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 124

Computer Validation:

The 10 Worst Mistakes You Can Make

Get 10+ Documents To Do it Right The First Time

Recorded

Despite of more than 30 years experience and availability of FDA and industry guidance, computer validation still confuses people and more mistakes than ever are repeatedly made. Some will cost time and money; others will cause regulatory sanctions and scrutiny

How does the audio seminar help:

Most common mistakes made during software and computer validation will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will not only discuss mistakes repeatedly made in the Pharmaceutical industry but also identify the root causes as well as strategies on how to avoid the mistakes. After the seminar, an extensive list of reference material like SOPs, checklists, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• Mistakes that will result in regulatory actions
• Mistakes that will cost your company valuable time and money
• Obvious reasons for problems with software computer validation
• Strategies to avoid mistakes
• Major issues with recommendations on how to deal with them
  - wrong understanding of regulations&guidelines
  - no planning, insufficient specifications, too much testing of commercial systems
  - testing not documented, no control of unplanned changes,
  - no validation of Excel® spreadsheets

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

• SOPs:
  - Validation of Commercial Off-the-Shelf Computer Systems
  - Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
  - Validation of Web Based Applications
  - Risk Based Validation of Software and Computer Systems
  - Training for GxP, 21 CFR Part 11 and Computer Validation
  - Change Control of Software and Computer systems
  - Validation Of Spreadsheet Applications
  - Auditing Computer Systems
• Gap analysis/checklists:
  - Using computers in FDA regulated environments
  - Software/Computer system vendor qualification
• Templates/examples
  - Complete Validation example - MD5 software: DQ/IQ/OQ/PQ
  - Testing - Traceability Matrix, Test Protocols, Summary report (29 pages)
  - Computer System Identification
  - User Requirement Specifications for Networked Data Systems
• Warning letters and Inspectional observations related to software and computer validation
• FDA/EU Guidance documents related to software and computer validation

Who should attend?

• IT managers and system administrators
• QA managers and personnel
• Analysts and lab managers
• Regulatory affairs
• Validation professionals
• Training departments
• Documentation department
• Consultants

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.