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All documents shown here are included in the seminar for instant download

The reference material includes links to FDA and international regulations related to computer systems. 

The handout includes examples for warning letters related to Part 11 and Laboratory Computer systems  

 

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 122

Assessment of Software&Computer System Suppliers

Regulatory requirements and strategies and tools for implementation

Recorded

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When software and computer systems are purchased from vendors, the user is still responsible for the overall validation. The FDA asks for documented evidence of successful validation during development: "Marketing alone does not ensure good software quality", an FDA official said at an FDA/Industry training. Users of computer systems are unsure what to do. Costs for a vendor audit can easily go up to $20,000 and some vendors will even not accept it. On the other hand most of the time there are more efficient alternatives. And information from vendors can be used to reduce validation costs at the user's site, but the the industry needs clear guidance.

Frequent questions related to vendor assessment are:

  • Who is responsible for validation of vendor supplier software: the vendor or the user?
  • Who is responsible for Part11 compliance?
  • What exactly are FDA requirements?
  • When does the FDA require a vendor audit for computer systems?
  • How to develop an efficient supplier assessment program?
  • What to do if vendors don't accept an audit?
  • How to avoid a vendor audit?
  • How to reduce our overall validation costs through vendor audits?
  • Does the FDA accept 3rd party audits?
  • Who is responsible for Part11 compliance?
  • My vendor sold me a 'validated' software. Should I still validate the software at our site?
  • We are a software vendor. What claims can we make about FDA compliance?
  • Should we validate companies like Microsoft, Oracle etc?
  • How should we conduct and document a vendor audit?
  • How frequently should we audit the same vendor?

How does the audio seminar help:

Answers to all these questions 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:

  • Responsibilities of vendors and users for software validation
  • FDA and international requirements for vendor assessment
  • Risk based alternatives for vendor assessment
  • Development of assessment checklists
  • Developing a strategy and an SOPs for vendor assessment
  • 3rd party audits vs. direct vendor audits
  • Part 11 compliance of commercial software: contributions of vendors and users
  • A vendor audit: preparation, conduct, follow up
  • How the vendor audit can help to reduce validation cost
  • Claims the vendor can make about software compliance
  • Documenting vendor assessment

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

  • SOP's:
    - Quality Assessment of Software and Computer System Suppliers
    - Auditing Software Suppliers: Preparation, Conduct, Follow-up
    - Risk Based Validation of Software and Computer Systems
    - Validation of Commercial off-the Shelf Computer Systems
    - Risk Assessment for Systems Used in GxP Environments
    (use this SOP to define how to best qualify the vendor)
  • Worksheets/Gap Analysis/Checklist:
    - Software/Computer System Vendor Qualification
  • Reference papers:
    - Qualification and Validation of Software and Computer Systems
    Part 1: Validation during development
    - Part 2: Qualification of vendors.
    - 21 CFR Part 11 Compliance for Pharmaceutical Laboratories: A Vendor's perspective
    - Support from Instrument Vendors for Compliance
  • Other publications.
  • Regulations and guidance documents related to software validation

Questions and answers will be posted at the seminar website. This includes questions that came through e-mail and during the life seminar.

Who should attend?

  • QA managers and personnel
  • IT managers and personnel
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Consultants
  • Users of computer systems
  • Software development engineers
  • Suppliers of software and computer systems
  • Documentation department

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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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.