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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
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On-line Audio Seminar 278

How to get the most out of Supplier Support  for Equipment and Computer Validation

Strategies for suppliers to maximize business and for users to minimize validation cost

Recorded, available with all reference material at any time

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FDA's and industry task forces recommend leveraging vendor support for equipment qualification and computer system validation. For example GAMP 5 states: "Although the responsibility for compliance with GxP regulations lies with the regulated company, the supplier may have considerable involvement in the process. Regulated companies wish to leverage supplier knowledge and documentation".  Regulated companies are unsure what and how much validation support they can expect and ask for, suppliers on the other hand are unsure what the exact expectations of the regulated users are.

Frequent questions related to supplier validation support are:

  • Who is responsible for validation of software: the supplier or the user?
  • What can regulated companies expect from suppliers?
  • We are a software vendor. What claims can we make about FDA compliance?
  • What documentation should suppliers offer?
  • How can vendors help with design qualification?
  • How to develop an efficient supplier assessment program?
  • What type of documented evidence should users have to leverage supplier testing?
  • My vendor sold me a 'validated' software. Should I still validate the software at our site?
  • How much can overall validation cost be reduced through supplier support?

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 equipment qualification and software validation
  • FDA and international requirements for supplier/user agreements
  • Criteria for selecting the right supplier for regulated environments
  • Claims vendors can make about software compliance
  • What suppliers should offer to regulated users
  • What regulated users should expect from suppliers
  • Help during design qualification of equipment and computers
  • Assistance for supplier assessment
  • Contribution during installation
  • Help for operational qualification and requalification
  • Leveraging suppliers hardware and software testing for users tests
  • 10 reasons why operational qualification is performed by suppliers
  • The importance of vendor services for (preventive)  maintenance
  • Documents that should be provided by the supplier

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

  • SOP's:
    - Quality Assessment of Software and Computer System Suppliers
    - Selecting the right software and equipment supplier for compliance
    -  Developing an effective supplier program to assists regulated users
    - Auditing a Supplier’s Equipment Master Validation Plan
  • Checklist:
    - What regulated users should expect from suppliers
    - What suppliers should offer to regulated users
    - Auditing a Supplier’s Equipment Master Validation Plan
  • Template and examples
    -  Supplier quality agreement
    -  Assessment of an Electronic Document Management System Supplier
    -  Assessment of HPLC System Supplier
  • 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 Software and Instrument Suppliers for Compliance

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?

  • Marketing professionals of equipment and computer system suppliers
  • QA managers and personnel
  • IT managers and personnel
  • Validation specialists
  • Regulatory affairs
  • Consultants
  • Purchasers of equipment and computer systems
  • Software development engineers
  • Documentation department

Date and time

Recorded seminar, available at any time with all reference material

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.