Training Course Syllabus:
21 CFR Part 11 Electronic Records/Electronic Signature and FDA-Regulated Computer Systems Webinar
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Carolyn Troiano
This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a regulated environment.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. FDA´s 21 CFR Part 11 was enacted in 1997, and is still in force today.
ER/ES capability can improve efficiency and effectiveness, but at a cost, which is not just purely monetary (i.e., purchase of technology), but can result in some operational constraints. There are best practices used in the FDA-regulated arena, and these can be leveraged to develop a standard and consistent approach to ER/ES within a company.
The attendee will learn how to develop a standard approach to establishing and maintaining the use of ER/ES to handle records and approvals in compliance with the FDA regulated environment. There are specific best practices that should be considered before choosing to implement these capabilities and operate in a "paperless" environment. We will discuss the pros and cons for using ER/ES, and talk about the ramifications of choosing to do so. The attendee will be prepared to make a determination about applying ER/ES capabilities in their workplace, and will be able to implement the best practices for maintaining ER/ES in a compliant manner.
While this is an advanced course, and most people will be fairly well familiar with the concepts of computer system validation in an FDA-regulated environment, we will touch on those areas that are critical to 21 CFR Part 11, including security and newer technologies that are emerging for capturing, analyzing, storing and reporting information for decision-making purposes.
It´s important to look at what are some of the threats and challenges, and what methods you can use to mitigate these. Similarly, it is important to identify opportunities that might help companies decrease the cost of compliance and improve operational efficiencies and effectiveness through the use of ER/ES.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective techniques and tools available to assure compliance when managing activities related to handling data.
Objectives of the Presentation:
The course will focus on the use of ER/ES in the FDA-regulated marketplace, which may be of interest in a drive to reduce costs and improve compliance. While ER/ES use can be beneficial, there are some caveats that will be discussed in detail through examples.
We will present best practices and principles for establishing and maintaining
computer system compliance while using ER/ES capability in an FDA-regulated
environment (i.e., the system "touches" product during the manufacturing,
testing or distribution of the product, or during any other functional
activity). The result will be a prescriptive approach to helping teams and
individuals reach a higher level of compliance.
FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how everyday work, along with the challenges and risks should be managed.
Who Should Attend:
Information technology analysts, project managers,
organizational change managers, business process engineers, QC/QA managers and
analysts, clinical data managers and scientists, analytical chemists, compliance
managers, lab managers, automation analysts, computer system validation
specialists, GxP training specialists, business stakeholders and individuals who
are responsible for computer system validation planning, execution, testing,
reporting, compliance, and audit. This webinar will also benefit consultants,
contractors or vendors providing products and services to the life sciences
industries and who are involved in computer system implementation, validation