2020 - 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 21 CFR 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 bal-ance 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 main-taining computer systems in your organization
Understand the best practices for maintaining a computer system with ER/ES capability in a vali-dated state
Discuss the best practices necessary to ensure all systems with ER/ES capability are validated ap-propriately
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 implemen-tation, 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 valida-tion 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.
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http://bit.ly/32K8Tnn
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