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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 102

Using Excel® in Part11/GxP Regulated Environments

Recorded

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Spreadsheets like Excel® are frequently used in regulated laboratories and production environment. Some companies have thousands of them. They need to be validated and comply with 21 CFR Part 11 and other regulations. The question is how, because Excel was not designed for part 11 and 'out of the box' Excel does not have all the functions as required by part 11. And spreadsheets applications are readily available, easy to program, and easy to change.

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?
  • Should we test standard Excel functions?
  • Standard Excel does not have part11 compliant audit trail, what to do?
  • Everybody can easily access Excel applications, how to ensure data security and integrity?
  • How to prevent that somebody changes the Excel spreadsheet?

How does the audio seminar help:

Solutions 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. 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 Excel applications - What do inspectors asks and what documents should be available
  • Developing a culture and infrastructure for Macros&Spreadsheet compliance
  • Learn how to design and program Excel spreadsheets with quality and compliance in mind
  • Validation of Macros and Spreadsheet application during development, installation and on-going use
  • How to ensure security and integrity of spreadsheet applications?
  • Which (hidden) Excel functions are available to assist compliance?

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs: Validation of spreadsheets and other computer applications, GxP and part11 training
  • Gap analysis for Macros and Spreadsheet applications
  • Spreadsheet validation project schedule
  • Draft article to be published in Biopharm: Using Macros and Spreadsheets in Regulated Environment
  • FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to Excel
  • And more....

Who should attend

  • QA managers and personnel
  • All developers and users of spreadsheet applications
  • Production and lab managers
  • Regulatory affairs
  • Validation specialists
  • Training department
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

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.