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
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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

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.-

|
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.-

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About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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.
