients to use. Students earning a certificate of training from Biopharma Institute have an established appreciation for regulatory and compliance and have presented a strong understanding of the subject matter taught. Below is our list of training courses and professional certification programs for cGMP compliance and the regulation of medical devices.

Medical Devices:
Popular Programs & Training Categories


Medical Device Courses and Programs:

Core Medical Device Programs & Courses:


Certification Training 21 CFR Part 820: Medical Device cGMP Professional Certification Program
Professional Certification Program:

21 CFR Part 820: Medical Device cGMP Professional Certification Program

Course ID: MDPRO
Average Learning Time: See Program Webpage
Price: $1995 | Learn More
Certification Training ISO 13485:2016 Professional Certification Program
Professional Certification Program:

ISO 13485:2016 Professional Certification Program

Course ID: ISOPCRT
Average Learning Time: See Program Webpage
Price: $1295 | Learn More
Certification Training ISO 14971:2019 for Professionals
Training Program for Professionals:

ISO 14971:2019 for Professionals

Course ID: ISOPRO
Average Learning Time: See Program Webpage
Price: $995 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) for Professionals
Training Program for Professionals:

EU Medical Device Regulation (EU MDR) for Professionals

Course ID: EUMDR
Average Learning Time: See Program Webpage
Price: $1295 | Learn More
Certification Training Medical Device Single Audit Program (MDSAP) for Professionals
Training Program for Professionals:

Medical Device Single Audit Program (MDSAP) for Professionals

Course ID: MDSAP
Average Learning Time: See Program Webpage
Price: $1195 | Learn More
Certification Training Medical Device Validation for Professionals
Training Program for Professionals:

Medical Device Validation for Professionals

Course ID: MDVAL
Average Learning Time: See Program Webpage
Price: $495 | Learn More
Certification Training Introduction to the Regulation of Medical Devices
Individual Course w/Certificate of Completion:

Introduction to the Regulation of Medical Devices

Course ID: MDA0
Average Learning Time: 60 minutes
Price: $195 | Learn More
Certification Training ISO 14155:2020 Medical Device Standard
Individual Course w/Certificate of Completion:

ISO 14155:2020 Medical Device Standard

Course ID: CP008a
Average Learning Time: 45 minutes
Price: $199 | Learn More

21 CFR Part 820 cGMP Medical Device Programs:


Certification Training cGMP: Introduction to Good Manufacturing Practice, An Abridged Course
Free Trial Course:

cGMP: Introduction to Good Manufacturing Practice, An Abridged Course

Course ID: GMP00
Average Learning Time: 10 minutes
Free Course: Start Learning, Today! Learn More
Certification Training GMP: 21 CFR Part 820 Subpart A - General Provisions
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart A – General Provisions

Course ID: ELM-301
Average Learning Time: 30 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart B - Quality System Requirements (QSR)
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart B – Quality System Requirements (QSR)

Course ID: ELM-302
Average Learning Time: 30 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart C - Design Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart C – Design Controls

Course ID: ELM-303
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart D - Document Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart D – Document Controls

Course ID: ELM-304
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart E - Purchasing Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart E – Purchasing Controls

Course ID: ELM-305
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart F - Identification and Traceability
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart F – Identification and Traceability

Course ID: ELM-306
Average Learning Time: 60 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart G - Production and Process Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart G – Production and Process Controls

Course ID: ELM-307
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart H - Acceptance Activities
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart H – Acceptance Activities

Course ID: ELM-308
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart I - Nonconforming Products
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart I – Nonconforming Products

Course ID: ELM-309
Average Learning Time: 60 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart J - Corrective and Preventive Action
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart J – Corrective and Preventive Action

Course ID: ELM-310
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart K - Labeling and Packaging Control
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart K – Labeling and Packaging Control

Course ID: ELM-311
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation

Course ID: ELM-312
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart M - Records
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart M – Records

Course ID: ELM-313
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart N - Servicing
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart N – Servicing

Course ID: ELM-314
Average Learning Time: 45 minutes
Price: $199 | Learn More
Certification Training GMP: 21 CFR Part 820 Subpart O - Statistical Techniques
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart O – Statistical Techniques

Course ID: ELM-315
Average Learning Time: 45 minutes
Price: $199 | Learn More

Additional Medical Device Courses Not Listed Above


Online Training – The Benefits of eLearning:

  • Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: Courses are current with respect to regulations, procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
  • Flexible final assessments: Assessments 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 requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
  • Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
  • Reimbursement: Some employers may reimburse their employees for training expenses. Check your company’s education reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
  • Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.