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

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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.

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

Subcategories (Areas of specialty or focus):

• 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

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Medical Device Courses and Programs:

	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	Enroll Here
	Professional Certification Program: ISO 13485:2016 Professional Certification Program Course ID: ISOPCRT Average Learning Time: See Program Webpage Price: $1295 | Learn More	Enroll Here
	Training Program for Professionals: ISO 14971:2019 for Professionals Course ID: ISOPRO Average Learning Time: See Program Webpage Price: $995 | Learn More	Enroll Here
	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	Enroll Here
	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	Enroll Here
	Training Program for Professionals: Medical Device Validation for Professionals Course ID: MDVAL Average Learning Time: See Program Webpage Price: $495 | Learn More	Enroll Here
	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	Enroll Here
	Individual Course w/Certificate of Completion: ISO 14155:2020 Medical Device Standard Course ID: CP008a Average Learning Time: 45 minutes Price: $199 | Learn More	Enroll Here

	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here
	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	Enroll Here

• 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

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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.

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