How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries."

FDA requirements for using electronic records and electronic signatures

Description

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. The use of electronic records and signatures enables a company to conduct business in a paperless environment. However, this is only if the company adheres to the specific requirements put forth by FDA in their guidance for ER/ES. The paperless environment means that all signatures will be obtained through a software-enabled workflow system that routes the key documents to specifically approved signers.

The workflow typically includes tracking of the status of the document, indicating where it is in the approval process. It also allows for signers to reject a document and request that either it be withdrawn altogether or modified in some manner. The key to successful compliance of a paperless workflow and approval environment is setting up the right security and access rights, and authenticating signatures effectively.

Why You Should Attend:

The attendees will learn how to develop a standard approach to establishing and maintaining the use of ER/ES to handle records and approvals in an FDA regulated environment. There are specific best practices that should be considered before choosing to implement these capabilities and operate in a “paperless” environment, and these will be discussed. 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.

We will touch on those areas that are critical to meeting the requirements set forth in FDA’s 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 of using ER/ES, 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.

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Areas Covered

•        FDA's 21 CFR Part 11 guidance for electronic records and signatures
•        Pros and cons of implementing ER/ES capability
•        Cost-benefit analysis of implementing ER/ES capability
•        Risks associated with ER/ES implementation and potential mitigation
•        Organizational change management required to successfully implement and using ER/ES capability
•        Key roles and responsibilities required in the process of implementing, using and supporting systems with                 ER/ES capability        
•        Documenting ER/ES rationalization
•        Preparing for an FDA audit that will include scrutiny of applications with ER/ES capability
•        Examples of companies that have implemented ER/ES capability and discuss the rationale behind it, cost-                 benefit analysis conducted, risk assessment conducted and some of the outcomes, both successful and                     unsuccessful Compliance and Audit Managers

Who will Benefit

•        Information Technology Analysts
•        Information Technology Developers and Testers
•        QC/QA Managers and Analysts
•        Clinical Data Managers and Scientists
•        Analytical Chemists
•        Laboratory Managers
•        Automation Analysts
•        Computer System Validation Specialists
•        GMP Training Specialists
•        Business Stakeholders/Subject Matter Experts
•        Business System/Application Testers
•       This webinar will also benefit any consultants working in the tobacco or life science industries who are                         involved in computer system implementation, validation and compliance.

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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