Regulated by FDA 2017 - Best Validation Practices for Laboratory Computer Systems Regulated by FDA
Venue2754 80th Avenue, New Hyde Park, NY 11040, USA - United States
Keywords21 cfr compliance; 21 cfr part 11 compliance; Cfr 21 part 11 compliance
Topics/Call fo Papers
We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done.
In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.
Why Should You Attend
You should attend this webinar if you are responsible for planning, executing or validating a laboratory computer system, or managing the system in a validated state through the end of the system life cycle. The webinar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.
The webinar will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.
All aspects of the work will be covered, including roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will also learn what is required not only to validate your laboratory system, but also to maintain it in a validated state until it is retired or otherwise no longer in use.
Areas Covered in this Webinar
System Development Life Cycle (SDLC) Methodology
Computer System Validation (CSV)
Good “Variable” Practice (GxP)
Good Manufacturing Practice (GMP)
Good Laboratory Practice (GLP)
GAMP 5 Guidance for System Classification
Risk Assessment and Management
Change Control and Audit Trails
User Requirements Specification (URS) & Functional
Requirements Specification (FRS)
System Design Specification (SDS) and System
Configuration Specification (SCS)
Test Planning, Execution and Documentation (IQ/OQ/PQ)
Requirements Traceability Matrix (RTM)
System Acceptance, Release Notification and Deployment
Data Governance Archival
Upon completion of this session, attendees will:
understand laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework
receive guidance on industry best practices necessary to develop an compliant and cost-effective validation program
understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
have a good grasp of how to leverage best industry practices across all systems by creating a standardized computer system validation program
Who Will Benefit
Professionals in the following industries:
Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Professionals in the following subject areas:
Information technology managers and analysts
QC/QA managers and analysts
Clinical data managers and scientists
Lab managers and staff
Computer system validation specialists
GMP training specialists
Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
For more detail please click on this below link:
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Last modified: 2017-05-19 16:40:00