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 105

Design and Validation of Spreadsheets for Part 11 and GxP Compliance with Dennis Cantellops, US FDA, as Guest Speaker

Recorded

Spreadsheet 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.

Please note: based on many requests we have extended the seminar by 20 minutes to have more time for Q&As with Dennis Cantellops, US FDA, as Guest Speaker

Most spreadsheet 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?
• What to do and document for risk assessment?
• Should we test standard Excel functions?
• Should we validate ad 'hoc' spreadsheets?
• What and how much should we to document?
• How to ensure spreadsheet integrity for part 11 compliance?

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
• How to write a validation plan for simple spreadsheets
• Validation during design, development, installation and on-going use
• When what and how much to test?
• Do we need to verify standard Excel calculations?
• How to ensure and validate spreadsheet integrity?
• Validation of 'ad hoc' spreadsheet applications.
• How to document planning, specifications, installation, testing and changes

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

• FDA Laboratory Information Bulletin: Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory (not available of 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 (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....

With Dennis Cantellops, US FDA, as Guest Speaker

Handout Includes FDA's 40 page Laboratory Information Bulletin about Spreadsheet Design and Validation.

 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
• ConsultantsI

How to order

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

Recorded seminar - Web download 'Site' offer 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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.