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Wednesday, October 04, 2023
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FDA 21 CFR Part 11 Electronic Records and Signatures Training Courses and Certification Programs


FDA 21 CFR Part 11 Electronic Records and SignaturesDocument your dedication to FDA 21 CFR Part 11 Electronic Records and Signatures by earning a professional training certification from Biopharma Institute.

Choosing Biopharma Institute to provide training on FDA 21 CFR Part 11 Electronic Records and Signatures 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 FDA 21 CFR Part 11 Electronic Records and Signatures training certification courses and programs.

Electronic Records & Signatures Training Programs:


Certification Training 21 CFR Part 11 - Electronic Records & Signatures Professional Certification Program
Professional Certification Program:

21 CFR Part 11 – Electronic Records & Signatures Professional Certification Program

Course ID: ESRPRO
Method of Training: Online, self-paced eLearning.
Price: $885.00


Certification Training Clinical Trial eSystems Inspection Readiness
Individual Course w/Certificate of Completion:

Clinical Trial eSystems Inspection Readiness

Course ID: CP021a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
Individual Course w/Certificate of Completion:

Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)

Course ID: ESR01A
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $225.00


Certification Training 21 CFR Part 11 - An Introduction
Individual Course w/Certificate of Completion:

21 CFR Part 11 – An Introduction

Course ID: ELM-112
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training 21 CFR Part 11 - Electronic Records
Individual Course w/Certificate of Completion:

21 CFR Part 11 – Electronic Records

Course ID: ELM-114
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training 21 CFR Part 11 - Electronic Signatures
Individual Course w/Certificate of Completion:

21 CFR Part 11 – Electronic Signatures

Course ID: ELM-115
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training 21 CFR Part 11 - 2003 Guidance
Individual Course w/Certificate of Completion:

21 CFR Part 11 – 2003 Guidance

Course ID: ELM-116
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Other Programs for Data and Documentation Professionals


Certification Training Data Integrity Professional Certification Program
Professional Certification Program:

Data Integrity Professional Certification Program

Course ID: DATAINT
Method of Training: Online, self-paced eLearning.
Price: $995.00


Certification Training Data Integrity: An Introduction to Data Integrity
Individual Course w/Certificate of Completion:

Data Integrity: An Introduction to Data Integrity

Course ID: ELM-148
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: Health Authority Expectations
Individual Course w/Certificate of Completion:

Data Integrity: Health Authority Expectations

Course ID: ELM-151
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: ALCOA and ALCOA+
Individual Course w/Certificate of Completion:

Data Integrity: ALCOA and ALCOA+

Course ID: ELM-152
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity:  Good Documentation Practice (GDocP)
Individual Course w/Certificate of Completion:

Data Integrity: Good Documentation Practice (GDocP)

Course ID: ELM-153
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: Computer System Validation (CSV) Best Practices
Individual Course w/Certificate of Completion:

Data Integrity: Computer System Validation (CSV) Best Practices

Course ID: ELM-154
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: Data Governance
Individual Course w/Certificate of Completion:

Data Integrity: Data Governance

Course ID: ELM-155
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.


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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.