www.eventura.site Open in urlscan Pro
54.156.84.168  Public Scan

Form analysis
0 forms found in the DOM

Text Content

Eventura World
 * Eventura World
 * Courses
 * Blogs

 *  
 *  

 
Eventura World
 *  
 *  

   
 * Eventura World
 * Courses
 * Blogs

 1. Eventura World
 2. Courses
 3. A Risk Based Approach to It Infrastructure Qualification, Compliance &
    Control


A RISK BASED APPROACH TO IT INFRASTRUCTURE QUALIFICATION, COMPLIANCE & CONTROL

--------------------------------------------------------------------------------



🎤  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. 






--------------------------------------------------------------------------------

Qualification


Successful Change Control Management
Compliance Audit Enhancement Using Principles Of Lean Documents And Lean
Configuration
Human Factors Engineering Principles For Combination Products

Eventura World
Copyright © 2024 All rights reserved
Powered By SITE123 - Website maker
 * Eventura World
 * Courses
 * Blogs
 * MEMBERSHIP PROGRAMS