Medical Devices: cGMP & Regulatory Affairs Training Courses and Professional Certification Programs
Document 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
Popular Programs & Training Categories
- Professional Certifications:
- US Medical Device Quality Assurance (QA) Management Professional Certification Program
- FDA 21 CFR Part 820: Medical Device cGMP Professional Certification Program
- ISO 13485:2016 Professional Certification Program
- EU MDR: EU Medical Device Regulation for Professionals
- MDSAP: Medical Device Single Audit Program for Professionals
- Medical Device Validation for Professionals
- Regulatory Affairs: Introduction to the Regulation of Medical Devices
- EU MDR: EU Medical Device Regulation
- MDSAP: Medical Device Single Audit Program
- FDA 21 CFR Part 820: US cGMP for Medical Devices
- FDA Inspection Readiness (GMP Auditing)
- ISO 14971:2019 Medical Devices
- ISO 13485:2016 Medical Devices
- ISO 14155:2020 Clinical Research of Medical Devices Standard
- Validation of Medical Devices
- Change Control: Systematic Method to Manage Change
- Root Cause Analysis & CAPA
- cGMP for Beginners
- cGMP for Combination Products: Pharmaceuticals & Medical Devices
- China CFDA: cGMPs
Subcategories (Areas of specialty or focus):
Core Medical Device Programs & Courses:
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US Medical Device Quality Assurance (QA) Management Professional Certification ProgramCourse ID: QADPRO |
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21 CFR Part 820: Medical Device cGMP Professional Certification ProgramCourse ID: MDPRO |
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ISO 13485:2016 Professional Certification ProgramCourse ID: ISOPCRT |
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ISO 14971:2019 for ProfessionalsCourse ID: ISOPRO |
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EU Medical Device Regulation (EU MDR) for ProfessionalsCourse ID: EUMDR |
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Medical Device Single Audit Program (MDSAP) for ProfessionalsCourse ID: MDSAP |
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Medical Device Validation for ProfessionalsCourse ID: MDVAL |
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
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ISO 14155:2020 Medical Device StandardCourse ID: CP008a |
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GMP: 21 CFR Part 820 Subpart A – General ProvisionsCourse ID: ELM-301 |
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GMP: 21 CFR Part 820 Subpart B – Quality System Requirements (QSR)Course ID: ELM-302 |
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GMP: 21 CFR Part 820 Subpart C – Design ControlsCourse ID: ELM-303 |
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GMP: 21 CFR Part 820 Subpart D – Document ControlsCourse ID: ELM-304 |
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GMP: 21 CFR Part 820 Subpart E – Purchasing ControlsCourse ID: ELM-305 |
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GMP: 21 CFR Part 820 Subpart F – Identification and TraceabilityCourse ID: ELM-306 |
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GMP: 21 CFR Part 820 Subpart G – Production and Process ControlsCourse ID: ELM-307 |
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GMP: 21 CFR Part 820 Subpart H – Acceptance ActivitiesCourse ID: ELM-308 |
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GMP: 21 CFR Part 820 Subpart I – Nonconforming ProductsCourse ID: ELM-309 |
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GMP: 21 CFR Part 820 Subpart J – Corrective and Preventive ActionCourse ID: ELM-310 |
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GMP: 21 CFR Part 820 Subpart K – Labeling and Packaging ControlCourse ID: ELM-311 |
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GMP: 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and InstallationCourse ID: ELM-312 |
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GMP: 21 CFR Part 820 Subpart M – RecordsCourse ID: ELM-313 |
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GMP: 21 CFR Part 820 Subpart N – ServicingCourse ID: ELM-314 |
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GMP: 21 CFR Part 820 Subpart O – Statistical TechniquesCourse ID: ELM-315 |
Additional Medical Device Courses Not Listed Above
- EU MDR: Individual Courses
- MDSAP: Individual Courses
- FDA Inspection Readiness (GMP Auditing) Individual Courses
- ISO 14971:2019 – Individual Courses
- ISO 13485:2016 – Individual Courses
- Validation of Medical Devices – Individual Courses
- cGMP for Combination Products: Individual Courses
- China CFDA: cGMPs
Online Training – The Benefits of eLearning:
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 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: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company’s policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
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.
