Method of Training: Online / Self-paced eLearning.Credits: 1.5 CPD Credits.
Duration: ~1.5 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 $225.00
Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.Training Program: Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
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 and electronic signatures provided by those systems are trustworthy and reliable to the same extent as paper counterparts. The regulation sets out controls and procedures which need to be established and followed for relevant computer systems in FDA-regulated environments. An FDA-regulated environment is a 'GxP' environment operated by an organisation involved in activities leading to the marketing of drugs or medical devices in the USA; examples are drug manufacturing sites, medical device manufacturing sites, analytical laboratories, clinical investigational sites, and nonclinical study laboratories.
21 CFR Part 11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form- that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records- from a humble spreadsheet program to a complex information management system.
Companies that market or intend to apply for approval to market drugs or medical devices in the USA must comply with 21 CFR Part 11, whether or not they are based in the USA. Suppliers to such companies of materials, equipment, or data that are subject to FDA regulation must also comply.
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.
The Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures Course is Included in the Following Professional Certification Programs:
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