BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T165359Z
UID:4a1c0e30-0b05-429f-9878-72fa6ff4d31e
DTSTART:20210311T090000
DTEND:20210312T090000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nAttendees will be presented with an overview o
f the audit trails within an application and the content of each one\, Als
o Attendees will be presented with a list of records to identify if they a
re GMP records.
\n
\nWhy should you Attend:
\nThe regulator
y concern has been responded to by both domestic and foreign governing age
ncies with the FDA\, EMA\, MHRA\, WHO\, and PIC/S all having recently publ
ished data integrity standards and guidelines.
\n
\nAreas Covere
d in the Session:
\nFile format
\nStorage media
\nEncryptio
n
\nUser management (access control)
\nReview of the data life c
ycle
\nHandling of raw data
\nUnauthorized access
\n
\
nWho Will Benefit:
\nProduction
\nEngineering &\; Validation<
br />\nFacilities / Maintenance
\nQuality Assurance
\nRegulatory
Affairs
\n
\nSpeaker Profile:
\nKelly Thomas has over two
decades of cGMP hands-on industry experience in both pharmaceutical and me
dical device manufacturing operations. Her experience covers all Quality S
ystems\; as well as\, all areas of validation\; including\, process/produc
t validation\, facilities validation\, CSV and 21 CFR Part 11\, test metho
d validation\, equipment/automated processes and cleaning validation.
\n
\nEvent Fee: One Dial-in One Attendee Price: US$150.00
\n
\nContact Detail:
\nCompliance4All DBA NetZealous\,
\nPhone:
+1-800-447-9407
\nEmail: compliance4all14@gmail.com\n