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 183
Validation and Part 11 Compliance of
Chromatographic Data Systems
- With Validation Examples from Planning to
System Retirement -
Recorded
Chromatographic Data Systems (CDS) are amongst key targets of FDA inspections.
They are considered high risk systems because they can have a high impact on
product quality. Relatively small changes in integration settings can have a
high impact on test results. Therefore such systems should be validated and
operation and use should be thoroughly controlled and integrity of data should
be documented. The questions are how much validation is enough and how to ensure
accuracy, reliability and integrity of results?
Key Questions related to Chromatographic Data Systems (CDS) are
- What and how much to test?
- Are vendor audits required?
- How to define risk categories?
- Should we test standard functions of data systems?
- Haw to validate networked data systems?
- How to validate existing systems?
- What to revalidate and document after changes?
- How to document system security and data integrity?
- How to validate laboratory CDS for Part 11 compliance?
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 examples will help immediate and cost effective
implementation.
During the interactive presentation you learn about:
- FDA and EU requirements for CDS - What do inspectors ask and
what documents should be available.
- Most frequently cited deviations related to CDS.
- How to develop a validation master plan for a CDS?
- How to write a user requirement specification document?
- How to qualify vendors of commercial CDS
- Validation steps: DQ/IQ/OQ/PQ
- Recommendations for risk based validation.
- Validation of existing systems
- Validation of networked data systems
- How to ensure and validate integrity of test results.
- How to plan, implement and document CDS retirement
- Validation of networked data systems and infrastructure.
- How to document planning, specifications, installation,
testing and changes
- Critical steps to comply with FDA's Part11
And for easy and instant implementation:
download 10+ documents from special seminar website
- SOPs:
- Validation of Laboratory Computer Systems
- Risk Assessment for Laboratory Systems
- Risk Based Validation of Laboratory Systems
- Retirement of Computer Systems
- Gap analysis: Laboratory computers systems
- Templates/Examples for Chromatography
- Project plan
- Requirement Specifications
- Vendor qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Test plan
- Test protocols
- Validation report
- FDA 483 inspectional observations and warning letters with
deviations related to laboratory computers
- FDA regulations and guidelines related to computers
- And more....
Who should attend?
- Analysts and lab managers
- QA managers and personnel
- IT administrators
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
- Documentation department
- Consultants
How to order
Pick one of the options in the table that fits your needs.
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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.
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US$ 349.-
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Recorded seminar - CD
- Get the CD in your mail
- Order includes all reference material.
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US$ 349.-
|
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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
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US$ 249.-
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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 author of the Labcompliance Newsletter. He has been
conducting over 100 web and audio or video based seminars since ten years. He is
worldwide director for FDA compliance at Agilent Technologies.
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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 visits FDA in Rockville, VA, and participates
in panel discussions with FDA professionals. For more information,
click here.