BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T005325Z
UID:b5e1aa17-94b6-46c3-b308-dd3dc0a19b65
DTSTART:20201216T080000
DTEND:20201217T080000
CLASS:PRIVATE
DESCRIPTION:
\n&nb
sp\;\n
Course &ldquo\;Computer systems Validation (CSV) for Excel Sprea dsheets&ldquo\; has been Pre-approved by RAPS as eligible for up to 12 cre dits towards a participant'\;s RAC recertification upon full completion .
\n"\;Each attendee will rece ive 2-Day workshop materials \,Certificate\, Complimentary Breakfast \, Lu nch &\; High Tea/Coffee provided by WCS. "\;\n\nSpreadsheets such as Excel\, are available for creati ng a wide range of end user applications\, including widespread use in the laboratory\, creating customized statistical analyses\, the creation of l ocal databases\, data mining\, and multivariate analysis. These may be use d for GxP regulated activities\, and they present particular compliance ch allenges\, as Excel and other spreadsheets are not originally designed for the regulated environment.
\n\nGxP records generated by spreadsheet 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 controls\, such as data accuracy and data integrity\, should be implemented. Currently there are no specific indust ry FDA guidelines on using spreadsheets in regulated environments. However \, the flexibility and power of the spreadsheet allows users to create too ls that range from performing simple calculations to sophisticated analysi s of a major clinical study\, or laboratory or manufacturing data.< /p>\n\n
This makes spreadsheets a very pow erful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much tr aining. However\, this has resulted in spreadsheets being among the most u nder-documented systems used in GxP environments because:
\n\n&bull\; users regard them as part of the de
sktop
\n&bull\; the ease with which applications can be built without
much training
\n&bull\; the data processing power that they can have
\n&bull\; lack of knowledge that spreadsheets need to be validated\n&bull\; lack of knowledge on how to validate spreadsheets
Consequently\, Spreadsheets have beco me &ldquo\;low hanging fruit&rdquo\; during FDA or other regulatory inspec tions and many warning letters have been issued.
\n\nPart 11 / Annex 11 Computer Systems Validation (CSV) is be impl emented in order to increase the integrity\, accountability and security o f the spreadsheets and achieve GxP Compliance. CSV enables the level and r igor of specification and verification applied to spreadsheets to be based on spreadsheet risk\, complexity\, and novelty. This hands-on seminar wil l provide the attendees with the tools for successful computer systems val idation for Excel Spreadsheets. It will address the following topics:
\n\n1. Types and Uses of Excel Spre
adsheets (e.g. disposable spreadsheets\, spreadsheets used as documents\,
etc.)
\n2. Risk Based Approach and Controls to Excel Spreadsheets (in
cl. Excel specific risks)
\n3. Computer Systems Validation for Excel
(will cover 21 CFR 11\, Annex 11)
\n4. The FDA&rsquo\;s Perspective a
nd Use of Spreadsheets
\n5. Examples of Typical Approaches for Excel
Validation
\n6. How to tailor your risk based methodology to Excel to
determine the level of validation required
\n7. 483s and Warning Let
ters for Excel and other Spreadsheets
\n8. Quiz: Test your understand
ing of Computer Systems Validation for Excel
&bull\; VP of IT
\n&bull\; Director of IT
\n&bull\; Qu
ality Managers
\n&bull\; Project Managers (for CSV / IT)
\n&bull
\; Validation Specialists
\n&bull\; Database Administrators
\n&b
ull\; System Administrators
\n&bull\; Directors / Senior Directors of
Discovery
\n&bull\; Directors / Senior Directors of Development
\n&bull\; Directors / Senior Directors of Commercialization
\n&bull\
; Document Managers
\n&bull\; Training Managers
\n&bull\; Regula
tors
This 2 Days Workshop is int
ended for professionals in the \;
\n&bull\; Pharmaceuticals
\n&bull\; Biotech
\n&bull\; Medical Device
\n&bull\; Radiologica
l Health
\n&bull\; Blood Products
\n&bull\; Companion Animals
\n&bull\; Food
\n&bull\; Cosmetics
\n&bull\; Tobacco
\n&
bull\; Academia Industry. Although not presently stated in the draft \, th
e same guide could be used by FDA Regulated Industries personnel.
p>\n
\n \;
SUMMARY:Computer systems Validation (CSV) for Excel Spreadsheets (wcs)
BEGIN:VALARM
ACTION:DISPLAY
TRIGGER:-PT1H
SUMMARY:Computer systems Validation (CSV) for Excel Spreadsheets (wcs)
END:VALARM
END:VEVENT
END:VCALENDAR