2 Day Online Course: Introduction to Computer System Validation (March 27-28, 2023)
DUBLIN, Jan. 24, 2023 /PRNewswire/ -- The "Introduction to Computer System Validation" training has been added to ResearchAndMarkets.com's offering.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11.This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.
In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company's approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining 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'll talk about CSA and how to validate cloud, COTS, SaaS, and other systems and maintain them in a validated state. This will include a discussion around waterfall, agile, and other methodologies for system development, testing, and validation, including how to apply automated testing to your approach.
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.
CSV Training Overview
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.It is a risk-based approach to Computer System Validation (CSV) and maintenance of a system in a validated state that leads to the best results and compliance with FDA's expectations.
Why Should You Attend
This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do, and a key element is a thorough risk assessment.
It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception throug retirement, making it critical to continue assessing risk as changes are made. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
We will also cover the recent draft guidance from FDA on Computer Software Assurance (CSA), which is based on critical thinking in approach. We'll talk about agile vs. waterfall, automated testing, Cloud, COTS, and Software-as-a-Service. We'll also touch on 21 CFR Part 11, FDA's guidance on electronic records/signatures to discuss the importance of including aspects of er/es technology during validation and maintenance of a system.
01:00pm - 02:00pm:
Module 1:CSV Methods and Models
Module 2:Software and Services
2:00pm-2:10pm - 10 min Break
Module 3: CSV Planning
Module 4:System Requirements and Design
3:50pm-4:00pm - Q&A
Module 5:IQ, OQ, PQ Test Planning & Execution
Module 6:Test and Validation Reports
Module 7: CSV Operations and Maintenance
Module 8:CSV Supporting Components
Module 9:Managing FDA-Regulated Data
Module 10: Vendor Audit
Module 11:FDA Trends
Module 12:Inspection Preparation
4:50pm-5:00pm - Q&A
Additional material that can be read through and completed off-line after the presentation is completed:
For more information about this training visit https://www.researchandmarkets.com/r/62qkrt
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