BEGIN:VCALENDAR
PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN
VERSION:2.0
BEGIN:VEVENT
DESCRIPTION:This highly interactive two-day course uses real life examples
  and explores proven techniques for reducing costs\, usually by two-third
 s\, associated with implementing\, and maintaining computer systems in re
 gulated environments.\n\n\nIt details the requirements for Part 11 and An
 nex 11: SOPs\, software product features\, infrastructure qualification\,
  and validation.\nThe instructor addresses the latest computer system ind
 ustry standards for data security\, data transfer\, audit trails\, electr
 onic records and signatures\, software validation\, and computer system v
 alidation.\nUnderstand the specific requirements associated with local an
 d SaaS/cloud hosting solutions.\nNearly every computerized system used in
  laboratory\, clinical\, manufacturing settings and in the quality proces
 s has to be validated. Participants learn how to decrease software implem
 entation times and lower costs using a 10-step risk-based approach to com
 puter system validation.\nThe instructor reviews recent FDA inspection tr
 ends and discusses how to streamline document authoring\, revision\, revi
 ew\, and approval.\nParticipants will learn how to write a Data Privacy S
 tatement to comply with the EU General Data Protection Regulation (GDPR).
 \nThis course benefits anyone that uses computer systems to perform their
  job functions and is ideal for professionals working in the health care\
 , clinical trial\, bio-pharmaceutical\, and medical device sectors. It is
  essential for software vendors\, auditors\, and quality staff involved i
 n GxP applications.&nbsp\;\n\nLearning Objectives:\n\nReduce costs\, usua
 lly by two-thirds\, for compliance with electronic records\nLearn how to 
 use electronic records and electronic signatures to maximize productivity
 \nUnderstand what is expected in Part 11 and Annex 11 inspections so you 
 are prepared\nAvoid 483 and Warning Letters\nUnderstand the responsibilit
 ies and specific duties of your staff including IT and QA\nUnderstand you
 r responsibilities and liabilities when using SaaS/cloud\nLearn how to pe
 rform risk-based Computer System Validation using fill-in-the-blank templ
 ates\nHow to select resources and manage validation projects\n"Right size
 " change control methods that allows quick and safe system evolution\nMin
 imize validation documentation to reduce costs without increasing regulat
 ory or business risk\nLearn how to reduce testing time and write test cas
 es that trace to elements of risk management\nLearn how to comply with th
 e requirements for data privacy\nLearn how to buy COTS software and quali
 fy vendors\nProtect intellectual property and keep electronic records saf
 e\n\nWho will Benefit:\n\nGMP\, GCP\, GLP\, regulatory professionals\nQA/
 QC\nIT\nAuditors\nManagers and directors\nSoftware vendors\, SaaS hosting
  providers\n
DTEND:20260205T030000
DTSTAMP:20260514T153457Z
DTSTART:20260204T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:This highly interactive two-day course uses real life examples and
  explores proven techniques for reducing costs\, usually by two-thirds\, 
 associated...
UID:ee1d077d-f712-46b5-8318-337b8599b5fd
END:VEVENT
END:VCALENDAR