OVERVIEW
We will discuss in detail how computer system validation can be applied to mobile applications 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.

Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.

As technology changes, we need to adapt our approach to computer system validation for systems regulated by FDA to ensure that we take into account all controls that need to be in place, whether technical or procedural. Mobile devices have the added complexity of being small, portable and vulnerable to both physical and logical mishap or calculated attack.

WHY SHOULD YOU ATTEND?
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit.

LEARNING OBJECTIVES
Gain an understanding of how mobile applications should be handled when performing validation work
Understand the best practices for maintaining a mobile application in a validated state
Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications
Q&A

AREAS COVERED
We will detail the key areas of focus, including security, access and change control, along with the documentation that is required to create a complete and compliant validation package in a cost-effective manner.

Computer System Validation (CSV)
Computer Software Assurance (CSA)
Risk Assessment and Mitigation
Validation Strategy and Planning
Requirements and Testing for Validation
Mobile Applications
Security and Access
Change Control
Industry Best Practices

WHO WILL BENEFIT?
Personnel in the following roles 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 labelling records and practices

DATES & VENUE
24 Feb 2023, 1:00 pm - 2:30 pm
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OTHER INFORMATION
Go to Event Website
TOPICS | CATEGORIES






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