BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T090616Z UID:fc66b731-3953-41e2-9ba6-12f254f4e373 DTSTART:20210625T090000 DTEND:20210626T090000 CLASS:PRIVATE DESCRIPTION:
This Seminar will focus on the key are as that are most important for protecting the validity of data that is reg ulated by FDA\, and is typically housed electronically in computer systems . This includes how to properly validate an FDA-regulated computer system in order to ensure security and data integrity objectives are met. Impleme nting and following the System Development Life Cycle (SDLC) methodology i s the best approach for Computer System Validation (CSV) and maintaining t he system in a validated state throughout its life.
\n\nThe SDLC app roach takes all aspects of validation into account throughout the life of the system and protects the data that it houses through its retention peri od. The data is a key asset for any FDA-regulated company and must be prot ected. If data becomes invalid\, based on improperly validating and mainta ining the system that houses it in a validated state\, the work related to the data would need to be repeated. This could result in a devastating lo ss to any company'\;s bottom line.
\n\nWe will discuss the key ar eas that are most important during inspection and audit\, including securi ty\, data integrity\, validation\, training\, and documentation.
\n\nFDA requires that all computer systems that handle data regulated by the Agency be validated in accordan ce with their guidance on computerized systems. This guidance was first is sued in 1983\, and the main points of focus remain consistent today\, desp ite the number of years that have passed and the technology changes that h ave taken place.
\n\nThe guidance was revisited for its application to the medical device industry in the 1990s\, as the first issuance addres sed pharmaceuticals only. In 1997\, 21 CFR Part 11 was issued to address e lectronic records and signatures\, as many FDA-regulated organizations beg an seeking ways to move into a paperless environment. This guidance has be en modified over the years to make it more palatable to industry\, and thi s includes discretionary enforcement measures\, but still remains somewhat confusing. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing th e technology.
\n\nThis session will provide some insight into curren t trends in compliance and FDA enforcement. Some are based on technology c hanges\, and these will continue to have an impact as new innovations come into use in the industry. Others are based on factors including economics \, social media\, new diseases\, politics\, and a host of other influences .
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