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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems
Regulated by FDA

By: Carolyn Troiano
More Webinars By Expert
Schedule: 15 March, 2022 (Tuesday)
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Webinar ID : 588

   Countdown for your webinar:

 * 13days
 * 22Hrs
 * 59Mns
 * 39Secs

Download Brochure Request Callback Email Reminder


LIVE WEBINAR OPTIONS

($199) - Live Session for 1 Participant

+INCREASE PARTICIPANTS

1 Participants$199 2 Participants$299 3 Participants$399 4 Participants$449 5
Participants$499 6 Participants$549 7 Participants$599
($269) - Live + Recorded Session ($249) - Live + Transcript ($450) - Live +
Training CD


ON DEMAND OPTIONS

($179) - Transcript ($239) - Downloadable Recorded Session ($350) - Training CD


GROUP SESSION OPTIONS

($799) - Group Session Participants + Recorded

Group Session (10 Participants).
To add extra participants, please contact our Customer Support Team


$
Enroll For Webinar


WEBINAR DETAILS

 * OVERVIEW
 * WHY SHOULD YOU ATTEND?
 * AREA COVERED
 * LEARNING OBJECTIVES
 * WHO WILL BENEFIT?

There are very specific limitations that arise when using ER/ES capability, such
as the elimination of print capability to prevent users from making decisions
based on a paper record as opposed to the electronic record. It also requires
very specific identification of users that ensures the person signing the record
is the same person whose credentials are being entered and verified by the
system. Rule for changing passwords must be rigorously adhered to and the
passwords must be kept secure.

It is critical that the system specify the exact meaning of the signature. It
may be that the person conducted the work, recorded the result, reviewed the
result, or approved the result.

A person may simply be attesting to the fact that they reviewed the work and the
signatures, and there was appropriate segregation of duties (i.e., the person
recording the result is not the same as either the person reviewing or the
person giving final approval). A company must have specific policies and
procedures in place that explicitly state responsibilities and provide guidance
for implementing and using ER/ES capability. These must clarify the 21 CFR Part
11 regulation and provide insight as to the way the company interprets their
responsibility for meeting it.

As FDA continues to evolve and change due to the many factors that influence the
regulatory environment, companies must be able to adapt. New technologies will
continue to emerge that will change the way companies do business. While many of
these are intended to streamline operations, reducing time and resources, some
unintentionally result in added layers of oversight that encumber a computer
system validation program and require more time and resources, making the
technology unattractive from a cost-benefit perspective.

This webinar will cover the key aspects of complying with 21 CFR Part 11 in both
validating systems and maintaining them in a validated state throughout their
entire life cycle.



WHY SHOULD YOU ATTEND?

You should attend this seminar if you are responsible for planning, executing or
managing the implementation of any system governed by FDA regulations that uses
ER/ES capability, or if you are maintaining or supporting such a system.

Effective and compliant computer system validation is critical to any
pharmaceutical or FDA-regulated organization.  During the past 30 years, best
practices that have been developed will ensure that validation activities are
cost-effective while meeting all aspects of FDA compliance.

There is an enormous body of documentation and information available that can be
overwhelming.  This course will provide a condensed overview of the key
practices that deliver the best results by directing the attendees to the most
critical and cost-effective methods, techniques and tools available.



AREA COVERED

 * Learn about 21 CFR Part 11 and what is required for compliance
 * Learn about industry best practices related to compliance and computer system
   validation
 * Understand strategies for reducing the cost and complexity of compliance with
   FDA regulations, including 21 CFR Part 11
 * Understand how the System Development Life Cycle (SDLC) methodology supports
   the computer system validation process
 * Understand how to effectively document the process of computer system
   validation, and maintain current information about the various systems in
   your organization and how they are maintained in a validated state
 * Learn how to gain information about trends in validation, as industry
   progresses and new best practices emerge
 * Understand some of the industry best practices and FDA inspection trends that
   will help you to achieve 21 CFR Part 11 compliance
 * Q&A



LEARNING OBJECTIVES

Upon completion of this session, attendees will have an understanding of how to:

 * The activities and investments to support corporate drivers, strategies and
   compliance
 * Establish 21 CFR Part 11 program compliance, including objectives,
   decision-making organizational structures and assigned roles and
   responsibilities that fit within the organizational culture
 * Understand the role of data owners vs. data stewards
 * Understand the criticality of data identity, trust, security, integrity,
   accessibility, reliability and consistency
 * Design data governance processes that encompass people, processes and
   technology
 * Understand the policies and procedures necessary to support the data
   governance framework



WHO WILL BENEFIT?

 * Information Technology Analysts
 * Information Technology Developers and Testers
 * QC/QA Managers and Analysts
 * Analytical Chemists
 * Laboratory Managers
 * Automation Analysts
 * Manufacturing Supervisors and other Key Personnel
 * Warehouse and Supply Chain Supervisors and Other Key Personnel
 * Computer System Validation Specialists
 * GMP Training Specialists
 * Business Stakeholders/Subject Matter Experts
 * Business System/Application Testers
 * Clinical Data Managers and Scientists
 * Quality Managers, Chemists and Microbiologists
 * Regulatory Affairs Personnel
 * Consultants in the Life Sciences and Tobacco Industries

Anyone who is involved in the development, testing, manufacturing, storage,
handling and distribution of product must understand and conform to FDA
requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these
industries should be aware of the requirements for data integrity for their
systems.

You should attend this seminar if you are responsible for planning, executing or
managing the implementation of any system governed by FDA regulations that uses
ER/ES capability, or if you are maintaining or supporting such a system.

Effective and compliant computer system validation is critical to any
pharmaceutical or FDA-regulated organization.  During the past 30 years, best
practices that have been developed will ensure that validation activities are
cost-effective while meeting all aspects of FDA compliance.

There is an enormous body of documentation and information available that can be
overwhelming.  This course will provide a condensed overview of the key
practices that deliver the best results by directing the attendees to the most
critical and cost-effective methods, techniques and tools available.

 * Learn about 21 CFR Part 11 and what is required for compliance
 * Learn about industry best practices related to compliance and computer system
   validation
 * Understand strategies for reducing the cost and complexity of compliance with
   FDA regulations, including 21 CFR Part 11
 * Understand how the System Development Life Cycle (SDLC) methodology supports
   the computer system validation process
 * Understand how to effectively document the process of computer system
   validation, and maintain current information about the various systems in
   your organization and how they are maintained in a validated state
 * Learn how to gain information about trends in validation, as industry
   progresses and new best practices emerge
 * Understand some of the industry best practices and FDA inspection trends that
   will help you to achieve 21 CFR Part 11 compliance
 * Q&A

Upon completion of this session, attendees will have an understanding of how to:

 * The activities and investments to support corporate drivers, strategies and
   compliance
 * Establish 21 CFR Part 11 program compliance, including objectives,
   decision-making organizational structures and assigned roles and
   responsibilities that fit within the organizational culture
 * Understand the role of data owners vs. data stewards
 * Understand the criticality of data identity, trust, security, integrity,
   accessibility, reliability and consistency
 * Design data governance processes that encompass people, processes and
   technology
 * Understand the policies and procedures necessary to support the data
   governance framework

 * Information Technology Analysts
 * Information Technology Developers and Testers
 * QC/QA Managers and Analysts
 * Analytical Chemists
 * Laboratory Managers
 * Automation Analysts
 * Manufacturing Supervisors and other Key Personnel
 * Warehouse and Supply Chain Supervisors and Other Key Personnel
 * Computer System Validation Specialists
 * GMP Training Specialists
 * Business Stakeholders/Subject Matter Experts
 * Business System/Application Testers
 * Clinical Data Managers and Scientists
 * Quality Managers, Chemists and Microbiologists
 * Regulatory Affairs Personnel
 * Consultants in the Life Sciences and Tobacco Industries

Anyone who is involved in the development, testing, manufacturing, storage,
handling and distribution of product must understand and conform to FDA
requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these
industries should be aware of the requirements for data integrity for their
systems.


SPEAKER PROFILE

Carolyn Troiano has more than 35 years of experience in computer system
validation in the tobacco, pharmaceutical, medical device and other
FDA-regulated industries. She has worked directly, or on a consulting basis, for
many of the larger pharmaceutical and tobacco companies in the US and Europe.
She is currently building an FDA computer system validation compliance strategy
at a vapor company. Carolyn has participated in industry conferences, and 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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