Description 

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing or tracking processes).  Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.

It is important to be able to identify computer systems used when performing FDA-regulated activities.  When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system or maintaining it, this must be done in compliance with FDA requirements.  A solid computer system validation strategy, along with an understanding of industry best practices, will lead your company to ensure that vendors are held accountable for delivery of systems and services that will support your efforts to validate computer systems and maintain them in a validated state.

This webinar will also provide guidance on the importance of factoring risk into all FDA-regulated activities, and will help you assess the risk of any computer products purchased from third-party vendors.  You will also learn how to develop a standard audit process, using templates and checklists, to ease the burden of this activity.  Documentation is critical to proving that a system does what it purports to do, and that a company has thoroughly scrutinized and effectively leveraged any third-party vendor that is involved in these efforts.

We will cover Computer Off-the-Shelf (COTS) software applications, cloud computing, and Software-as-a-Service (SaaS). We’ll discuss the traditional approach to Computer Software Validation (CSV), and contrast it with FDA’s recent draft guidance (September 2022) on Computer Software Assurance (CSA). CSA focuses on critical thinking and a risk-based approach. It also lends itself well to automated testing, and is aligned closely with GAMP®5, Second Edition.

Overall, we’ll discuss the industry best practices and note the pitfalls to avoid when validating systems regulated by FDA.

Areas Covered in the Session:

·        Vendor Audit

·        Vendor Questionnaire

·        Audit Procedure

·        Audit Checklist

·        Leveraging Vendors

·        Vendor Management

·        FDA GxPs

·        Computer System Validation (CSV) Methodology

·        Computer Software Assurance (CSA) Methodology

·        System Development Life Cycle (SDLC) Framework

·        Critical Thinking

·        Risk Management

·        GAMP®5, Second Edition (Good Automated Manufacturing Practice)

·        Automated Testing

·        Waterfall Methodology

·        Agile Methodology

·        Compliance Strategy

·        Cloud-Based Vendors & Validation

·        Software-as-a-Service (SaaS) Vendors & Validation

·        Infrastructure-as-a-Service (IaaS)

·        Platform-as-a-Service (PaaS)

·        Cost vs. Compliance

·        Industry Best Practices

·        Policies and Procedures

·        Training

Why You Should Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco.  Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and 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 computer system governed by FDA regulations, or if you are developing, configuring, maintaining or supporting such a system.

Target Audience

·        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

·        Risk Management Professionals

·        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.