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28 Sep 2021
through 29 Sep 2021 |
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Compliance Online
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Keywords:
Event description:
Through a wide variety of regulations, standards, and guidance, the U.S. FDA and other global regulatory competent authorities are increasingly focused on software used for numerous regulated purposes. Such uses include the management and analysis of clinical studies, product development, manufacturing, and the automation of Quality System elements such as complaint management, CAPA, management review, risk management, and document control. Each system within this scope must have evidence it was validated for its intended use.
With the dual purpose of ensuring regulated software contributes to product safety and efficacy and of improving organizational compliance, regulatory authorities face not only the ubiquitous incorporation of these systems but increasingly complex technical environments. From their point of view, companies using software for regulated purposes also see a rapidly evolving technical landscape and a maturing regulatory environment, with increased technical com...
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Through a wide variety of regulations, standards, and guidance, the U.S. FDA and other global regulatory competent authorities are increasingly focused on software used for numerous regulated purposes. Such uses include the management and analysis of clinical studies, product development, manufacturing, and the automation of Quality System elements such as complaint management, CAPA, management review, risk management, and document control. Each system within this scope must have evidence it was validated for its intended use.
With the dual purpose of ensuring regulated software contributes to product safety and efficacy and of improving organizational compliance, regulatory authorities face not only the ubiquitous incorporation of these systems but increasingly complex technical environments. From their point of view, companies using software for regulated purposes also see a rapidly evolving technical landscape and a maturing regulatory environment, with increased technical competence on the part of interested third parties. The confluence of these two perspectives places burden on both parties to “up their game” in terms of relevant regulatory frameworks, process discipline, and technical ability.
Learning Objectives:
Understand the difference between regulated and unregulated software in life sciences industries
Identify the major global regulatory documents governing regulated software
Become familiar with basic terms associated with regulated software and how they may differ from terms in other industries
Understand the objectives of global regulatory bodies in their oversight of regulated software
Understand the activities and elements of various regulated software lifecycle models
Identify required and recommended documentation to ensure defensible evidence of validation for intended use
Understand how to do effective impact analysis of changes to the software system
Understand the obligations of firms using software developed by third parties
Understand the obligations of firms using software hosted by third parties
Understand the importance of confidentiality, integrity, and availability (i.e. CIA) in the software lifecycle
Understand the importance of 21 CFR Part 11 to the software lifecycle and why it is often mistaken for the sum total of validation requirements
Areas Covered:
Current regulatory landscape (regulations, standards, guidance)
Basic terminology and concepts of regulated software lifecycles
Activity and documentation requirements
Change management
Cloud-hosted systems
Software-as-a-Service (SaaS)
Cybersecurity
Who will benefit:
Regulatory Affairs Staff
Quality Assurance Staff
Managers
Directors
VPs
IT Managers
Manufacturing Managers
Clinical Affairs Staff
Software Vendors and Suppliers
Posting date:
22 August 2021 |
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