New course on 21CFR11

Wed 24 May 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course, ICT01: 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) 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.

21CFR11 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 ñ that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records ñ 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 21CFR11, 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.

This course provides essential training for all personnel who use computer systems in GxP environments. It clarifies the complicated picture of regulatory requirements and enforcement discretion exercised by the FDA.


Course update: The New Drug Application (NDA) for Marketing Approval in the USA

Fri 5 May 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has released an updated version of its course on applications to the US Food and Drug Administration (FDA) for marketing approval of new drugs.

Course SUB09, The New Drug Application (NDA) for Marketing Approval in the USA, has been updated to take account of the FDA’s commitment letter for authorisation VI of the Prescription Drug User Fee Act, which applies for US fiscal years 2018 through 2022. In addition, information on submission of applications has been updated in accordance with the FDA’s requirements for mandatory use of electronic Common Technical Document (eCTD) formatting and for transmission via its Electronic Submissions Gateway from 5 May 2017.

Information has also been updated on expedited development and review programmes and on communications and meetings between applicants and the FDA.