BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T062320Z
UID:9464fd89-f56b-46ec-92df-5c80cdb81da3
DTSTART:20211115T203000
DTEND:20211116T203000
CLASS:PRIVATE
DESCRIPTION:"\;Each attendee will receive 2-Day workshop materi
als by the speaker. Seminar Also Includes Certificate\, Complimentary Brea
kfast\, Lunch &\; High Tea/Coffee provided by WCS"\;
\n
\nData Integrity is a major concern of regulatory agencies worldwi
de as evidenced by the increasing number of Warning Letters issued in that
area. Some managements have proceeded to implement data integrity program
s on the lines of those implemented in &ldquo\;big data&rdquo\;. This has
resulted in the escalation of costs and it is disproportionate to the bene
fits gained. Some even wonder why they continue to receive Warning Letters
in spite of spending the dollars to implement programs such as Data Gover
nance etc. etc.
\n \;\n
What is Data integrity
\n\nData Life Cycle design and controls
\n\nElements of a Data Integrity Assurance program
\n\nRoles and responsibilitie s of different groups in ensuring data integrity
\n\nWhat data integ rity SOPs do auditors expect to see during audits
\n\nValidating Dat a Integrity
\n\n \;
\n\nPharmaceutical industry / Medical device industry / Healthcare in dustry personnel
\n \nDevelopers of software for use in Life Sciences industry
\nValidation service provide rs\, IT service providers
\nManufacturing personnel\ , Manufacturing Automation system vendors and system integrators
\n \nRegulatory Affairs group\, Quality Unit
\nLaboratory personnel
\nUsers of Cloud
\n \nClinical Trial Sponsors
\n
\n Chinmoy Ro
yBSEE\, MSCS US FDA Expert Data integrity &\; CSV