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Dr. Ludwig Huber's Publications on Validation and Compliance

This site lists publications authored or co-authored by Dr. Ludwig Huber. They include text books, on-line tutorials, primers and journal publications.  Publications listed here without a name are solely authored by Ludwig Huber. If there are co-authors they are named with the publications.

 

Other training material from Ludwig Huber

Text Books

 

  • Validation of Computerized Analytical Systems
    Interpharm/CRC, 1995, ISBN 0-935184-75-9
  • Validation and Qualification in Analytical Laboratories
    Interpharm/CRC, 1998, ISBN 1-57491-080-9
    Second edition 2007, ISBN 978-0849-38267-3
  • Validation of Computerized Analytical and Networked Systems
    Interpharm/CRC, 2002, ISBN 1-57491-133-3

Online Tutorials

 

Primers

 

  • Good Laboratory Practice
    Hewlett-Packard, 1993, 152 pages
    Translated in about 10 different languages
  • Good Laboratory Practice and Current Good Manufacturing Practice
    Hewlett-Packard, 2004, 138 pages
  • Computer System Validation
    Labcompliance, 2006, 42 pages
  • Making the Best out of FDA Inspections
    Labcompliance, 2006, 72 pages
  • Using Macros and Spreadsheets in a Regulated Environment
    Labcompliance, 2003, 46 pages
  • Using Internet and Intranet in Regulated Environments
    Labcompliance, 2004, 22 pages
  • FDA/EU Compliance in Laboratories
    Labcompliance, 2006, 67 pages
  • Successful Compliance Training
    Labcompliance, 2004, 33 pages
  • Qualification of Networks and Validation of Networked Systems
    Labcompliance, 2004, 41 pages

Journal Publications

 

  • 21 CFR Part 11: Past, Present and Future
    Journal of GxP Compliance, 12, 22/37, October 2007
  • A Perspective on Computer Validation
    R. Budihandojo, L.Huber and others
    PharmTech, July 2007, On-line publication
  • Risk Based Validation of Commercial Off-the-shelf Computer Systems
    IVT Journal of Validation Technology, Vol 11 (3), 184/204, May 2005
  • Part 11 Is Not Going Away: The New Electronic Records Draft Guidance
    Wolfgang Winter and Ludwig Huber
    Biopharm International,  2003, VOL 16; NUMB 5, pages 28-35
  • Using the Internet in FDA Regulated Environment
    Pharmaceutical Canada, November 2004, 13/15
  • 21 CFR Part 11: The New Draft Guidance
    W. Winter and L. Huber,
    Pharmtech Europe, May 2003, 33-39
  • How to avoid FDA Warning letters (Chinese)
    Process China, April 2003. pages 28-31
  • Validation of Spreadsheet Applications
    Pharmaceutical Canada,  4(2) 11-13, 2003
  • 21 CFR Part 11 Compliance of Legacy Systems
    Pharmaceutical Canada,  3(3) 11-13, 2002
  • Supplement Biopharm
    Implementing 21 CFR Part 11, February 2004
    W.Winter and L.Huber,
    Part 1: 21 CFR Part11 - Requirements and New scope, 4-9
    Part 2: Getting a Handle on Access Security for 21 CFR Part11, 10-16
    Part 3: Data Integrity for Electronic Records According to 21 CFR Part 11, 18-20
    Part 4: Level-4 instrument Control - Why I't's Relevant for Part 11, 22-25
    Part 5: Qualifying Network Infrastructure - A Risk Based Approach, 28-31
  • Supplement Pharmaceutical Technology Europe
    21 CFR Part 11: Compliance and Beyond, March 2003, 40/45
    W.Winter and L.Huber, Instrument Control in Pharmaceutical Laboratories - Compliance with 21 CFR Part 11 and the New Draft Guidance
  • Implementing 21CFR Part 11 (Electronic Signatures and Records in Analytical Laboratories) in Analytical Laboratories.
    Seven Article Series authored by Ludwig Huber, Wolfgang Winter and Christoph Nickel, Supplement to BioPharm, 2001.
    Part 1. Overview and requirements 14/17
    Part 2. Security aspects for systems and applications 18/23
    Part 3. Ensuring data integrity in electronic records 24/27
    Part 4. Data migration and long-term archiving for ready retrieval 28/33
    Part 5.: The importance of instrument control and data acquisition 34/38
    Part 6. Biometrics-Based Authentication - Limitations and Possibilities 40/43
    Part 7. Making legacy systems compliant 44/47
  • Validation and Qualification of Networked Systems.
    Ludwig Huber and Rory Budihandojo, R&D IT Manager at GSK
    Biopharm, October 2001, 18-28 and 46-47
    Download from the LabCompliance User Club
  • Electronic records and signatures in practice
    Pharmaceutical Canada, (1) 18-22, 2000
  • Importance of Instrument Control and Data Acquisition in Pharmaceutical Laboratories: Compliance with 21 CFR Part 11
    L.Huber and W.Winter, PharmTech Asia, April 2001, 24-29
  • The Future State of Computer Validation
    Increasing the Efficiency of Computer Validation Practices
    R.Budihandojo, L.Huber and others
    Part 1. Pharmaceutical Technology, Vol 25 (7), July 2001, 86/93
    Part 2. Pharmaceutical Technology, Vol 25 (9), Sep 2001, 50/60
  • Qualification of Equipment and Computerized Systems
    Pharmaceutical Canada, Vol 2, Number 3 (July 2001), 17/20.
  • 21 CFR Part 11 Compliance for Pharmaceutical Laboratories: A Supplier's Perspective
    L.Huber and C.Nickel, Laboratory Focus, March 2001, 12/14
  • Importance of Instrument Control and Data Acquisition in Pharmaceutical Laboratories for 21 CFR Part 11
    L.Huber and W.Winter, PharmTech Europe, January 2001, 48-54.
  • Impact of Part 11 on Chromatography Data Systems
    L. Huber, W. Winter, ,GMP Journal, Vol 5, Oct 2000, 31-39
  • Support from Instrument Vendors for Compliance
    The International Pharmaceutical Review 2000, ICH Conference Edition, October 2000.
  • Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories
    Part 1: Requirements and Overview, Biopharm 12(11), 28-34, 1999
    Part 2: W. Winter and L. Huber, Security aspects for systems and applications, BioPharm 13(1) 44-50, 1999
    Part 3. W. Winter and L. Huber, Ensuring Data Integrity of Electronic Records
    BioPharm, 13 (3), 45-49, March 2000.
    Part 4. Data Migration and Long-term Archiving for Ready Retrieval,
    Biopharm  13 (6), 58-64, June 2000

    Part 5. W. Winter and L. Huber, Importance of Instrument Control and Data Acquisition
    Biopharm  13 (9), 52-56, Sept 2000
    Part 6: W. Winter and L. Huber, Biometrics-Based Authentication - Limitations and Possibilities
    Biopharm  13 (11), 26-30, Nov 2000
  • Preparation and Qualification of Certified Reference Material and Working Standards
    BioPharm, Vol. 12, Number 6, June 1999, 84/85
  •  In Search of Standard Definitions for Validation, Qualification, Verification, and Calibration
    BioPharm, Vol 12 Number 4, April 1999, pages 56/58
  • Qualification of High-Performance Liquid Chromatography Systems
    BioPharm, Vol 11 Number 11, November 1998, pages 41 and 65/66
  • Validation of Analytical Methods: Review and Strategy
    LC/GC International, February 1998, 96-105
  • Equipment Qualification in Practice
    LC/GC Magazine, Vol 16, February 1998, 148-156
  •  How an Instrument Vendor Helps with Accreditation and ISO Certification,
    Accreditation and Quality Assurance, 1999, 4, 87-89 , 1999, 4, 87-89 , 1999, 4, 87-89
  • Validation of Standard Methods, 'Analytical Validation Supplement to Pharmaceutical Technology', February 1998, 6-8.
  • Validation of HPLC Methods
    Biopharm, 12 (3), 64-66 , 1999
  • Analytical System Validation and On-going Performance Control, Published by 'Pharma, BioPharma & Nutraceutical Directory, Canada', January 1998
  • L. Huber and L. Welebob, Selecting Parameters and Limits for Equipment Operational Qualification, Accreditation and Quality Assurance, 2 (7), 316/322 (1997)
  • L. Huber and H. Wiederoder, Qualification and validation of software and computer systems in laboratories. 4 Part Publication in Accreditation and Quality Assurance
    Part 1: Validation during development,
    'Accreditation and Quality Assurance', Vol 2 (8) Dec 1997, 360-366
    Part 2: Qualification of the vendor
    'Accreditation and Quality Assurance', Vol 3 (1) Jan 1998, 2-5
    Part 3: Installation and Operational Qualification
    'Accreditation and Quality Assurance', Vol 3 (3) April 1998, 140-144
    Part 4: Evaluation and validation of existing systems
     'Accreditation and Quality Assurance', Vol 3, (5) June  1998, 261-264
  • L. Huber, Validating Computerized Analytical systems, LC/GC magazine,
    Series of five articles, June 1996 to January 1997.
    Part 1: Overview, Regulations and Terminology,
    LC-GC magazine, 14 (6), 502/508, 1996 and LC/GC Interntnl September1996, 564/572
    Part 2: Setting specifications, qualifying a vendor and validating user-contributed application software";
    LC-GC Magazine 1996, 14(7), 592/594 and LC/GC Interntnl October 1996, 666/669
    Part 3: Installation and operational qualification";
    LC-GC Magazine 1996, 14(9), 806/812 and LC/GC Interntnl December 1996, 794/799
    Part 4: Ensuring ongoing performance";
    LC-GC Magazine 1996, (10), 896/900 and LC/GC Interntnl May 1997, 300/308
    Part 5: Retrospective evaluation and validation
    LC-GC Magazine 1997, (1), 54/58 and LC/GC Interntnl June 1997, 374/380
  • L. Huber and M. Thomas, Validating computer controlled analytical systems
    in the pharmaceutical laboratory,
    LC/GC Magazine, June 1995, 466/473, LC/GC Interntl. October 1995, 572/580
  • Validation of Analytical Methods: Review and Strategy
    LC/GC Magazine, July 1997
  • L.Huber and L.Welebob,
    Selecting Parameters and Limits for Equipment Operational Qualification,
    Submitted to Accreditation and Quality Assurance, 1997
  • L. Huber and K. Mandelatz, Laboratory Accreditation,
    Part 1: Overview and situation in Europe,
    International Laboratory, October 94, 19/21,
    American Laboratory, November 1994, 45-47
  • L. Huber and J.A. Rogers, Laboratory accreditation,
    Part 2: Preparing and implementing accreditation,
    International Laboratory, March 1995, 10/12
  • Laboratory accreditation,
    Part 3: Validation and calibration of equipment,
    International Laboratory, September 1995, 9/12
  • L. Huber and R. Perissi,
    Accreditation processes and procedures in Europe and in Italy,
    Biologi Italiani, April 1995, 11/14
  • Validation of analytical instruments and methods
    Biologi Italiani, May 1995, 10/15
  • Internal and external quality control in analytical laboratories,
    Biologi Italiani, June 1995, 6/9.
  • Quality assurance and instrumentation,
    Accreditation and Quality Assurance, 1 (1), 24/34 (1996)
  • Validation of computerized systems in pharmaceutical laboratories,
    Pharmind - die pharmazeutische industrie, 58/10, October 1996, 935/940, (in German)
  • How an instrument vendor helps with accreditation,
    ILAC Newsletter, January 1995, page 3