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.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.