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

Duration : 90 Minutes

Carolyn Troiano,

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. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. Du Read more

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.  This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability, in order to achieve a goal of going “paperless”.  Workflow is key and will be addressed during the webinar.

Course Objectives:

• 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 how to build a workflow to reduce the amount of paper and manual processes involved in your operations
• Understand the benefits and challenges of moving to a paperless environment
• 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 to apply when following the SDLC methodology

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.

In particular, with 21 CFR Part 11, automated workflows can reduce manual effort and cost, but come at the price of ensuring 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.

Course Outline:

• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation Strategy that will take into account the system risk assessment process
• FDA’s 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
• How to build a workflow application that will meet FDA compliance, including decisions to make based on benefit and risk
• Strategic Approach to ER/ES Compliance
• Policies and Procedures to support GxP compliance with 21 CFR Part 11
• Training and Organizational Change Management best practices to help move the organization in a new direction
• Industry best practices and common pitfalls

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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