BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Eventin//Event Calendar//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
BEGIN:VEVENT
UID:0cfea3462933c0dc88fcab55cf7ced99@mivado.com
SUMMARY:Implementing the Computer Software Assurance (CSA): Risk-based appr
 oach
DESCRIPTION:Implementing the Computer Software Assurance (CSA): A Risk-base
 d approach\n\nTransitioning to the new guidance will require unlearning “
 the old” and relearning how to apply Computer Software Assurance (CSA). T
 he emphasis is on critical thinking\, risk management\, patient and product
  safety\, data integrity\, and quality assurance. Even though this guidance
  is being developed for the medical device industry\, the FDA has indicated
  it should be considered when deploying non-product\, manufacturing\, opera
 tions\, and quality system software solutions\, such as quality management 
 systems (QMS)\, enterprise resource planning (ERP) systems\, laboratory inf
 ormation management systems (LIMS)\, learning management systems (LMS)\, an
 d electronic document management systems (eDMS). As such\, the guidance wil
 l apply to research and development (R&D)\, clinical\, laboratory\, and oth
 er groups within pharmaceutical\, biopharmaceutical\, and medical device co
 mpanies that are currently meeting the regulations for electronic records a
 nd electronic signatures (ERES) and computer system validation (CSV).\n\nWh
 y should you attend\n\nThis training will give you a foundation for underst
 anding the guidance\, whether (and how) it is right for you\, and steps to 
 assess its benefits and apply it. This session will provide definitions of 
 critical thinking\, risk management\, patient and product safety\, data int
 egrity\, and quality assurance. Also\, it will focus on transitioning from 
 CSV to CSA by leveraging CSV methodology\, business processes\, and risk ma
 nagement.\n\nIn addition\, the FDA believes that applying a risk-based appr
 oach to computer software used as part of medical device production or the 
 quality system would better focus manufacturers' assurance activities to he
 lp ensure product quality while helping to fulfill the validation requireme
 nts of 21 CFR Part 820.70(i).\n\nWho should attend\n\nThis course will be o
 f benefit to anyone working in a regulated environment who is part of the t
 eam that performs\, reviews\, and approves Manufacturing\, Operations\, and
  Quality Systems Software\, as well as non-product manufacturing\, operatio
 ns\, and quality system software solutions. This includes personnel in:\n\n
 \nClinical Operations\nEngineering & Maintenance\nInformation Technology\nL
 egal Counsel\nManufacturing & Operation\nSupply Chain\; logistic & Distribu
 tion\nQuality & Validation\nRegulatory Affairs\n\n\n\n\n\n\n\n\n\n\n\n\n\n\
 n\n\nLearning objectives\n\nAfter this session\, you will be able to:\n\n\n
 Explain the differences between CSV and CSA\, and the short- and long-term 
 benefits of moving to CSA\nDefine and discuss key terms and concepts being 
 introduced with CSA\, including critical thinking and risk management\nDefi
 ne and discuss patient and product safety\, data integrity\, and quality as
 surance\nIdentify\, categorize\, and classify a system's intended use and c
 lassify software failure risks\nBuild foundational knowledge required to tr
 ansition from CSV to CSA\nProvide an approach to plan for CSA transition to
  include people\, process\, technology\,y and product\nDevelop quality metr
 ics (qualitative and quantitative) on organizational performance: people\, 
 process\, project\,t and technology\nCreate a Transition Plan – with a ph
 ased road map for a successful transition to CSA\nMaintain the system in a 
 validated state \n\n\n\n\n\n\n\n\n\n\n\n\n\n\nEducation approach\n\n\nLect
 ure sessions are illustrated with examples based on case studies\nPractical
  exercises include examples and discussions\n\n\nSpeaker\n\nKossi Molley\, 
 Chemist\; LSSBB\; PMP\, Certified Trainer
LOCATION:Online
DTSTAMP:20260926T223519Z
DTSTART:20261014T130000Z
DTEND:20261014T200000Z
END:VEVENT
END:VCALENDAR