Dr. Ludwig Huber -
Chief Advisor - Global ISO 17025 and FDA Compliance
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Contact:
Obere Alm 27
77704 Oberkirch
Germany
Tel.: +49 7802 980582
Fax.: +49 7802 981948
E-mail:
ludwig_huber@labcompliance.com
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Qualification for Compliance
(for a short summary,
click here)
Dr. Ludwig Huber is an expert for FDA and equivalent international
compliance and for ISO/IEC 17025 laboratory accreditation.
While the FDA and other agencies do not provide certification of
compliance for private persons, service providers to regulated industry
should demonstrate expertise and knowledge. Dr. Ludwig Huber has
demonstrated this expertise and knowledge in many areas ranging from simple
literature publications and conference presentations to text books,
2-day workshops, participation in industry task forces and more than 20 years of industry
experience. Below please find the list.
- Good Laboratory Practice and Good Manufacturing Practice, Agilent
Technologies
This book has been translated into 10 different languages. More than
150,000 copies have been distributed.
- Validation of Computerized Analytical Systems (1995), Interpharm
Was the publisher's Best Selling Book in 1996/7
- Validation and Qualification in Analytical Laboratories (1998,
updated in 2007)
- Validation of Computerized Analytical and Networked Systems (2002)
Literature and online Publications
published through www.labcompliance.com
- ISO/IEC 17025
- Good Laboratory Practice Regulations
- Computer System Validation
- 21 CFR Part 11
With audio or video seminars, master plans, SOPs and examples
- ISO/IEC 17025
- Network Qualification
- Computer System Validation
- 21 CFR Part 11
- Macros and Spreadsheets
- Laboratory Compliance
- FDA Inspections
Ranging from 45 minutes to two days
- More than 200 presentations and/or workshops at conferences
- Selected as the IVT Speaker of the Year in 2002 out of 170
presenters
- More than 150 live audio, video and/or web seminars with up to
2000 attendees per session
Industry Compliance Experience
- Responsible for the FDA compliance program at Hewlett-Packard and
Agilent for more than 20 years
- Consulting of pharmaceutical industry and testing laboratories on validation and compliance
for more than 20 years
Laboratory Experience
- Thesis about development of gas chromatographic methods
- Applications chemist for gas chromatographic environmental an
petrochemical analysis
- Managing the Agilent HPLC applications lab for environmental, food
and pharmaceutical analysis
Task Forces
- PDA Part 11 Task force
- IVT Network Qualification
- GAMP America Special Interest Group: Validation of Laboratory
Systems
Member of Advisory Boards (Current and/or past)
- Pharmaceutical Technology Europe
- European Compliance Academy
- IVT Validation Journal
- Board member of 21CFRPart11 Compliance - Newsletter
- Advisory Board for Journal of Accreditation and Quality Assurance in
Laboratories
Awards
- Winner of the Wallhaeusser award, sponsored by the European
Compliance Academy. The award is for publications in the area of 'Quality
and Safety of Drugs'
- Winner of the "First International GLP Award" from Indian Drug
Manufacturer Association for Publications and Presentations in the Area
of GLP and GMP
- IVT's Presenter of the Year, selected from 170 presenters.
Working with the FDA
and PIC/S
- Workshop Leader at FDA Conferences
- Leader of panel discussions with FDA presentations
- Presentation at worldwide PIC/S workshops
- Review of FDA internal documents
Summary of Achievements
(past or present)
- Presenter at conferences/meetings of: PIC/S, PDA,
ISPE, GAMP, US FDA, ECA, HSA (Singapore), SFDA (Shanghai, Peking), KFDA
(Seoul), IDMA
(India), Peking University, USP
- More than 20 years of industry experience with validation
and compliance
- Editor and main author of
www.labcompliance.com
- Chief Advisor for Agilent Technologies
- Chairman, presenter and panel discussion member
at US-FDA Industry Training sessions and conferences
- Member of the advisory board for the European
Compliance Academy (ECA)
- Member of the US PDA task force on 21 CFR Part11
- Member of the GAMP special interest group: lab
equipment
- Member of IVT task force: IT Infrastructure &
Network Qualification
- Presenter of the Year of the Institute for
Validation and Technology
- Member of scientific advisory board of IVT's GxP
Journal
- Board member of Pharmaceutical Technology Europe
- Lifetime International GLP Award from Indian Drug
Manufacturer Association for Publications and Presentations in the Area
of GLP and GMP
- Author of three validation books and more than
100 publications
- 150+ web/audio/video seminars related to
compliance
Testimonials - Feedback on Ludwig Huber's
seminars/workshops/presentations
- Feedback Audio Seminar: Cost Effective Software and Computer System
Validation
The seminar provided valuable information on how to proceed with
validation activities in a manner that does not 'break the bank.' The
information on FDA's and other agencies' current thinking will help
narrow the scope of our validation activities. The templates and other
reference materials will help us consolidate and streamline our current
validation practices. (Ref 1001)
Steve Bonin, MEDTOX Laboratories, Inc.
- Feedback Computer System Validation Package
The package did exceed my expectations. It has more than enough of what
we need to meet regulatory regulations. Very well put together (Ref
1002)
Michael Brooks, AIT Laboratories, Quality Assurance, USA
- Feedback Audio Seminar: Validation and Use of
Excel in Regulated Environments
The seminar did exceed my expectations.
I found this to be extremely useful as to the requirements around this
topic. This gave me a great idea on where to begin the process of
validating spreadsheets. Excellent use of my time.
Brian Howard, MNI, IT, USA
- Feedback Audio Seminar: Residual Solvent Analysis.
The seminar did exceed my expectations.
The speaker explained very clearly how to approach the drastic change
fron OVI to residual solvents. Also clearly explained what FDA
expectations are of NDA and ANDA submissions. Great material and slides.
I like the fact that the speaker talks and doesn't merely read the
slides.(Ref 1003)
Donald Johnson, Pii, Analytical services, USA
- Feedback Audio/Web seminars in general
I have attended many of your seminars, and I enjoy each one. You provide
more detail and finer points than other people who have longer seminars.
I intend to continue taking your webinars in the future. Thank you
again, very much, for your help!
Connie Curts, Notocord Inc, Contractor, Validation Department, USA (Ref 1004)
- Feedback Web Seminar: Analytical Instrument Qualification
The seminar did exceed my expectations. It was a very good presentation,
with a clear message and good material. It worked very well with
webinar.(Ref 1005)
Viveca Frising, AstraZeneca R&D, Analytical Development, Sweden
- Feedback on the ISO 17025 Accreditation Package
The ISO17025 is a comprehensive resource for all your accreditation
needs. Explanations of key points of the accreditation process are well
explained and there is extensive supporting material (SOP's etc) to
allow an organization to successfully speed along the implementation
process. SOP's and Forms are well written and satisfy the principal
components of ISO17025 guidelines. Access to the website provides a
source to access any updates to documentation. (Ref 10017)
Dr. Andrew Wotherspoon, National Research Council, Bioanalytical
Chemistry, Canada
- ISO 17025 Accreditation Package
Feedback: The templates were very useful in starting from the ground
floor. Everything really fits together. Website is very helpful. The
package did exceed my expectations.
Kellie Sorrell, Metrology Solutions Inc., Quality Department, Country,
USA (Ref 1013)
- ISO 17025 Accreditation Package
Feedback: The package did exceed my expectations. The number of
documents especially dealing with the IT side of use in Lab environment
exceed what I was expecting for the purchase. I wish a couple years ago
I knew of this website and access. I do know that I will recommend this
to others.
Peggy Weber; Accelerated Technology Laboratories (ATL); USA,
Project Manager (Ref 1020)
- Feedback Audio Seminar: Effective Training Practices
The seminar did exceed my expectations. The examples were great and the
clear interpretation of the FDA requirements was very helpful. I would
definitely attend another. (Ref 1006)
Nicole St. Croix-Young, GeneNews Corporation Department, Quality
Assurance, Canada
- Audio Seminar: Understanding the New USP <1058> for Analytical
Instrument Qualification.
Feedback:
Although my company has rigorous SOPs for the topic of equipment
qualification it was very beneficial to hear another view on the topic
especially with the USP 1058 in mind. As such Dr Huber gave a very good
presentation and combined with the available documentation enables me to
review our SOPs to update them with 1058 in mind. Seminar was very
enjoyable and pitched at the correct level
Dave Stevenson, Charles
River, United Kingdom (Ref 1007)
- Audio Seminar: Validation and Use of Excel Spreadsheets in Regulated
Environments
Feedback: I used excel throughout graduate school. I needed a guide to
implement excel as a routine tool in my QA Lab. Excellent Seminar. Will
definitely recommend to my peers. (Ref 1008)
Raymond Velez, Cooper Vision, USA, Puerto Rico
- Audio Seminar: Cost Effective Software and Computer System
Validation
Feedback: We are evaluating 2-3 different automated systems this year.
The seminar provided timely information on the current trends of CSV and
brought to light the key differences between GAMP4 and GAMP5. Reviewing
ways to reduce validation testing was a plus.
I definitely enjoyed it and look forward to reading through the
reference material.
The seminar did exceed my expectations. (Ref 1009)
Juan Turner, Pharmachem Technologies, QA, Bahamas
- Two day workshop: Qualification of Instruments and Validation of
Systems in Laboratories
Feedback: The wonderful speaking on workshop and patient answers have
left deep impress upon me. The references must be useful to my
work. Thank you very much once again. Hope to attend your workshop next
time! (Ref 1010)
Xueyun Zhang, Dalian Elite Analytical Instruments Co., Ltd., China
- Audio Seminar: Validation of Existing/Legacy Computer Systems
Feedback: Many presentations regurgitate the same common sense
approaches to validation. This seminar gave a practical step by step
approach, excellent references, and simple templates. This was my first
LC seminar, and it was well worth the cost. I look forward to more. The
seminar did exceed my expectations. (Ref 1011)
Robert Maddock, Forest Research Institute, PRD LOA, USA
- Audio Seminar: Validation of Existing/Legacy Computer Systems
Feedback: I didn't think you'd be able to successfully cover as much
as you did in one hour. There was much I did not know but thought I
knew. The seminar did exceed my expectations. Will definitely sign up
for an other. (Ref 1012)
Ken Woychesko, Tanis Technical Inc., Validation Department, Canada
- Conference Presentation: Method Validation Requirements from the USP
and FDA Impact on Pharmaceutical Analysis
Feedback: The topics presented in the conference were up to the mark and
all speakers were experts from their fields. This conference provided us
an opportunity to personally meet world renowned Speaker Dr. Ludwig
Huber whose literature and notes as published on the website I have been
reading from the start of my career. It was
excellent (Ref 1014)
Amee Kanuga, Veeda Clinical Research, QA, India
- Audio Seminar: Effective Training Practices for FDA
Compliance,
Feedback: We already have a good understanding of training requirements
in the regulated environment. The presentation has provided us with
clear summary, gave proper focus and perspective. It will be very
helpful in revising our existing SOP.
The seminar was informative and well timed with breaks for
interactivity. All subjects were relevant.
Agata Wodzynska .CANTEST Ltd., Human Potential Department, Canada
- Audio Seminar: Planning for Computer Systems
Contingency and Disaster Recovery
Feedback Mr Huber seemed to me very well versed on the subject. I was
greatful for the detail in the presentation. I enjoyed also that he
broke down who or what departments may take responsibility for various
processes of the plan responsibilities. Looking forward to the next
seminar
Brian Howell, Teva Pharmaceuticals, Quality Technical Services
Department, USA
- Audio Seminar: Residual Solvents
According to USP 467
Feedback: The seminar was excellent and exceeded my expectations. An
unambiguous answer was provided about the ''non obligation' to use the
specified USP method for manufacturer of excipient. The remark of
benzene in toluene was excellent. You carefully select areas where the
attendee can read or go deeper by himself at a later time in order to
cover as much as possible. Also you took the time to answer verbally to
the question I have sent 2 weeks ago. You stay on top of new stuff ! Ms.
Michel Boisvert, Anachemia, Canada Inc (Ref 1018)
- Audio Seminar: Master Planning for
Software and Computer Validation
Feedback: The seminar was excellent and exceeded my expectations. I
expected an overview of a Master Plan for computer system validation. I
got that plus more. The included documents and references were very
helpful. The format of the seminar was good. I appreciated having the
transcript of the seminar as a companion document.
This seminar and the Labcompliance web site have been very helpful. I
was overwhelmed, knowing that I needed to generate many documents but
not knowing where or how to start. Now I can get started. Your current
list is so extensive!.
Mr. Andy Young, Celerus Diagnostics. Engineering Department, USA (Ref 1019)
- Audio Seminar:
Effective Gap Analysis
for 17025
Feedback: Excellent materials and expertise from speaker, but too
limited time to present all the material Very valuable for my
professional growth.
Mr. Samuel Barrera, BMS, QC/QA; PR, USA (Ref 2021)
- Audio Seminar: Auditing Computer Systems
Feedback: I needed more QA perspective to complement my IT and
Scientific audit perspectives, and I received more perspectives than I
had imagined..This excellent seminar is provides many insights to avoid
pitfalls and to enhance quality assurance The seminar did exceed my
expectations.
Connie Curts, Notocord Inc, Contractor, Validation Department, USA (Ref 1023)