🎤  Carolyn Troiano        |  📅  May 8, 2024    |  🕒  11 AM Eastern Time US 


SEMINAR AGENDA:

  • Learn how to identify “GxP” Systems
  • Discuss the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
  • Learn about cloud service and SaaS providers and the best approach for conducting a vendor audit and performing Installation Qualification (IQ) for validation
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Understand how to maintain a system in a validated state through the system’s entire life cycle
  • Learn how to assure the integrity of data that supports GxP work
  • Discuss the importance of “GxP” documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences that lead to FDA’s current thinking at any given time
  • Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
  • Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
  • Learn how to best prepare for an FDA inspection or audit of a GxP computer system
  • Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle




Description:

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.  These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.  All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities anddetermining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work.

Area Covered In The Session:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance. 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
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. 


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