• Data Governance for Computer Systems Regulated by FDA

    3,000.007,000.00

    Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost, complexity and risk associated with maintaining it, and ensure that all FDA compliance requirements are met.

    As decision making is a key area of interest in the regulated world, companies must be able to establish clear rules for managing source data used in critical regulatory decisions. Given the complexity of the data involved, and the compliance requirements mandated by FDA, organizations operating in this environment must have a formal system of governance.

    Organizations continue to be more data-driven, meaning effective data governance is essential to providing trusted, timely, high-quality data consistently to all users. Creating a data governance initiative can be a daunting task, leaving companies feeling overwhelmed, but there are best practices that can get you started quickly down the road to success by providing a framework with the necessary depth, breadth and flexibility to overcome common pitfalls.

    We will discuss the importance of establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations. A data governance framework is a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data. As data governed by FDA must adhere to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable, we will look at ways to leverage these in developing an overall data governance framework and program.

    Areas Covered in the Session :

    • Linking data governance activities and investments to corporate drivers, strategies and compliance
    • Establish data governance program objectives, decision-making organizational structures and assigned roles and responsibilities that fit within the organizational culture
    • Understand the role of data owners vs. data stewards
    • Understand the criticality of data identity, trust, security, integrity, accessibility, reliability and consistency
    • Designing data governance processes that encompass people, processes and technology
    • Understand the policies and procedures necessary to support the data governance framework
    Who Should Attend:

    This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

    You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include::

    • Information Technology Analysts
    • Information Technology Developers and Testers
    • QC/QA Managers and Analysts
    • Analytical Chemists
    • Compliance and Audit Managers
    • Laboratory Managers
    • Automation Analysts
    • Computer System Validation Specialists
    • GMP Training Specialists
    • Business Stakeholders/Subject Matter Experts
    • Business System/Application Testers
    • This webinar will also benefit any consultants working in the life sciences industry who are
      involved in computer system implementation, validation and compliance.
  • FDA Compliance and Laboratory Computer System Validation

    3,000.007,000.00

    You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations.

    Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.

    There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

    Areas Covered in the Session :

    • Gain an understanding of laboratory system computer validation planning, execution and management concepts
    • Discuss the best practices for laboratory computer system validation that will ensure compliant results while minimizing costs
    • Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing
    • Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs
    • Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems
    • Understand the training that must be provided to business and IT staff involved in the validation process
    • Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality
    • Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality
    Who Will Benefit:

    This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

    You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Professionals who will benefit include:

    • Information Technology Analysts
    • Information Technology Developers and Testers
    • QC/QA Managers and Analysts
    • Analytical Chemists
    • Compliance and Audit Managers
    • Laboratory Managers
    • Automation Analysts
    • Computer System Validation Specialists
    • GMP Training Specialists
    • Business Stakeholders/Subject Matter Experts
    • Business System/Application Testers
    • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.