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

Thursday, 11 July 2019 10:00 AM PDT, 01:00 PM EDT

Training Duration = 60 min                  Sponsored by Online Compliance Panel

Click Here to register $229.00

Click Here to register and receive CD recording $329.00

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".

Objectives of the Presentation:

  • 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 to apply when following the SDLC methodology

Why Should You Attend:

You should attend this webinar 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.

Areas Covered:

  • 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
  • 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

Instructor Profile:

Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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, developing and executing compliance strategies and programs.