- TypeWebinar
- Location Online Event
- Date 24-02-2023
Administration/Management
Information Technology
Computer/Technology
Medical/Healthcare/Hospital
OTHERS
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
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.
WHO WILL BENEFIT?
Personnel in the following roles will benefit: