Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Education/Teaching/Training/Development
Business Development
Computer/Technology
Biotechnology
Medical/Healthcare/Hospital
Location
Aurora, Colorado, United States
OVERVIEW
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with FDA system validation rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.
The webinar will leave you with the information needed for planning, executing and documenting a computer system validation effort that meets FDA compliance standards. You will learn about the computer system validation requirements and what must be done to ensure the system remains in a validated state.
In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.
WHY SHOULD YOU ATTEND
This webinar 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.
It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. 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.
AREAS COVERED
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Validation Strategy that will take into account the system risk assessment process
- Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
- System Design Specification (SDS) that details how the functional requirements will be delivered
- Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)
- Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
- System Acceptance and Release Notification
- System Retirement steps to close out the life cycle
- Data Archival to ensure security, integrity and compliance
LEARNING OBJECTIVES
- To understand how to create, revise and maintain documentation that is FDA-regulated.
- To understand the many deliverables required to complete a computer system validation effort.
- To understand industry best practices for Computer System Validation.
- To understand and avoid potential pitfalls.
WHO WILL BENEFIT
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
- All FDA-regulated industries:
- Pharmaceutical
- Biologicals
- Medical Device
- Tobacco
For more detail please click on this below link:
https://bit.ly/2SBwikz
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Others Details
Know the fundamentals of Computer System Validation and what the planning and documentation requirements are. The webinar also discusses how to maintain the systems in validated state.
Registration Fees
Available
Registration Fees Details
Live Session
for one participant
$199
Corporate Live Session
Group – Max 10 Participants from one location.
$549
Recorded Session
Get unlimited access to the link for six months.
$219
Training DVD or USB Flash Drive
MP3 files, PDF presentation and reference manual will be delivered on a CD
$399
Super Combo Offer 1
Live and Recorded webinar
$329
Super Combo Offer 2
Live and Training CD
$499
Registration Ways
Email
Phone
Website
Other
Address/Venue
Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016
Pin/Zip Code : 80016