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 187

Validation and Use of Excel® Spreadsheets in Regulated Environments

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

Recorded

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.

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 validate and use Excel® 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?
• What are the limitations of 'out of the box Excel'?
• What does GAMP suggest for Spreadsheets?
• How to overcome Excel® limitations for Part 11 and other regulations?
• What should we validate?
• Should we test standard Excel® functions?
• Should we validate ad 'hoc' or 'one time use' Excel® spreadsheets?
• 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 their own regulations?
• 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. 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, GxP, HIPAA, Sarbanes-Oxley.
• Typical compliance problems with spreadsheets
• Recommendations from GAMP
• Recommendations from FDA's two Information bulletins for: single users and multiple users of spreadsheet applications.
• How to design spreadsheets for compliance.
• How to ensure and validate spreadsheet integrity.
• When, what and how much to test?
• Validation of standard 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, laboratories and offices

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.

• SOPs:
  - Validation of spreadsheet 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
• 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.