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
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- Part 11 Is Not Going Away: The New Electronic Records Draft
Guidance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- 21 CFR Part 11: The New Draft Guidance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