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
Biotechnology
Medical/Healthcare/Hospital
Location
Aurora, Colorado, United States
OVERVIEW
This webinar will take you through the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV), focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance.
This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process.
WHY SHOULD YOU ATTEND
You should attend this webinar to learn about:
- Computer System Validation (CSV) approach.
- Using the System Development Life Cycle (SDLC) methodology to support CSV efforts.
- CSV and SDLC deliverables that must be documented properly to comply with FDA requirements.
- A deeper dive into the Functional Requirements Specification (FRS) deliverable, a key document to support the CSV effort.
- Policies, procedures, training, and organizational change management that are all key aspects of a successful CSV effort and developing detailed and thorough requirements.
- Industry best practices related to CSV and the SDLC methodology, as well as for delivering solid requirements.
- Common findings of FDA related to CSV during computer system inspection and audit that can be avoided by following best practices to develop solid requirements as part of the effort.
AREAS COVERED
- Requirements for Computer System Validation (CSV) in compliance with FDA.
- Applying a strategic approach to CSV for FDA compliance.
- Using the System Development Life Cycle (SDLC) methodology to support CSV.
- CSV strategic planning, execution, and documentation.
- Detailed analysis of the Functional Requirements Specification (FRS), a key deliverable for the CSV effort.
- Policies and procedures to support the CSV effort and your requirements.
- Training and organizational change management best practices to support CSV and development of detailed and thorough requirements for testing.
- Preparing your computer system documentation for an FDA inspection.
- Q&A
LEARNING OBJECTIVES
- We will provide an overview of FDA’s guidelines as they pertain to computer system validation of GxP systems used in manufacturing, marketing, distribution and other operational activities engaged by companies in FDA-regulated industries.
- We will describe the System Development Life Cycle (SDLC) methodology and how to apply it to Computer System Validation (CSV) work.
- We will review the SDLC deliverables key to a successful CSV effort.
- We will take a deeper dive into the Functional Requirements Specification (FRS) process and documentation to support a successful CSV effort.
- This course will describe the best practices for developing detailed and thorough FDA system validation requirements, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.
- We will provide specific guidance on industry best practices for delivering solid requirements that will meet FDA compliance.
WHO WILL BENEFIT
This webinar will provide valuable assistance to all personnel in:
- Data “Owners”
- Data “Stewards”
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Consultants working in the life sciences industry who are involved in the validation of computer systems.
For more detail please click on this below link:
https://bit.ly/2Bn14r8
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Others Details
Learn about the FDA system validation requirements and how to ensure FDA compliance. Also learn about the fundamentals of System Development Life Cycle (SDLC)
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
Pin/Zip Code : 80016-6104