Labcompliance On-line Audio Seminar
This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
On-line Audio Seminar 118
Validation and Use of Excel® Spreadsheets
in GLP/GMP and Part 11 Environments
Excel® Applications are widely used in laboratories, offices and manufacturing
e.g., for data capture, data manipulation and report generation. They are
considered software and should be validated when used in regulated environment.
For example the new FDA Guidance on Using Computers in Clinical Trials states
for spreadsheet applications: FDA suggests that the sponsor or contract research
organization perform functional testing (e.g., by use of test data sets) and
research known software limitations, problems, and defect corrections.
Most Excel® applications are non-trivial, may be widely shared and will contain
significant investments in time and intellectual effort. Frequently users of
such programs are also programmers and are afraid to go through the big efforts
usually associated with software and computer systems validation. Their main job
is not software development or code inspection.
- What is it we should validate?
- I have been using these spreadsheets since years, I know
that they work, why should I start to validate?
- How to overcome Excel® limitations for part 11?
- What to do and document for risk assessment?
- How does FDA's new approach for part 11 compliance impact
- Should we test standard Excel® functions?
- Should we validate ad 'hoc' or 'one time use' Excel®
- What and how much should we document?
- When can we delete e-records and when should we keep them?
- How does the FDA validate spreadsheets for their own
- How to ensure spreadsheet integrity for part 11 compliance?
- How to apply risk based validation to Excel spreadsheets?
How does the audio seminar help:
Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. Dennis
Cantellops from the US FDA will answer questions. After the seminar,
an extensive list of reference material like SOPs, templates and
examples will help immediate and cost effective implementation.
During the interactive presentation you learn about:
- FDA and EU requirements for spreadsheet validation - What do
inspectors ask and what documents should be available.
- How to design spreadsheets for part 11/GxP compliance
- Validation and Part 11 compliance in FDA laboratories: The
FDA information bulletin:
- Validation during design, development, installation and
- When, what and how much to test?
- How to handle standard Excel functions?
- How to ensure and validate spreadsheet integrity for GxP and
- How to apply risk based validation to spreadsheet
- Validation of 'ad hoc' spreadsheet applications.
- How to document planning, specifications, installation,
testing and changes
- Examples from manufacturing, laboratories and offices
And for easy and instant implementation:
download 10+ documents from special seminar website
- FDA Laboratory Information Bulletin I: Spreadsheet Design
and Validation for the Multi-User Application for the Chemistry
Laboratory (not available on FDA's public website).
- FDA Laboratory Information Bulletin II: Spreadsheet Design
and Validation for the Single-User Application for the Chemistry
Laboratory (not available on FDA's public website).
- Validation of spreadsheets and other computer applications,
- Development and use of spreadsheets in regulated environments
- Change control of software and computer systems
- Gap analysis for Macros and Spreadsheet applications
- Spreadsheet validation project schedule
- Requirement specification
- Installation documentation
- Traceability matrix
- Protocols for functional testing
- Summary test sheet
- Article (Published in Biopharm): Using Macros and
Spreadsheets in Regulated Environment
- Software and validation package: File integrity check with
MD5 Hash Calculations
- FDA 483 form inspectional observations, establishment
inspection reports and several warning letters with deviations
related to Excel
- And more....
Who should attend?
- All developers and users of spreadsheet applications
- Validation specialists
- QA managers and personnel
- Production and lab managers
- Regulatory affairs
- Training department
- Documentation department
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
Design, Validation and Use
Excel® Spreadsheets in FDA
Comply with GxPs and Part 11
Dennis Cantellops, US FDA, as Guest Speaker
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- Ask questions through email and web form
About Dr. Ludwig Huber
Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
||Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.
Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,