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 220

Risk Based Computer Validation and Part 11 Compliance

With Strategies for FDA/EU Compliance and Practical Tools for Effective implementation

Recorded, Available with all reference material

FDA and other agencies require to "Base software and computer validation and controls of electronic records on a justified and documented risk assessment". This is great because when implemented right it can help to reduce validation and compliance costs. Frequently risk categories are easy to define but the real challenge comes when users should take action to optimize risk mitigation versus costs.

Key Questions are:

• How to define high, medium and low risk systems and electronic records?
• How to develop a risk based validation program?
• Are probability and and severity factors enough or do we also need detectability?
• How to develop and implement a risk based Part 11 compliance program?
• How to validate high, medium and low risk systems?
• Should we make a risk assessment for each software function?
• Should we do anything for low risk systems and records?
• What to test for high/medium and low risk systems and records?
• How to assess the supplier risk?
• How can I justify and document my decision?

How does the this 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 and examples. 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/EU and business requirements
• Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE, PIC/S
• Practical approaches for risk assessments of computers and electronic records
• Developing a risk based software and computer validation program
• Developing a risk based Part 11 compliance program
• Planning and implementing for risk based specifications, vendor assessment, installation, testing, change control, back-up, and contingency planning
• Risk assessment for network infrastructure
• Implementing risk based security, audit trail, back-up, archiving and retrieval of electronic records
• Documenting the decision for management and for the FDA
• Practical examples and specific recommendations from laboratories, office computers and production

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

• Risk Management Master Plan: 40 pages
• SOP: Risk assessment Used for GxP Environments
• SOP: Risk-based Validation of Computer Systems
• SOP: Risk-based Qualification of Network Infrastructure
• SOP: Risk-based Validation of Laboratory Computer Systems
• SOP: 21 CFR Part11 - Scope and Controls (based on risk assessment)
• Reference paper: Risk-based Validation of Off-the-shelf Computer Systems
• Several forms for risk assessment and documentation
• ICH Risk Management guide
• NIST Guide: Risk Management for IT Systems
• Risk Management Guide of the Global Harmonization Task Force (GHFT)
• Warning letters and Inspectional observations related to risk assessment.
• FDA guidance documents and predicate rules
• More .....

Who should attend?

• Everybody who is concerned about cost effective software and computer system validation
• Validation specialists
• IT specialists
• QA managers and personnel
• Software developers
• Users of software and computer systems
• Regulatory affairs
• Training department
• Documentation department
• Consultants

Date, time and duration

Order at any time, replay at any time.

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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

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 chief advisor  for global FDA compliance for Agilent Technologies and other companies.

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.