Method of Training: Online / Self-paced eLearning.Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Electronic Records.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.Training Program: Electronic Signatures & Records - 21 CFR Part 11
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
The Food and Drug Administration established a set of rules for electronic signatures and electronic records back in 1997. The Electronic Signatures & Records- 21 CFR Part 11 Course is designed to explain why these regulations were developed, and the roles they play in accordance to other sections of 21 CFR. Students will have the chance to explore the general concepts of security in a Part 11 compliant system. Course completion requirements include passing an online, multiple-choice final assessment.
Benefits of Getting Certified at BioPharma Institute
For over two decades, BioPharma Institute has been providing comprehensive and flexible online training solutions for thousands of organizations across the pharmaceutical, healthcare, and biotechnology industries. Our eLearning solutions make it extremely convenient for professionals to upgrade their skills within a flexible schedule, and without having to allocate time to conduct or attend live training programs.
Each course is designed to engage students via an active learning process with tools such as live and recorded seminars, online books, high quality animations, and more. You can rest assured that we cater to both small-scale and large-scale training requests as well.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Full List of Programs in the Electronic Records Catalog:
|Compliance in Electronic Signatures & Records Professional Certification Program: The Compliance in Electronic Signatures & Records Professional Certification Program covers two areas of training, including and introduction to compliance and compliance with specific respect to regulation 21 ... Learn more|
|Electronic Signatures & Records - 21 CFR Part 11: The Food and Drug Administration established a set of rules for electronic signatures and electronic records back in 1997. The Electronic Signatures & Records- 21 CFR Part 11 Course is designed to explain why t ... Learn more|
|Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures: Part 11 of Title 21 of the US Code of Federal Regulations (21CFR11) sets out requirements that computer systems must meet to satisfy the Food and Drug Administration (FDA), and to assure that electronic records ... Learn more|
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days
- Flexible final assessments: Assessment testing 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 course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization