Trends of 2020 related to 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Sys-tems Regulated by FDA
Pharmaceuticals
and other FDA regulated industries need to ensure that electronic
record/electronic signature (ER/ES) capability built into
FDA-regulated computer systems meets compliance with FDA 21 CFR Part 11.
Our upcoming webinar discusses how to plan, execute or manage the
implementation of any system governed by FDA regulations that uses ER/ES
capability using cost-effective methods, techniques and tools.
The
webinar covers the following key areas:
·
Gain an understanding of FDA’s 21CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance
document
·
Understand how to effectively document
the process of computer system validation where ER/ES capability exists, and
maintain current information about the various systems in your organization
·
Learn how to develop the appropriate
computer validation strategy, to ensure a good balance of cost vs. risk, as it
applies to the use of ER/ES capability
LEARNING
OBJECTIVES
Gain an understanding of FDA’s 21 CFR Part 11
Electronic Records/Electronic Signatures (ER/ES) guidance document
Develop the ability to apply 21 CFR Part 11
regulations when implementing, validating and maintaining computer systems in
your organization
Understand the best practices for maintaining
a computer system with ER/ES capability in a validated state
Discuss the best practices necessary to ensure
all systems with ER/ES capability are validated appropriately
Learn how to develop the appropriate computer
validation strategy, to ensure a good balance of cost vs. risk, as it applies
to the use of ER/ES capability
Understand how to effectively document the
process of computer system validation where ER/ES capability exists, 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
ER/ES validation, as industry progresses and new best practices emerge
Understand some of the key “pitfalls” to avoid
when employing ER/ES capability
Q&A
WHO
WILL BENEFIT
Information Technology Analysts
QC/QA Managers
QC/QA Analysts
Clinical Data Managers
Clinical Data Scientists
Analytical Chemists
Compliance Managers
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders responsible for computer
system validation planning, execution, reporting, compliance, maintenance and
audit
Consultants working in the life sciences
industry who are involved in computer system implementation, validation and
compliance
Auditors engaged in the internal inspection of
labeling records and practices
All FDA-regulated industries:
Pharmaceutical
Biologicals
Medical Device
Tobacco
Speaker
Profile:Carolyn
Troiano has more than 30 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.
Use Promo Code SPRS20 and
get flat 20% discount on all purchases.
To Register (or) for more details
please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Check out our popular webinars:
1.
3 Hour Excel Automation Boot Camp: Pivot Tables, Top 10 Functions &
Formulas, Basics of Macros and VBA - http://bit.ly/39hfVTa
2.
Improving Employee Engagement through Structured Mentoring - http://bit.ly/2QvVk6I
Comments
Post a Comment