Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
 | Enrollment Period: 6 months. Average Learning Time: ~90 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 1.5 CPD Credits. Method of Training: Online / Self-paced eLearning. Accessibility: 24/7 access to all program materials. Catalog: Electronic Records.Demonstration: Five (5) 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: $225.00 USD |
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  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 organization 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. Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. 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. |
Outline:Course Overview- An outline of the course scope and objectives, and notes on terminology. 21 CFR Part 11 and its scope- We define regulation 21 CFR Part 11, explain its purpose, and set out criteria for identifying the environments, computer systems, electronic records, and electronic signatures to which it applies. We describe how underlying legal requirements are specified by predicate rules. We point out that it is not the type of computer system that determines whether Part 11 applies, but the use to which the system is put. Finally, we introduce the regulation's distinction between closed and open systems. Procedures and controls- We describe the procedures and controls that need to be established and followed to comply with Part 11. We identify those for which the FDA exercises enforcement discretion. We give examples of open systems and outline additional procedures and controls required for them. Electronic signatures- We set out Part 11's requirements for electronic signatures. We specify the information to be provided and we outline constraints on the way signatures are linked to records. We emphasize the importance of uniqueness of signatures and verification of the identity of signatories. We mention the need for one-off certification with the FDA. We outline components of non-biometric and biometric signatures. Finally, we set out procedures and controls required for user names and passwords. FDA enforcement discretion- We describe the FDA's narrow interpretation of Part 11, and its effect on the need to comply with some of the regulation's provisions. We discuss the latest relevant FDA guidance for industry and the effect of the agency's interpretation on its enforcement of compliance with requirements for validation, audit trails, record retention, and record copying. We also specify the exemption for legacy computer systems. Assessment- Multiple-choice mastery assessment. | Objectives:Who will benefit from this module? This module provides essential training for all personnel who use computer systems in GxP environments. Learning objectives:
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Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures) is included in the following professional certification programs:
 | Computer System Validation for ProfessionalsCourse ID: VAL00S2Price: $695.00 (USD) | Learn more | |
 | 21 CFR Part 11 - Electronic Records & Signatures Professional Certification ProgramCourse ID: ESRPROPrice: $885.00 (USD) | Learn more |
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