3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know

With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative in CSA), there was a need for adaptations after 14 years. These adaptations have now been integrated into the 2nd Edition, which has been available. The publication of a 2nd Edition instead of a completely new GAMP®6 shows that the basic principles of GAMP®5 are still relevant. In the 2nd Edition, changes and further developments have been made according to the motto evolution instead of revolution.

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 latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.

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.

Seminar Agenda:

• Learn how to identify “GxP” Systems
• GAMP®5 Second Edition – What’s Different – What’s New?
• Understand GAMP®5 (Second Edition) and the best practices that will impact your validation work
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Learn how to assure the integrity of data that supports GxP work
• 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
• GAMP®5 2nd Edition Impact on System Suppliers

Why You Should Attend:

Verification and validation requirements have always been part of the US FDA’s GMPs.However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, are not documented in a top tier Master Validation Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. 

The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.

Who Should Attend:

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.

Course Director: 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. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.