Spreadsheet Validation: Understanding and Satisfying FDA Requirements
1. Spreadsheet Validation: Understanding and
Satisfying FDA Requirements
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
2. Instructor Profile:
Alfonso Fuller is the President of
Fuller Compliance, Inc., a
consulting firm that specializes in
FDA quality system, software
validation and software quality for
pharmaceutical, biotech and
medical device, nutraceutical and
food manufacturers. He is a
consultant, writer, and frequent
presenter nationwide on quality
system and software quality issues.
His speaking appearances have
included numerous national and
statewide conferences.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
3. Description:
Many companies struggle with spreadsheet
compliance. Some are still using invalidated
spreadsheets. Many companies lack an
understanding of how to satisfy FDA
technical validation requirements as applied
to spreadsheets. Most organizations lack a
clear spreadsheet compliance strategy. An
unplanned 'emergency' spreadsheet
validation project could paralyze the
organization. This webinar will describe
methods for planning and executing
spreadsheet validations that satisfy FDA
requirements.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
4. Objectives of the Presentation:
•Understand the significance of spreadsheets as software as
viewed by US FDA
•Review current FDA posture towards spreadsheets
•Know how to conduct an audit of the use of spreadsheets in
the organization
•Recognize when spreadsheets being used should conform to
FDA regulations
•Be able to determine which spreadsheets are not required
to be validated, and how to document
•Be able to determine which spreadsheets do not trigger 21
CFR part 11 compliance
•Know the relationship between spreadsheets and SDLC
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
5. Areas Covered:
•Review current enforcement posture towards spreadsheets
•Review the relationship between 'validation' and 'part 11
compliance'
•Determining which spreadsheets require validation – and
which don't
•Which spreadsheets are required to be compliant to 21 CFR
Part 11
•Technical issues discussion
•Practical tips on gaining control over spreadsheets
•Practical tips on spreadsheet validation
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
6. Who can Benefit:
•System
Owners -
Responsible for
keeping
individual
systems in
validation
•QA / QC
Managers,
Executives and
Personnel
•IT / IS
Managers and
Personnel
•Validation
Engineers,
Validation
Specialists
•Software
Quality
Reviewers,
Software
Quality
Reviewers, SQA
•Consultants
•Quality
Engineers
•Production
and Process
Engineers
•Manufacturing
Engineers
•Design
Engineers
•Purchasing
Managers
•Purchasing
Agents
•Supplier
Quality
Engineers
•Quality
Supervisors
•Quality
Inspectors
•Quality
Managers
•Quality Audit
Managers
•Quality
Auditors
Track this Link:
Spreadsheet Validation: Understanding
and Satisfying FDA Requirements
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
