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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
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On-line Audio Seminar 340

Validation and Control of Excel Spreadsheets for FDA Compliance

Understand requirements and get tool kits for easy implementation

Recorded, available with all reference material at any time

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Testimonials

We have received very positive feedback from attendees of previous seminars and Dr. Huber's is cited in two FDA Spreadsheet Spreadsheet Information Bulletins. To learn how the seminar helped to validate and use Excel in regulated environments, click here.

Introduction

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data evaluation and report generation. Regulations such as FDA's GxPs, 21 CFR Part 11 and the EU-PIC/S Annex 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. FDA specifically cited missing qualification and other Part 11 controls in recent warning letters.

Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on
how to control, validate and use Excel® FDA requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations. The question is how to do this.

Questions related to Excel® are:

  • What exactly is required by the regulations: Part 11, Annex 11, QSR?
  • What are the limitations of 'out of the box Excel'?
  • What does GAMP®5 suggest for Spreadsheets?
  • How to overcome Excel® limitations for Part 11 and other regulations?
  • What should we validate, what should we qualify?
  • Should we test standard Excel® functions?
  • Should we validate 'Ad hoc' or 'one time use' Excel® spreadsheets?
  • FDA cited missing controls of Excel spreadsheets in warning letters: what does this mean?
  • We use Excel templates as calculator, do we need to keep electronic records?
  • What and how much should we document?
  • When can we delete e-records and when should we keep them?
  • How does the FDA comply with their own regulations?
  • How to apply risk based validation to Excel spreadsheets?
  • Is there a validation example from the beginning to the end?

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. 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:

  • Regulatory requirements for spreadsheets: FDA Part 11, and the EU-PIC/S Annex 11
  • Recent inspectional observations and warning letters
  • Recommendations from the new GAMP®5
  • How to design spreadsheets for compliance.
  • How to ensure and validate spreadsheet integrity.
  • How to deal with the audit trail requirement
  • Using a simplified life-cycle for validation
  • When, what and how much to test
  • Validation of standard/native Excel functions
  • 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 and quality control of APIs, drugs and medical devices

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

  • Two FDA Laboratory Information Bulletins (not available from FDA's public website).: -Spreadsheet design and validation for the multi-user and single user applications.
  • PowerPoint Presentation
  • Script
  • SOPs:
    - Validation of spreadsheet applications
    - Development and use of spreadsheets in regulated environments
    - Change Control of Software and Computer Systems
  • Gap analysis/checklist for Macros and Spreadsheet applications
  • Specific User Manual: Useful Excel Functions to Improve Quality and Compliance of Workbooks
  • Excel Application Validation Examples
    - Step-by-Step Validation
    : From Beginning to End
    - Risk Assessment
    - Validation Planning
    - Supplier Assessment
    - Test Plan
    - Design Qualification
    - Requirement
    Specification
    - Installation
    Documentation
    -
    Performance Qualification
    -
    Validation Report
  • 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....

The Speaker Ludwig Huber has been acknowledged  in FDA documents.

 

Ludwig Huber has been asked to review FDA's internal SOP and Lab Information Bulletin on Spreadsheet Validation.

FDA acknowledged Ludwig Huber's contribution in the LIB

Both LIBs are included in the seminar reference material

Who should attend the seminar?

  • All developers and users of spreadsheet applications
  • Validation specialists
  • QA/QC managers, executives, and personnel
  • Production and lab managers
  • IT / IS managers and personnel
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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Testimonials/References

 

 

The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

 

  • Brian Lane, Booz Allen Hamilton/Centers for Disease Control and Prevention (CDC), Laboratory Quality Management Program, USA
    The seminar did exceed my expectations
    I knew little of this subject prior to the webinar, but now I think I possess the knowledge and tools I need. I think it is also significant that Dr. Huber's work is cited in FDA LIB 4317! We GREATLY appreciate all the documents we were able to download (Ref 1073)
  • Dr. Murray Rosenthal, Manager Reagent Technology Department, Alfa Wassermann Diagnostic Technologies, USA
    The seminar did exceed my expectations
    The presentation provided the details needed for us to set up a system to do spreadsheet validation. I thought the speaker had a very effective voice for this type of Webinar format. Ludwig kept our attention throughout the seminar. I believe this is one of the best webinars that I have participated in. This was very valuable to us. We appreciate the opportunity to participate. Thanks! (Ref 1072)
  • Ms.Jenny Lesinski, Advion BioSciences, Inc., IT, USA (Ref 1025)
    The information provided was eye opening. I was unaware that validating was such an easy process or that there was a reliable way to do it. Very Informative. Thank you so much!
  • Raymond Velez, Cooper Vision, USA, Puerto Rico
    I used excel throughout graduate school. I needed a guide to implement excel as a routine tool in my QA Lab. Excellent Seminar. Will definitely recommend to my peers. (Ref 1008)
  • Brian Howard, MNI, IT, USA.
    The seminar did exceed my expectations.
    I found this to be extremely useful as to the requirements around this topic. This gave me a great idea on where to begin the process of validating spreadsheets. Excellent use of my time.
  • Dr. Amanda Stennett, Fresenius Medical Care NA, Research Chemical Engineer, Corporate Research, USA  (Ref T-1049).
    The seminar provided great information specific to the topic and nice Q&A session at the end.
    There were lots of good downloads of examples and procedures available as supporting material, 
  • Ms. Janet Kingsley, WL Gore and Associates, Clinical Reseach, USA (Ref T-1047).
    The seminar did exceed my expectations.  Dr. Huber clearly knew his subject and communicated precisely what is needed to meet regulations. Great seminar.
  • Ms. Aurelia Estela Rascon, CareFusion, Supervisor of Scientific Research Department, USA (Ref T-1043. The seminar did exceed my expectations.  Because it achieved the purpose described. It provided very good references and it was very clearly presented. I liked this seminar because it did not have hidden information, or implied information. The information was very objective and useful. It was noticeable that Dr. Huber was knowledgeable, thank you for having experts presenting.
  • Mr. Damon Talley, SAFC, QA Supervisor, QA, USA (Ref T-1039).
    This was exactly the kind of start off information we were looking for. We are just beginning to consider validation of Excel spreadsheets. Very good information. Really liked the references so we can see where to pursue additional guidance.

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.

 

The Author Dr. Ludwig Huber Working with the FDA

A good relationship with industry and FDA has always been my highest priority. Most issues between industry and FDA can be resolved by having a good understanding of each others position. Personal visits to FDA's centers in Rockville, panel discussions at public conferences, joint industry/FDA workshops and having FDA and industry guest speakers in the Labcompliance audio seminars helped a lot to get a real good understanding on both positions, and to get an insight on what's coming.

The examples below show interactions with the FDA.

 

Ludwig Huber and Paul Lepore, FDA's 'Father of GLP' during a GLP Workshop in Tokyo.

Paul Lepore told the audience how they should prepare for a GLP inspection and what inspectors will ask.

Ludwig Huber explained how to implement computer validation in GLP environment.
1999
   
Nick Buhay, Acting Director in FDA/CDER's Division of Manufacturing and Product Quality, and Ludwig Huber in the Q&A Discussion Session on Laboratory Compliance

2006
Ludwig Huber was on conference program's Part 11 panel discussion with FDA's the Joseph Famulare, Acting Director, Office of Compliance, CDER.

2006
Dennis Cantellops (right) , QA manager at the FDA Labs in Puerto Rico, and author of FDA's Excel Bulletins  spoke at Ludwig Huber's Excel audio seminar as guest speaker.
2005 and in 2009
Ludwig Huber has been asked to review FDA's internal SOP and Lab Information Bulletin on Spreadsheet Validation.

FDA acknowledged Ludwig Huber's contribution in two LIBs
Thomas S. Savage, Senior Coordinator at FDA's Office of Regulatory Affairs,  told the audience that he took quite a lot of material from Ludwig Huber's Labcompliance website. He also said that he regularly visits this website when he wants to learn about news on FDA inspections.
Ludwig Huber in an joint industry/FDA panel discussion at the IVT Part11 conference in Washington DC:  From right to left: Martin Browning, fEduQuest Inc, Paul Motise, US FDA, Kathryn Davidson. Baxter Healthcare, INC, and Ludwig Huber fAgilent, 1999
Ludwig Huber (middle) with FDA's Paul Motise (second from left) and the speaker panel at an IVT conference in Washington (2002). Other speakers, from right to left: Chris Reid, Rebecca Fuller Heyde, and Jeff Beck
2002


Video Clips with FDA Management are on the Lab Compliance Website

FDA management explained FDA's 21st Century Drug cGMP initiative and the impact on Part 11

Mark B. McClellan, MD., PhD; Commissioner of Food and Drugs, Janet Woodcock, MD. ; CDER Director David Horowitz, Director of CDER's Office of Compliance, Joseph Famulare, Director, Div. of Manufacturing & Product Quality Office of Compliance, CDER/FDA
2003

Ludwig Huber (right) and John Murray, FDA, (left), speaking at the IVT Computer System Validation Conference


2004
George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference 2005

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay, Acting Director in FDA/CDERs Division of Manufacturing and Product Quality.

Ludwig Huber (right) with Dr. Robert C. Horan,  FDA, Nicholas Buhay,  and Joseph Famulare, in the joint SINO-SFDA-US FDA cGMP /workshop

  Ludwig Huber has been invited by FDA’s CDER to give a seminar for FDA Quality Professionals

The idea was to share Ludwig’s expertise in the area of laboratory controls, computer validation and integrity of electronic records
  In 2007 Dr. Ludwig Huber has been invited by FDA's Eric Hendrikson to give a post conference tutorial at the annual GMP conference organized by FDA professionals.

Two FDA professionals attended Ludwig's tutorial.  
  Dr. Brenda Uratani, Assistant Country Director US FDA China Offices, and Accociate Prof. Mr. Wang Yamin, Center for Drug Evaluation, SFDA attended Dr. Huber's GMP  compliance workshop at the Bejing University.
Here Dr. Ludwig Huber (left) at lunch with  Dr. Brenda Uratani, , and with Accociate Prof. Mr. Wang Yamin,