21 CFR Part 11 - Electronic Records
Enrollment Period: 12 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online, asynchronous, self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Electronic Records.
Demonstration: Three (3) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: 21 CFR Part 11 - Electronic Records
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
The main objectives of this course are to give learners a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). This online course provides an overview of the FDA requirements with practical examples covering the implementation of those requirements.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
Who should take this course?
Subpart B - Electronic Records
Electronic Records Requirements
Controls for a Closed System - 21 CFR Part 11.10
21 CFR Part 11.10(a) - Computer System Validation (CSV)
21 CFR Part 11.10(a) - CSV Process
21 CFR Part 11.10(a) - CSV Top Tips
21 CFR Part 11.10(a) - CSV Documentation
21 CFR Part 11.10(b) - Accurate and Complete Records
21 CFR Part 11.10(b) - Printable
21 CFR Part 11.10(b) - File Formats
21 CFR Part 11.10(c) - Protection of Records
21 CFR Part 11.10(c) - Data Backup, Recovery, Archiving & Disaster Recovery
21 CFR Part 11.10(d) - Limited System Access
21 CFR Part 11.10(e) - Audit Trails
21 CFR Part 11.10(f) - Operational Checks
21 CFR Part 11.10(g) - Authority Checks
21 CFR Part 11.10(h) - Device Checks
21 CFR Part 11.10(i) - Personnel Qualification
21 CFR Part 11.10(j) - Polices for Using Electronic Signatures
21 CFR Part 11.10(k) - Documentation Controls
21 CFR Part 11.10(k) - Documentation Controls Tips
21 CFR Part 11.30 - Controls for Open Systems
21 CFR Part 11.50 - Signature Manifestation
21 CFR Part 11.50 - Signature / Record Linking
This training program has been developed to train employees with Advanced Knowledge of 21 CFR Part 11, Compliance with Electronic Records and Signatures.
21 CFR Part 11 - Electronic Records is included in the following professional certification programs:
21 CFR Part 11 - Electronic Records & Signatures Professional Certification ProgramCourse ID: ESRPRO
Price: $885.00.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Benefits of Training with Biopharma Institute
|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:||Certificate of completion is instantly available once requirements have been fulfilled.|
|Verification of training:||Certificates verifiable online with digital badges 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.|