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 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.

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