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 205
Test Scripts and Protocols for Equipment
and Computer Validation
With SOPs , examples scripts and protocols
for FDA and EMEA compliance
Recorded

Testing is the most time consuming part in the overall software and computer
system validation process. Correct execution and documentation is key for FDA
inspections. Users of equipment hardware and software and IT professionals often
are not sure how to develop test scripts and validation or qualification
protocols.
Key Questions related to test scripts and validation protocols are:
- What do FDA and other regulations say about test scripts and
validation protocols?
- What exactly are the expectations of inspectors?
- How to develop efficient FDA compliant test scripts?
- The FDA expects quantitative testing, what does this mean?
- How much detail do we need?
- When do I need qualification protocols versus test scripts?
- Are test scripts 'official' documents?
- Who writes and approves test scripts for computers: QA, IT
or Operations?
- How to document execution of tests (screen captures,
printouts, video)?
- Who signs and approves test scripts?
- For how long should test scripts and qualification protocols
be archived?
- How to link tests to specifications?
How does the 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. After the
seminar, an extensive list of reference material like SOPs,
templates and test script examples will help immediate and cost
effective implementation.
During the interactive presentation you learn about:
- Requirements for test scripts and qualification protocols in
US and EU
- Test scripts vs. qualification protocols
- Developing an SOP for test scripts
- Developing an SOP for equipment qualification
- Developing templates for test scripts
- Items in generic test script templates
- Items in test templates for specific tests
- Documentation of test execution (screen captures, print outs
etc)
- Handling errors and deviations
- Approval of test scripts and qualification protocols
- Gong through examples: instrumentation, Excel spreadsheet,
network devices
And for easy and instant implementation:
download 10+ documents from special seminar website
- SOP: Development and maintenance of test scripts for
equipment hardware, software and computer systems
- SOP: Qualification of equipment (with test templates)
- SOP: Handling Deviations Obtained During Equipment and
Computer System Testing
- Test protocol for Excel (29 pages with traceability matrix
and examples for functional testing)
- Examples/Forms
- Test plan and test protocol for an electronic document
management system
- Test plan and test protocol for a chromatographic data system
- Testing of a balance
- HPLC Control Software - VWD
- HPLC Control Software – Gradient Pump
- Validation Test Deviation Report
- Authorized System Access
- Testing Electronic audit trail
- Warning letters and Inspectional observations related to
testing.
- Others
Who should attend?
- IT managers and personnel
- QA managers and personnel
- Users of equipment, software, computer systems, networks
- Validation specialists
- Metrology groups
- Regulatory affairs
- 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$ 399.-

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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.
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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.