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Wednesday, October 04, 2023
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21 CFR Part 820 Training Courses and Certification Programs


Document your dedication to regulations, GxP compliance, quality, consumer safety, and job performance by earning a professional training certification from Biopharma Institute.

Choosing Biopharma Institute to provide training on regulatory and GxP compliance 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 21 CFR Part 820 training certification courses and programs.

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
Method of Training: Online, self-paced eLearning.
Price: $1595.00


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
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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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.

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