BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T012317Z
UID:0536942d-bb71-49ef-8eb8-be3a09a0cb92
DTSTART:20201216T080000
DTEND:20201217T080000
CLASS:PRIVATE
DESCRIPTION:Course &ldquo\;Computer systems Validation (CSV) for Excel Spre
adsheets&ldquo\; has been Pre-approved by RAPS as eligible for up to 12 cr
edits towards a participant'\;s RAC recertification upon full completio
n.
\n \;\n
Spreadsheets such as Excel\, are available for creat ing a wide range of end user applications\, including widespread use in th e laboratory\, creating customized statistical analyses\, the creation of local databases\, data mining\, and multivariate analysis. These may be us ed for GxP regulated activities\, and they present particular compliance c hallenges\, as Excel and other spreadsheets are not originally designed fo r the regulated environment.
\n\nGxP records generated by spreadshee t calculations are electronic records and should comply with FDA&rsquo\;s 21 CFR Part 11 and the European Annex 11. For critical records Part 11 con trols\, such as data accuracy and data integrity\, should be implemented. Currently there are no specific industry FDA guidelines on using spreadshe ets in regulated environments. However\, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study\, or lab oratory or manufacturing data.
\n\nThis makes spreadsheets a very po werful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much t raining. However\, this has resulted in spreadsheets being among the most under-documented systems used in GxP environments because:
\n\n 
\;  \;  \;  \; &bull\; \;  \;  \;  \;users reg
ard them as part of the desktop
\n \;  \;  \;  \; &bu
ll\; \;  \;  \;  \;the ease with which applications can be
built without much training
\n \;  \;  \;  \; &bull\
; \;  \;  \;  \;the data processing power that they can ha
ve
\n \;  \;  \;  \; &bull\; \;  \;  \; &
nbsp\;lack of knowledge that spreadsheets need to be validated
\n&nbs
p\;  \;  \;  \; &bull\; \;  \;  \;  \;lack of
knowledge on how to validate spreadsheets
Consequently\, Spreads heets have become &ldquo\;low hanging fruit&rdquo\; during FDA or other re gulatory inspections and many warning letters have been issued. \;
\n\nPart 11 / Annex 11 Computer Systems Valid ation (CSV) is be implemented in order to increase the integrity\, account ability and security of the spreadsheets and achieve GxP Compliance. CSV e nables the level and rigor of specification and verification applied to sp readsheets to be based on spreadsheet risk\, complexity\, and novelty. Thi s hands-on seminar will provide the attendees with the tools for successfu l computer systems validation for Excel Spreadsheets. It will address the following topics:
\n\n1. \;  \;Types and Uses of Excel Sprea
dsheets (e.g. disposable spreadsheets\, spreadsheets used as documents\, e
tc.)
\n2. \;  \;Risk Based Approach and Controls to Excel Spr
eadsheets (incl. Excel specific risks)
\n3. \;  \;Computer Sy
stems Validation for Excel (will cover 21 CFR 11\, Annex 11)
\n4.&nbs
p\;  \;The FDA&rsquo\;s Perspective and Use of Spreadsheets
\n5.&
nbsp\;  \;Examples of Typical Approaches for Excel Validation
\n6
. \;  \;How to tailor your risk based methodology to Excel to dete
rmine the level of validation required
\n7. \;  \;483s and Wa
rning Letters for Excel and other Spreadsheets
\n8. \;  \;Qui
z: Test your understanding of Computer Systems Validation for Excel
&bull\; \;  \;  \; VP of IT\n&bull\; \;  \;  \; Director of IT
\n&bull\; \;
 \;  \; Quality Managers
\n&bull\; \;  \;  \; Pro
ject Managers (for CSV / IT)
\n&bull\; \;  \;  \; Validat
ion Specialists
\n&bull\; \;  \;  \; Database Administrat
ors
\n&bull\; \;  \;  \; System Administrators
\n&bu
ll\; \;  \;  \; Directors / Senior Directors of Discovery
\n&bull\; \;  \;  \; Directors / Senior Directors of Developm
ent
\n&bull\; \;  \;  \; Directors / Senior Directors of
Commercialization
\n&bull\; \;  \;  \; Document Managers<
br />\n&bull\; \;  \;  \; Training Managers
\n&bull\;&nbs
p\;  \;  \; Regulators
T
his 2 Days Workshop is intended for professionals in the \;
\n&bu
ll\; \; Pharmaceuticals
\n&bull\; \; Biotech
\n&bull\;&n
bsp\; Medical Device
\n&bull\; \; Radiological Health
\n&bul
l\; \; Blood Products
\n&bull\; \; Companion Animals
\n&
bull\; \; Food
\n&bull\; \; Cosmetics
\n&bull\; \; T
obacco
\n&bull\; \; Academia Industry. Although not presently sta
ted in the draft \, the same guide could be used by FDA Regulated Industri
es personnel.