BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T060839Z
UID:1e717481-8789-4d19-8acf-d66ee7ff770d
DTSTART:20210225T133000
DTEND:20210226T133000
CLASS:PRIVATE
DESCRIPTION:Overview
\n
\nData integrity is defi
ned as the maintenance of\, and the assurance of the accuracy and consiste
ncy of\, data over its entire life-cycle. Data Integrity is a global issue
with both FDA and the European Regulatory Agencies majorly focusing on th
e topic during compliance inspections. Multiple FDA warning letters and EU
GMP non-compliance reports have highlighted major data integrity failures
and falsification within companies around the globe. The regulatory conce
rn has been responded to by both domestic and foreign governing agencies w
ith the \;FDA\, EMA\, MHRA\, WHO\, and PIC/S all having recently publi
shed data integrity standards and guidelines.
\nThis webinar will det
ail a data integrity governance program and principles for defining qualit
y and data integrity into processes and systems.\n
Session Highl ights
\n\nTopic 1: Regulatory Guidance Review
\n\n&bull\; FDA (CFR)
\n\n&bull\; EU (EurdraLex)
\n\n&bull\; PIC/S
\n\n \;
\n\nTopic 2: Review all Elements Important to Maintaining Data Integrity
\n\n& bull\; The ALCOA+ criteria for data integrity
\n\n&bull\; Data life cycle in the process workflow &ndash\; managing controls
\n\n&bull\; Paper versus electronic systems
\n\n&bull\; Validation of computeri zed systems for data integrity controls
\n\n \;
\n\n< p>Topic 3: Key Data Integrity Topics\n\n&bull\; Re cording results on paper. Good Documentation Practices
\n\n&bull\; A udit trail
\n\n&bull\; Data review
\n\n&bull\; File format
\n\n&bull\; Storage media
\n\n&bull\; Encryption
\n\n&bull\ ; User management (access control)
\n\n&bull\; Review of the data li fe cycle
\n\n&bull\; Handling of raw data
\n\n&bull\; Unauthor ized access
\n\n&bull\; Appropriate access privileges for each user role
\n\n&bull\; Is my chromatographic system ready? Role of &ldquo\ ;test&rdquo\; injections
\n\n&bull\; Audit trails &ndash\; options f or older systems
\n\n&bull\; Manual chromatographic integration
\ n\n&bull\; Standalone versus network systems
\n\n&bull\; Protecti ng electronic records of standalone systems
\n\n \;
\ n\nTopic 4: What are GMP-relevant Data?
\n\n&bul l\; GMP-relevant data &ndash\; what are GMP-relevant data?
\n\n&bull \; Identifying data that has been changed or modified &ndash\; how the sys tem can help
\n\n&bull\; Review by exception &ndash\; how technical controls can help
\n\n&bull\; Have you specified and validated these functions?
\n\n \;
\n\nTopic 5: Why Is An Audit Trail Review Important?
\n\n&bull\; Suspected data i ntegrity violation - What do we need to do?
\n\n \;
\ n\nTopic 6: Can Spreadsheets meet Data Integrity requirements?< /strong>
\n\n&bull\; Problems with spreadsheets
\n\n&bull\; Go od Practice for using spreadsheets in a regulated environment
\n\nBu ilding data integrity features into a spreadsheet
\n\n \ ;
\n\nTopic 7: Common problems from FDA 483 observations and warning letters and how to avoid them
\n\nCase Stu dy 1: Audit Trail to Review?
\n\n1. Attendees will be prese nted with an overview of the audit trails within an application and the co ntent of each one. Which audit trails should be reviewed and when?
\n\n2. Attendees will be provided with the output of an audit trail to revi ew and see if any potential issues are identified for further investigatio n.
\n\n3. Attendees will be presented with a list of records to iden tify if they are GMP records. Examples from production\, laboratory and QA examples of GMP-relevant data will be provided.
\n\n \;
\n\n \;
\n\nWho will Benefit
\n\n&
bull\; Quality Assurance \;
\n&bull\; Regulatory Affairs
\n&
bull\; Operations Managers
 \;
\n\nUpo n completion of this session\, you will be able to Get:
\n\n&bull\; Live question and answer session
\n
&bull\; Copy of speaker'\;s presentation slides
\n&bull\; Certificate