Dr. Ludwig Huber -
Chief Advisor - Global ISO 17025 and FDA Compliance

Contact:
Obere Alm 27
77704 Oberkirch
Germany
Tel.: +49 7802 980582
Fax.: +49 7802 981948
E-mail:
ludwig_huber@labcompliance.com

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.

Author of Text Books

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

More than 100 literature publications
Publisher of the Labcompliance Monthly Newsletter since 10 years

Online Tutorials

published through www.labcompliance.com

ISO/IEC 17025
Good Laboratory Practice Regulations
Computer System Validation
21 CFR Part 11

Compliance Quality Packages

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

Presentations at conferences and seminars

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 US FDA and PIC/S

Workshop Leader at FDA Conferences
Leader of panel discussions with FDA presentations
Validation seminar at FDA CDER Rockville
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, Institute of Drug Control (IDC) Vietnam, Ministry of Health and Welfare (MOHW) Thai land.
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

All the testimonials have been received through the feedback forms to Labcompliance seminars and Compliance packages. The authors agreed to publish them.

Audio seminar: Validation and Use of Excel in Regulated Environments
Feedback: The seminar did exceed my expectations
The presentation provided the details needed for us to set up a system to do spreadsheet validation. I thought the speaker had a very effective voice for this type of Webinar format. Ludwig kept our attention throughout the seminar. I believe this is one of the best webinars that I have participated in. This was very valuable to us. We appreciate the opportunity to participate. Thanks! (Ref 1072)
Dr. Murray Rosenthal, Manager Reagent Technology Department, Alfa Wassermann Diagnostic Technologies, USA
Audio seminar: Validation and Use of Excel in Regulated Environments
The seminar did exceed my expectations
I knew little of this subject prior to the webinar, but now I think I possess the knowledge and tools I need. I think it is also significant that Dr. Huber's work is cited in FDA LIB 4317! We GREATLY appreciate all the documents we were able to download (Ref 1073)
Brian Lane, Booz Allen Hamilton/Centers for Disease Control and Prevention (CDC), Laboratory Quality Management Program, USA
Audio Seminar: Cost Effective Software and Computer System Validation
Feedback: 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.
Computer System Validation Package
Feedback: 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
Computer System Validation Package
The package did exceed my expectations. Very detailed. Good information. All gathered in one place. Examples and SOP documents very valuable. (Ref 1074)
Michael Delancy, Quality Systems Engineer, Mylan Pharmaceuticals, 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
Audio Seminar: Residual Solvent Analysis According to USP 467.
Feedback: 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)
Audio Seminar: Analytical Instrument Qualification according to USP 1058
Feedback: 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
ISO 17025 Accreditation Package
Feedback: The package did exceed my expectations. It gives us a HUGE head start on the lab start up. The cost is minimal compared to the return. EXCELLENT documentation. The package did exceed my expectations. Mr. Russell Hensel, President, Hensel Environmental Biology Laboratories, USA (Ref 1048)
ISO 17025 Accreditation Package
Feedback: 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 1017)
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 for FDA Compliance
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 grateful 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)
Audio Seminar: Validation of Existing/Legacy Computer Systems
Feedback: You present the information in a very clear and concise way. To the point with little fluff. The seminar did exceed my expectations.
Mark Buechler, Paracor Medical, Inc., Operations Department, USA (Ref 1024)
Audio Seminar: Validation and Use of Excel Spreadsheets in Regulated Environments
Feedback: The information provided was eye opening. I was unaware that validating was such an easy process or that there was a reliable way to do it. Very Informative. Thank you so much!
Ms.Jenny Lesinski, Advion BioSciences, Inc., IT, USA (Ref 1025)
Audio Seminar: Management and Validation of Computers for ISO 17025
Feedback: All questions/concerns that I had before attending the seminar were addressed during the presentation. The seminar was very informative.
Ms.Eleanor Britten, Quality Manager, Director's Office, NVSL, USA (T-1026)
Computer System Validation Package
Feedback: The package clearly stated how to do the CSV..
The package did exceed my expectations.
Mr. Suwardi Bambang Irawan Syah, Technical Services, Idaman Pharma Mfg Sdn Bhd,, Malaysia (Ref T-1027)
Computer System Validation Package
Feedback: Comprehensive coverage of topics, excellent examples.
Mr. Jim Dougherty, Sr. Mgr. Software Iron Mountain, IT Software Engineering, Engineering, USA,Ref: T-1028
ISO 17025 Accreditation Package
Feedback: The procedure for each clause specified in the ISO 17025 has been clearly identified and documented through SOPs.
The package did exceed my expectations
Ms.Kathryn Wadle, Technician, Texas Engineering Exp. Station, Energy Systems Lab (ESL), USA (Ref T-1029)
ISO 17025 Accreditation Package
Feedback: The package was a good starting point for our ISO17025 compliance program. It ensured that we did not overlook key requirements, and saved a lot of time in providing a framework to build on. The ISO 17025 Accreditation Package download from Labcompliance gave us a head start in our ISO17025 compliance program and significantly decreased the resources required.
Ms. Brad Whisson, Managing Director, West Minerals Analysis Pty Ltd, Australia
(Ref T-1030)
ISO 17025 Accreditation Package
Feedback: Documents were thorough and self explanatory. Great Resource!! I would definately recommend
The package did exceed my expectations
Ms.Tiffany Weldin, Quality Systems Director, Primex Farms, LLC, Quality Department
USA (Ref T-1031)
Computer System Validation Package
Feedback: Comprehensive coverage with examples. Well structured and broken down into manageable pieces. Aligns and supports the most rigorous examples we have encountered and also demonstrates the inadequacies of less rigorous examples we have seen, helping us to guide our customers. This package is a must have starting point for anyone tasked with insuring a credible software validation effort. Worth many times the price.
The package did exceed my expectations.
Mr. Lawrence DeHeer, President, Blaze Systems Corporation, USA (Ref 1032)
Two day seminar: Equipment Calibration and Qualification in Laboratories
Feedback: I am in charge of QA and QC, your lecture is very helpful for QA and QC to carry out the validation and calibration. Perfect lecture and your good personality gave us a lot of help, thank you for your help. Hope we can meet again.
The seminar did exceed my expectations.
Ms.Sixin Bi, Vice General Manager for Quality Department, CSPC Zhongnuo Pharmaceutical Pharmaceutical Co., Ltd., Shijiazhuang, China (Ref T-1033)
Two day seminar: Equipment Calibration and Qualification in Laboratories
Fedback: The classification of instrument can help user to decide what qualification document needed for the instrument. Very interesting and active to stimulate the students to participate in discussion and through doing exercises to grasp what you presented in class. Well-done, very good and I like the class pattern very much. Every one in class is involved in class content and nobody is bored.
The seminar did exceed my expectations.
Lijun Ji, China CSPC Hebei Huarong Pharmaceutical Co., Ltd., QA& Regulatory Affairs
China (Ref T-1034)
Two day seminar: Practical Computer System Validation and Part 11 Compliance in Laboratories
Feedback: The presentation is very practical. It is a guidance for my work. The presentation cleared many confusions about validation of the HPLCs.And Dr.Huber has answered my questions clearly after returning back from Peking by email. I am preparing the inspection. so It is very useful for me.
The seminar did exceed my expectations.
Mr. Li Jinhong, General Manager Assistant, CSPC NBP Pharmaceutical Co. Ltd., International Regulatory Affairs, China (Ref T-1035)
Two day seminar: Practical Computer System Validation and Part 11 Compliance in Laboratories
Feedback: The seminar provided specific and practical methods to perform computer system validation and equipment qualification. It is helpful to make the laboratories in my company comply with FDA's requirements. It was excellent and helpful
The seminar did exceed my expectations.
Ms. Zhou Yaxin, Quality Manager, CSPC Zhongrun Pharmaceutical , China
(Ref T-1036)
Audio Seminar: FDA Compliant Qualification and Performance Testing of HPLC Systems
Feedback: The presented slides outlined all aspects of the current requirements to the HPLC qualification. The presenter demonstrated great knowledge in the topic during the presentation and Q&A session.
The seminar did exceed my expectations.
Dr. Beatrisa Aronchik, QA Manager Affymax, QC department, USA (Ref T-1037)
Audio Seminar: Stability Testing in Pharmaceutical and API Industry
Feedback: This is what I expected. I needed to have a clear overview in a short time.it was very comprehensive. The seminar did exceed my expectations.
Kevin Breesch, QA Manager Toxicon Europe, QAU, Belgium (Ref T-1054)
Audio Seminar: Learning from Recent FDA Warning Letters Related to Computer Systems and Part 11
Feedback: The seminar did exceed my expectations. Lots of examples given which helped me understand where the focus of the inspectors lies. Excellent seminar. Mark Elsley, Novo Nordisk, Head of Data Management Department , Sweden , Belgium (Ref T-1053)
Audio Seminar: Computer System Validation: Step-by-Step
Feedback: The seminar did exceed my expectations. We are preparing for our first FDA audit as our Clinical Research Department has just finished doing clinical trials for a customer who is now going to market with a new drug. Part of this will require an FDA audit of our LAB. About 60 persons in our lab representing all departments attended and all were impressed on the great amount of information that was conveyed in such a short period. The perfect overview of FDA requirements for our company, Ms. Brian Flaherty, Spectra Laboratories, Sr Technical Writer, IT, USA (Ref T-1052).
Audio Seminar: Computer System Validation: Step-by-Step
Feedback: The seminar did exceed my expectations. The seminar provided a comprehensive discussion of Computer System Validation principles, Thanks Ludwig..I've never been disappointed with one of your seminars. Mr. Larry Gayleard, LG Consulting Services, QA Consultant, USA (Ref T-1051).
Audio Seminar: Effective Training Practices for FDA Compliance
Feedback: The seminar did exceed my expectations. The seminar gives on a platter about the requirement, what happens if you do not follow (warning letters) and a clearly laid procedure how to develop an effective training program. The excellent material did exceed my expectations. Ms. Nilanjana Basu, Lupin Limited, DMG-Technical Training, CQA, India (Ref T-1050).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar provided great information specific to the topic and nice Q&A session at the end. There were lots of good downloads of examples and procedures available as supporting material, Dr. Amanda Stennett, Fresenius Medical Care NA, Research Chemical Engineer, Corporate Research, USA (Ref T-1049).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar did exceed my expectations. Dr. Huber clearly knew his subject and communicated precisely what is needed to meet regualations. Great seminar. Ms. Janet Kingsley, WL Gore and Associates, Clinical Reseach, USA (Ref T-1047).
Audio Seminar: FDA's New Enforcement of 21 CFR Part 11
Feedback: The seminar did exceed my expectations. The presentation was clear concise and to the point. The program presented a common sense and accurate approach to Part 11 compliance. A good level of detail and examples was presented. Information will be used soon. Thank You. Mr. Michael Piacenza, Linde, Medical & FDA Compliance Mgr, USA (Ref T-1046).
Audio Seminar: FDA's New Enforcement of 21 CFR Part 11
Feedback: The seminar did exceed my expectations. OUTSTANDING CONTENT. Each slide has important and significant details. M. Huber's comments added and excellent examples, had excellent explanations to ensure the information was clearly understood, and had extra information to enhance and deepen the understand. Much value added to the slides. The usage of colors Red vs. Black on slides 29 and 30 is VERY helpful. Colors give me confidence I can review slides one year from now and correctly understand what the slide is comparing and which items belong to which category of information compared. Inclusion of EU information increasingly important to me, because most of my clientele are now in European and Asian countries. All my EU questions were answered. The seminar showed me at least 2 more ways to further enhance Part 11 compliance.
Although GMP was the focus, GLP was included, and put into good perspective.
Connie Curts, Regulatory Affairs and Validation Consultant, Associated with Notocord, USA (Ref T-1045).
Audio Seminar: FDA's New Enforcement of 21 CFR Part 11
Feedback: The seminar did exceed my expectations. Good and clear presentation, links, references, examples. Excellent, I will recommend my co-workers to participate
Dr. Vladimir Veselov, Cordis - Johnson and Johnson, Principal Scientist, USA (Ref T-1044).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar did exceed my expectations. Because it achieved the purpose described. It provided very good references and it was very clearly presented. I liked this seminar because it did not have hidden information, or implied information. The information was very objective and useful.
It was noticeable that Dr. Huber was knowledgeable, thank you for having experts presenting. Ms. Aurelia Estela Rascon, CareFusion, Supervisor of Scientific Research Department, USA (Ref T-1043.
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar did exceed my expectations. Dr. Ludwig Huber gave very practical, real world advice and suggestions. Having access to download the S.O.P.'s and documents on the spot was a huge plus. I really enjoyed the sharing of materials. This is something that can help right now.
Ms. Andrea Hands, WL Gore & Associates,Inc, , Testing and Validation Analyst, USA (Ref T-1042).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar did exceed my expectations. Dr. Ludwig Huber gave very practical, real world advice and suggestions. Having access to download the S.O.P.'s and documents on the spot was a huge plus. I really enjoyed the sharing of materials. This is something that can help right now. I have no further recommendations as I felt this was one of the best web seminars I have attended
Ms. Andrea Hands, WL Gore & Associates, Inc, , Testing and Validation Analyst, USA (Ref T-1041).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar did exceed my expectations. Excellent knowledge and a lot covered in the hour. Very good seminar.
Dr. Ron Kneisler, Albermarle Corporation, QA Advisor, Quality Department, USA (Ref T-1040).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: This was exactly the kind of start off information we were looking for. We are just beginning to consider validation of Excel spreadsheets. Very good information. Really liked the references so we can see where to pursue additional guidance.
Mr. Damon Talley, SAFC, QA Supervisor, QA, USA (Ref T-1039).
Audio Seminar: Validation and Use of Excel® Spreadsheets in Regulated Environments
Feedback: The seminar did exceed my expectations. Dr. Huber did not just provide high level information but practical real world advice on methods to use to meet spirit of regulations
Ms. Dionne Boyce, WL Gore & Associates, Inc, , Validation Analyst, USA (Ref T-1038).
Macro and Spreadsheet Quality Package
Feedback: The package did exceed my expectations..The set of documentation covers the entire scope of Excel spreadsheet utilization in a regulated environment (either in the binder or the CDROM). Well done ! Totally professional !!. (Ref 1060)
Mr. Michael Capel, IT Director of Stryker, France.
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Dr. Ludwig Huber - Chief Advisor - Global ISO 17025 and FDA Compliance