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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 click here.

On-line Audio Seminar 118

Validation and Use of Excel® Spreadsheets in GLP/GMP and Part 11 Environments

Recorded

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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.

Questions are:

  • 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 Excel?
  • Should we test standard Excel® functions?
  • Should we validate ad 'hoc' or 'one time use' Excel® spreadsheets?
  • 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 regulations?
  • 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 on-going use
  • When, what and how much to test?
  • How to handle standard Excel functions?
  • How to ensure and validate spreadsheet integrity for GxP and part 11?
  • How to apply risk based validation to spreadsheet applications
  • 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).
  • SOPs:
    - 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
  • Examples
    - 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
  • Consultant

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 Regulated Environments

Comply with GxPs and Part 11

with Dennis Cantellops, US FDA, as Guest Speaker

Click here

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. 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 agencies.

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, click here.