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Ten 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber. 

 

 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

FDA Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

Recorded

 

Implementing the New Final EU-GMP Annex 15 on Validation and Qualification
New requirements and strategies for implementation
Recorded 

 

Managing Electronic Raw Data in Regulated Environments
Definition, generation, evaluation and archiving for FDA, PIC/S and EU compliance
Recorded

 

New Official Guidelines and Trends in Analytical Method Validation and Transfer
Don't miss the key points and get strategies for selective implementation
Recorded

 

Below find validation books and compliance packages, all authored by Ludwig Huber

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

Contact:
E-mail:
ludwig_huber@labcompliance.com

Ludwig Huber offers new in-Person Workshops

Labcompliance has extended the offerings for in-Person workshops in several areas: "Computer System Validation and Part 11/Annex 11  Compliance", "GMP Compliance for Quality Control and Contract Laboratories",. "Analytical Method Validation, Verification and Transfer", "Analytical Instrument Qualification and System Validation" and "Validation and Part 11 Compliance in Laboratories". All workshops can be delivered as public and as in-house workshops. Public workshops typically are organized and managed by professional conference providers. In-house seminars are organized either by professional conference providers or by the end-user company. For a complete list of workshops with ordering process and links to pages with individual contents, click here.

Testimonials for Ludwig Huber's Seminars and Compliance Packages

Click here

Qualification for Compliance (for a short summary, click here)
Qualification for Compliance (for a detailed list, click here)

 

Dr. Ludwig Huber is a leading 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, multiple-day workshops, participation in industry and regulatory task task forces and more than 25 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
    This was the first book describing the 4Q lifecycle model for laboratory equipment qualification and computer validation
  • Validation and Qualification in Analytical Laboratories (1998, updated in 2007)
  • Validation of Computerized Analytical and Networked Systems (2002)

Literature and online Publications

Online Tutorials

published through www.labcompliance.com

  • ISO/IEC 17025
  • Good Laboratory Practice Regulations
  • Analytical instrument qualification
  • Computer System Validation
  • 21 CFR Part 11
  • Risk Assessment

Compliance Quality Packages

With audio 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 and wokshops

Ranging from 45 minutes to several 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 250 live audio, video and/or web seminars with  up to 2000 attendees per session
    Presented for Labcompliance, IVT, ComplianceOnline, GlobalCompliancePannel, FXConferences, Agilent Technologies
  • This includes events and trainings with and for the US FDA, PIC/S, ISPE, GAMP, ECA, PDA, IVT, several national health care agency such as China SFDA/FDA, Korean FDA (now MFDS), Singapore HSA, Philippine FDA,  IDMA (India), Peking University, USP, Institute of Drug Control (IDC) Vietnam, Ministry of Health and Welfare (MOHW), Thai land and many pharmaceutical organizations.

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

Industry Compliance Experience

  • Responsible for the FDA compliance program at Hewlett-Packard and Agilent for more than 20 years
  • Consulting and training 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
  • German federal/states GLP committee to interpret OECD consensus documents

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

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, Compliance packages. and SOPs The authors agreed to publish them. All information on the submitters of the testimonials can be reviewed in the Labcompliance archive.

  1. Labcompliance Documentation, e.g., SOPs
    Feedback: Mr. Huber and Labcompliance has been catalytic in our process reorganizing and reconstruction of SOPs. A great source of knowledge and lifelong experience that helped us meet the standards in a professional and credible manner. Mr. Fotis Stathopoulos, Managing Director of Infoset, Greece, Infoset is a specialized consulting firm focusing on the pharmaceutical industry. Infoset aims to fundamentally transform the way clinical data is collected, analyzed and managed. (Ref 3001)
  2. ISO 17025 Accreditation Package
    Feedback: The package did exceed my expectations. The ISO 17025 Labcompliance Accreditation package is very insightful, practical, easy to understand, and there are a ton of additional resources offered to download when you have purchased this package for your laboratory accreditation and implementation of ISO 17025. Our Laboratory Manager, myself (quality manager, safety chair, director of special projects), and our Vice President of Operations are all very glad that I chose to buy the Labcompliance package. Just after two implementation meetings, the vice president of operations said "wow, this is actually good", and referring to certain sections of the laboratory quality manual: "this is good stuff!".
    The manual uses a consistent structure and terminology which applies throughout the manual and SOP's which makes it very easy to understand and incorporate into your companies existing quality management system, or to implement for the first time a great laboratory quality management system. I highly recommend the complete ISO 17025 Laboratory Accreditation Package to any company with a testing / calibration laboratory. Trust me, I have done my research and due diligence. This is the best one out there; don't waste your time looking for others that could lead you down a wrong path. When you get this package and start reviewing it, you will say to yourself "this is a LOT of work"; but then you will say, "Boy am I glad I bought this!"
    Mr. Andrew Glum, Director of Special Products and Quality Manager, Madge Tech, Inc., USA, l, (Ref 1085)
  3. Computer System Validation Package
    Background: Mr. Luistro has bought the CSV package in preparation for an FDA inspection. Here is the feedback after he had received the package:

    The package did exceed my expectations. The CSV package is very comprehensive and complete. The CSV package is a must for every IT Department gearing towards FDA Aligned documents. It is simple but very effective.
     
    And he had additional Feedback after the FDA Inspection:
    Hello Sir Ludwig,, We have passed the FDA Audit just concluded yesterday.
    Thanks for your SOP and Templates. It help me a lot understand and explain to the auditor our own CSV Procedures. All documents are very helpful.
    Thanks a lot!, Regards,
    ANTHONY JONATHAN LUISTRO MCT, MCITP, CCNP, Linux+ MIS Manager
    MIS Section, Administration Department, Terumo (Phils) Corporation
    (Ref 1142)
  4. Computer System Validation Package
    The package did exceed my expectations. It package has helped me create a CSV system for a company. CSV is an overwhelming concept to begin with, so the primer with step-by-step implementation was great to help determine a starting point. Many packages offer direction without specific SOPs, this package goes above and beyond by offering example SOPs, templates, and plans and the primer to help implement the system. I would *highly* recommend this package to anyone who needs to start a CSV system or even review their current CSV system. The checklists are very valuable tools for making sure that your CSV system will hold up to any audit. Ms Alecia Oswald, Manager Information Systems, LVT inc, USA (Ref 1048)
  5. ISO 17025 Accreditation Package with Ludwig Huber
    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. Mr. Russell Hensel, President, Hensel Environmental Biology Laboratories, USA (Ref 1048)
  6. ISO 17025 Accreditation Package, with Ludwig Huber
    Feedback: The package did exceed my expectations. The ISO Accreditation Package, was very helpful on the start-up of our laboratory especially on our documentation system. It is a complete package. The necessary requirements for ISO accreditation are there. Ms Rona Canilao, Trans World Trading Co, Chief Chemist, Chemical Department, Philippines (Ref 1086)
  7. Audio seminar: Ludwig Huber, 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
  8. Audio seminar Ludwig Huber: 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
  9. Audio Seminar with Ludwig Huber: Cost Effective Software and Computer System Validation 
    Ludwig Huber

    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.
  10. Computer System Validation Package, with Ludwig Huber
    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
  11. Computer System Validation Package, with Ludwig Huber
    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
  12. Feedback Audio Seminar with Ludwig Huber: 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
  13. Audio Seminar Ludwig Huber: 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 fro
    m 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
  14. Feedback Audio/Web seminars in general with Ludwig Huber
    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)
  15. 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
  16. ISO 17025 Accreditation Package, with Ludwig Huber
    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
  17. 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)
  18. ISO 17025 Accreditation Package, with Ludwig Huber
    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)
  19. 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
  20. Audio Seminar with Ludwig Huber: 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)
  21. 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
  22. 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
  23. Two day workshop with Ludwig Huber: 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
  24. 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 
  25. 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 
  26. 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  
  27. 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 
  28. Audio Seminar with Ludwig Huber: 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
  29. 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)
  30. 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)
  31. Audio Seminar with Ludwig Huber: 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)
  32. Audio Seminar with Ludwig Huber: 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)
  33. Audio Seminar with Ludwig Huber:
    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)
  34. Audio Seminar with Ludwig Huber:
    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)
  35. Audio Seminar with Ludwig Huber:
    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)
  36. Computer System Validation Package with Ludwig Huber
    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)
  37. Computer System Validation Package,Ludwig Huber
    Feedback: Comprehensive coverage of topics, excellent examples.
    Mr. Jim Dougherty, Sr. Mgr. Software Iron Mountain, IT Software Engineering,  Engineering, USA,Ref: T-1028
  38. ISO 17025 Accreditation Package. Ludwig Huber
    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)
  39. ISO 17025 Accreditation Package, Ludwig Huber
    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)
  40. ISO 17025 Accreditation Package, Ludwig Huber
    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)
  41. Computer System Validation Package,Ludwig Huber
    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)
  42. Two day seminar: Equipment Calibration and Qualification in Laboratories
    with Ludwig Huber
    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)
  43. Two day seminar: Equipment Calibration and Qualification in Laboratories
    with Ludwig Huber

    Feedback: 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)
  44. Two day seminar: Practical Computer System Validation and Part 11 Compliance in Laboratories; with Ludwig Huber
    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)
  45. Two day seminar: Practical Computer System Validation and Part 11 Compliance in Laboratories, with Ludwig Huber
    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)
  46. Audio Seminar with Ludwig Huber:
    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)
  47. 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)
  48. Audio Seminar with Ludwig Huber: 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)
  49. Audio Seminar with Ludwig Huber: 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).
  50. 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)
  51. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback:
    The seminar was excellent. The seminar did exceed my expectations. Information is as per current regulatory guidance and included data integrity and Part 11 very well. . Dr.. Bhavil Kumar Norola, Sun Pharma, Senior Manager Technical Training Academy, India (Ref T-2137).
  52. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback:
    The seminar was excellent. Current regulatory requirements have been expliained in a way that they ere easy to understand. . .Ms. Neeta Sant, Sai Life Sciences, Asst.General Manager, QA, India, India (Ref T-2136).
  53. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback:
    The seminar was very informative. It contained many real life scenarios and challenges that I used to face . . Mr. Shashank Pandey, Zydus Cadilla, IT Validation and Compliance, Corporate Quality Control, India (Ref T-2135).
  54. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback:
    The seminar was a great learning for me in 2 days and it has cleared many questions I had about overall validation and about about 21CFRPART11 and data integrity.  The step by step approach helped to understand the validation process. Mr. Santosh Pawaskar, Emerson, Manager, PSS Department, India (Ref T-2134).
  55. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback: The seminar did exceed my expectation. All areas were covered although briefly but nicely. The presentation was excellent and also the presenter's good interaction with all participants. Mr.
    Koushik Rajaram, Aris Pharma, Head Quality, Quality Department, India (Ref T-2133).
  56. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback:
    I got good knowledge about working profile of mine and future prospects. and also got clarifications of general mistakes which should be avoided in future.  Mr. Umesh Rajani, Sun Pharma, Computer System Validation, IT-CSV department, India (Ref T-2132).
  57. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    : The seminar was excellent and it did exceed my expectations, It was very useful and I got all my quires clarified, Mr.Himanshu Shekhar, Pathak,  Astrazeneca Pharma, Validation Lead, Technical services Department India (Ref T-2131).
  58. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    : The seminar did exceed my expectations, It was a great one to start with definitive examples. It was was worth the time spent and the knowledge gained. The seminar had practical examples on how to manage a computer system in a regulated environment with definitive answers to critical systems management. Mr.Sridhar Kulkarni, Dr. Reddy's Laboratories, Manager, QA Department, India (Ref T-2130).
  59. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    : The seminar did exceed my expectations. It was helpful as I got to know what are regulatory requirement for Validation. Dr. Ludwig Huber was extremely knowledgeable and supportive. He replied to all questions even during breaks and after the seminar.  .Mr. Ulhas Nadekar, Sciformix Technologies Pvt.Ltd, Quality manager, Pharmacovigilance department, India (Ref T-2129)
  60. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    : Seminar was very informative and it did meet the expectations. The seminar came with good, informative study material .
    All queries were sorted out. T
    hank you Dr. Ludwig Huber
    .  .Mr. Ashwini Kulkarni, Emcure Pharmaceuticals Ltd, Senior Executive, Quality Assurance Department, India (Ref T-2128)
  61. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    : Seminar was very informative and it did exceed my expectations. It was  was extremely helpful and it gave me the knowledge about what Regulatory Authorities expectations are. Dr. Ludwig Huber was extremely knowledgeable and responded to all queries which I had  .Mr. Midhun RaJ K Nadekar, Sciformix Technologies Pvt.Ltd, Senior quality specialist, Pharmacovigilance department,, India (Ref T-2127)
  62. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback: The seminar did exceed my expectations.
    The seminar gave me insight right from the basic concepts to the advance level which will help in correcting / directing initiatives to achieve compliance . Dr.Huber is definitly a Super Subject matter expert and he communicates the topics very effectively . Mr. Shibin Chulliparambil, Cipla Limited, Head IT, India (Ref T-2126).

  63. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    : The seminar did exceed my expectations.  I got better clarity and understanding of validation and part 11 compliance of computer system and data  .Mr, Avadhut Patil, Polypeptide, Executive Quality Control, India (Ref T-2125)
  64. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    :  The seminar was thoroughly informative and it was explained beautifully such that despite being from a non-IT background, I could understand the topic well enough. The seminar covered important topics and I especially liked the way in which the compliance topics were explained using examples of FDA warning letters .The seminar was very well conducted and was on-time. There were no unnecessary delays. Ms. Divya Krishnakumar, ACG Associated Capsules Pvt. Ltd, Sr. Executive, Central Quality Assurance Department,. India (Ref T-2124)
  65. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    :  The seminar was very helpful. It helped me to be updated with the regulatory requirements for the industry. I was especially interested in the data integrity topic. Topics covered on e-signatures and audit trails was most of interest.. Ms. Neva Sahant,  ACG Associated Capsules Pvt. Ltd, Sr. Executive, Regulatory Affairs Department, india (Ref T-2123)
  66. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    :  The seminar did exceed my expectations. It was very informative and  discussion with Dr. Huber were very much interactive. , Mr Sanjiv Sharma, Panacea Biotec, AGM, QA Department, india (Ref T-2122)
  67. 2-Day seminar: Validation and Part 11 Compliance of Computer Systems and Data
    Feedback
    :  The seminar was excellent and it did exceed my expectations. It  included nice and excellent presentations on Computer System Validation. It did clarify all queries related to CSV and also provided important tips for another points like Network qualification, Cloud qualification etc. Mr. Rahul Jain, Lambda Therapeutic, Assistant General Manage,  BioAnalytical department, India (Ref T-2121)
  68. 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).
  69. 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).
  70. 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).
  71. Audio Seminar with Ludwig Huber: 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).
  72. Audio Seminar with Ludwig Huber:  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).
  73. Audio Seminar  with Ludwig Huber: 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).
  74. 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.
  75. 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).
  76. 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).
  77. 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).
  78. 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).
  79. 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).
  80. 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.
  81. Audio Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
    Feedback:
    The seminar did exceed my expectations.  Dr. Huber knows exactly what the FDA is expecting. Very concrete recommendations and good examples. Very good seminar and well organized.
    Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany
    (Ref T-1076).
  82. Audio Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar did meet my expectations.  I always expect a wonderful seminar from Dr. Huber, and my expectations were once again met. A great time saver for me as I do not have time to look up recent 483s relating to Part 11 -- worth the time and cost.
    Ms. Diana Mayes, Manager of ABC Laboratories, USA
    (Ref T-1077).
  83. Audio Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar did exceed my expectations.  Webinar was very informative to our current practice and will help us focus and stream line our process. I would recommend this seminar to everyone having the same responsibilities.
    Mr. Mike Robertson, QA Engineer at Energizer, USA
    (Ref T-1078).
  84. Computer System Validation Package, with Ludwig Huber
    Feedback: Material provided was able to reinforce my knowledge of computer system validation and add practical examples. Material provided was a great introduction and hands on tool for me
    Mr. Steve Krueger, Owner, MAK and Associates,, USA
    (Ref T-107
    9).
  85. Laboratory Compliance Package,Ludwig Huber
    Feedback: span>
    The package helped us pursue our target. The documents were  jumpstart procedures for us to implement. More and more corporates must start utilising Mr.Hubers resources as a training methods for clear understanding of his concepts
    Mr. VenkideshRamadoss, VP Quality Control, Caplin Point Labs.Ltd., Chennai,  
    India (Ref T-1080).).
  86. Audio Seminar with Ludwig Huber:
    Understanding and Preparing for FDA's New Part 11 Inspection Programstrong>
    Feedback: The seminar did exceed my expectations.  Very informative presentation, and clearly presented . Dr Huber does an excellent presentation, well developed, and very informative, as usual.
    Mr. John Egoville, Teva Pharmaceuticals, Senior Compliance Auditor, Computer Validation Group Country  USA
    (Ref T-10
    81).
  87. Audio Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  The presentation contains much more pertinent information than I had expected. As mentioned above, the seminar is very useful as it contains a lot of information.
    Mr. Lucian Hirtiee, Labstat International ULC QS Manager, Canada
    (Ref T-10
    82).
  88. Audio Seminar:  Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11
    Feedback: I basically wanted a overview of what the FDA is looking for and this webinar fit my needs exactly. I thought the presentation of the material was done very well, DR Huber is obviously knowledgeable and he presented the subject matter very clearly.
    Mr. Gene Rideout, Instrumentation laboratory, Software Quality assurance, R&D,   USA
    (Ref T-108
    3).
  89. Audio Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  Dr. Huber did a very good job going in detail of this topic. Great Seminar.
    M
    s. Kimberly Stark, Nspirehealth, Director QA/RA, USA (Ref T-1084).
  90. Audio Seminar with Ludwig Huber: How to Efficiently Build a GLP Laboratory
    Feedback: The seminar was very well done, provided a lot of useful information, and made me think about a lot of things I hadn't already thought of. My todo list definitely grew as a result of the seminar (which is a good thing). Overall, the seminar was very helpful to me, and actually I have referred back to it on two different occasions, and I reviewed the slides even more. Thank you
    Ms. Sandra Boehm, Wisconsin National Primate Research Center, Compliance Coordinator, QA Department
    (Ref T-1087).
  91. Full Day Web Seminar: Design and Validation of Excel Spreadsheets: Step-by-Step
    Feedback: The seminar did exceed my expectations. The instructor was clear with his presentation and gave detailed information. I found this webinar very useful and interesting.
    Ms. Lisa Quinones, Kyowa Hakko Kirin Pharma, Inc., Sr.Admin Assistant, QA Department, USA
    (Ref T-1088).
  92. Audio Seminar: Latest Compliance Updates for Computer Systems
    Feedback: We used the information in the audio Seminar and the attached documents to create 7 Computer Validation SOPS. The audio Seminar provided good value for our money. Thank You, we will order again in the future.
    Mr. Carlos Pereira, Cangene Corporation Computer Validation Coordinator, Canada (Ref T-1089).
  93. Audio Seminar: Understanding FDA's 21 CFR Part 11
    Feedback: The seminar did exceed my expectations. It very clearly explained what to think about and how to go about meeting your company's compliance to this guidance. Ludwig Huber is clearly very qualified to led this discussion. I received the information I was hoping to get from this seminar. I really appreciated all of the reference material available until Feb 28,
    Ms. Laura Roberts, Sunrise Medical , Sr Manager Regulatory Affairs  USA (Ref T-1090).
  94. Audio Seminar: Understanding and Implementing the New EU Annex 11
    Feedback: The seminar did exceed my expectations. Very clear description of the requirements.  Good examples from practice.  Good references. Very good seminar. Recommendation to visit.
    Mr. Joachim Fehr, Stryker Leibinger GmbH&Co, CSV Specialist / DPO CSV, QA / CSV Department,  Germany (Ref T-1091).
  95. Audio Seminar: Understanding FDA's 21 CFR Part 11
    Feedback: The seminar did exceed my expectations. I found the reference material to be extremely helpful.  I feel this seminar was accurate, concise, and very well organized..
    Ms. Jennifer Eagan, Cyanta Analytical Services, Associate Director of QA Department, USA (Ref T-1092).
  96. Two day seminar: Validation and Part 11 Compliance of Computer Systems
    Feedback:
    The seminar did exceed my expectations. Fundamentals of computer validation nicely explained.  Also how to use common sense in Validation became more clearer. Dr. Ludwig has a good control on the subject.
    Mr. Kalpeshkumar Vaghela, CEO, Infra Control Systems, India (Ref T-
    2110)
  97. Two day seminar: Validation and Part 11 Compliance of Computer Systems
    Feedback:
    The seminar did exceed my expectations. Contents of the seminar were very good and based on these we have listed out 35 procedures to be prepared to cope up with 21CFR guidelines. And our existing SOP & master plan needs to be revised to include more points. It was excellent and myself learned lot of new things related to my filed. Thanks to Dr. Huber and Global compliance Panel.
    Mr. Tejpal Amonkar, Sr. Executive, IT Department,  Ratiopharm India Pvt. Lt., A Teva Group, Company, Verna-Goa,
    India (Ref T-2109)
  98. Two day seminar: Validation and Part 11 Compliance of Computer Systems
    Feedback:
    The seminar did exceed my expectations. Very useful tool, to implement the concept as per current regulatory norms .
    Mr.
    R. Shaik Mohamed Noor, Sr. Manager, Quality Control,  Shasun,  India (Ref T-2108.
  99. Two day seminar: Validation and Part 11 Compliance of Computer Systems
    Feedback:
     Great value addition to the information on the IT compliance in GxP environment .  Excellent coaching on IT compliance.
    M
    r.
    Nandan Thakur, CSV. Manager, IT Compliance,  TCS,  India (Ref T-2107).
  100. Audio Seminar: IT Infrastructure and Network Qualification: Step-by-Step
    Feedback:
    I'm new to the GxP IT world. The seminar was useful. I quickly gained an overview of network qualification. I would recommend the seminar to other IT professsionals.
    Mr. Carmelo Rodriges, Amicus Therapeutics, Director Information TechnologyDepartment, USA, USA (Ref T-1
    105).
  101. Audio Seminar: Transfer of Analytical Procedures According to the New USP Chapter <1224> 
    Feedback: The seminar did exceed my expectations. We were looking for some information to evaluate transfer requirements when an analytical method is transferred between our QC - Analytical Development and QC - Operations groups. This seminar gave a wealth of information about the subject and provided many options and examples that will help in our evaluation. The subject matter was provided in an easy to follow format and was well presented. Overall, the speaker was very knowledgeable of the subject and a lot of good information was conveyed.
    Mr. Ben Crosby Rodriges, Kremers Urban Pharmaceuticals, Supervisor Analytical Development, USA, (Ref T-
    1146).
  102. Audio Seminar: Infrastructure and Network Qualification: Step-by-Step
    Feedback:
    The seminar did exceed my expectations. It was a very good seminar and I learn more from it than from the published guides on the topic
    Mr. Francois Njieha, , Kwelong, Inc., CSV Engineer, USA (Ref T-1111)..
  103. Audio Seminar: IT Infrastructure and Network Qualification: Step-by-Step
    Feedback:
    The seminar did exceed my expectations. All parts of networks and infrastructure that I remember were clearly addressed. Thank you and congratulations!
    Mr. Paulo Marques, Bial,  IT/IS Quality Assurance, Portugal  
    (T-1112).
  104. Audio Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments
    Feedback:
    The seminar did exceed my expectations. Content was solid and associated materials are very helpful. The presentation covered a broad range of relev
    ent topics. Dr. Huber certainly knows his subject.
    Dr. Teri Stokes, GXP International, Director, USA (Ref T-1168).
  105. Audio Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments
    Feedback:
    The seminar did meet my expectations. Excellent overview and touched on the many esoteric issues that need to be considered. Generally well done (excellent organization, pacing).
    Mr. Mr. Don Hurd, The Realtime Group, VP Quality, USA (Ref T-
    1161).
  106. Audio Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments
    Feedback:
    The seminar did exceed my expectations. It was a very good seminar and I learn more from it than from the published guides on the topic
    Mr. Jeff Wiser, Independant consultant, USA (Ref T-1159).
  107. Audio Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments
    Feedback:
    The seminar did exceed my expectations. The NIST definitions were new to me and were helpful in providing technical understanding. Seminar contained the information that I was looking for and more.
    Ms. Monika Roschlaub, Invensys Regulatory Compliance, Principal Consultant,USA (Ref T-1145).
  108. Audio Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments
    Feedback:
    The seminar did exceed my expectations. The presenter knew the topic very well, didn't just repeat what was on the slides. The flow of the presentation was excellent. Nice technical overview with smooth transition to regulatory requirements. Great seminar. I look forward to attending another one in the near future.
    Mr. David Fraser, 3M, QA Department, USA (Ref T-1141).
  109. Audio Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments
    Feedback:
    The seminar did exceed my expectations. Very straight forward responses with Yes or No answers to qestions. This may have been the best use of a training hour that I had in several years..
    Jerome Sauve, GE Healthcare, IT Compliance, USA (Ref T-1140).
  110. Audio Seminar: Comparing GLP with GMP
    Feedback:
    The presentation was very informative. I enjoyed the table layout. The visual made it easy to follow and use later for reference. This was very insightful
    Erica Schnars, BioAgilytix Labs, QA, Corporate Compliance Manager , USA (Ref T-1171).