ESIG Training

 

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Electronic Records, Electronic Signatures
(ESIG), Authentication, and Encryption
Training Course Description

Who Should Attend: - The course is designed for project managers and project teams from pharmaceutical research, manufacturing, laboratory, and regulatory affairs organizations who use computer systems to generate, store, and transfer records. Information systems managers and specialists who evaluate and recommend such computer systems, or their support infrastructures of networks and servers, will also benefit from attending the course.

Course Format: - Lecture, Demonstration, & Case Study Simulation – Four 90-minute units

The course is an introduction to commercial data authentication / encryption, and an overview of current information systems security practices. The course has a strong emphasis on compliance with FDA Rule 11 "Electronic Records; Electronic Signatures." The presentations alternate between lectures and either case studies or technology demonstrations. Participants are strongly encouraged to develop and discuss "real-world" applications of the subject material.

Course Outline:

bulletUnit 1 - Authentication (Electronic Signatures) &
              Encryption (Electronic Records)
bulletUnit 2 - FDA Rule - 21 CFR Part 11
              "Electronic Records; Electronic Signatures"
bulletUnit 3 - Pragmatic Applications of Cost-Effective, Compliant
              Electronic Records & Signatures
bulletUnit 4 - Validating Site and System Security
              (Including Internet / Intranet Security)

Benefits: - Participants in the course acquire an immediate appreciation for the capabilities of commercially available data security products. They gain the knowledge required to evaluate the many different approaches to deploying this technology. Participants get "hands on" experience with the hardware and software, allowing them to critique vendor demos and proposals.

When the course is taught on-site, the participants have the opportunity to question the instructor about their specific situations in a confidential environment. The instructor can make specific recommendations, suggesting strategies to improve the participants’ system security.

Logistics:

The Hollis Group supplies staff, materials, and equipment including:

bulletOne instructor, experienced in selecting and deploying security technology
bulletPresentation materials (multiple formats available), student workbooks
bulletComputer system for data authentication / encryption demonstration
bulletIndustry-specific case study, including SOP’s, raw material specifications, assay results, product formulations, operator ID’s, passphrases, keys, etc.

Note: The customer is required to supply classroom facilities, audiovisual equipment, etc. If required, The Hollis Group can arrange conference facilities near Paoli, PA.

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For technical questions or comments (including typos), send email to: tquinn@hollisgroup.com