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Biography

Achievements

  • Author and editor of www.labcompliance.com, the leading global online resource for validation and compliance in laboratories.
  • Was responsible for the worldwide FDA compliance program at Hewlett Packard and Agilent Technologies. Hewlett-Packard and Agilent have been ranked several times as number one supplier for compliance in analytical instrumentation
  • Was responsible at Agilent Technologies for Worldwide Product Marketing of HPLC and Pharmaceutical Solutions. During that time Agilent's 1100 Series HPLC became the best selling HPLC in the world.
  • Author of Labcompliance Best Practices "21 CFR Part 11 Compliance Package"
  • Author of the three validation reference books from Interpharm/CRC: "Validation of Computerized Analytical Systems", "Validation and Qualification in Analytical Laboratories", and "Validation of Computerized Analytical and Networked Systems", Interpharm Press, 1995, 2007 and 2002. Best sellers at Interpharm.
  • Did hit the record of Agilent's Video Webseminars with more than 2000 registrations: Title "Analytical Instrument Qualification According to USP <1058>.
  • Author of Labcompliance Best Practices: "Network Quality Package" and "Validation Master Plan"
  • Author of Labcompliance Best Practices "Macro and Spreadsheet Quality Package"
  • Author of Labcompliance Best Practices "FDA Inspections" and "Risk Management Master Plan"
  • Author of "GLP and cGMP in Analytical Laboratories", with more than 130 000 copies distributed
  • Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
  • Consultant for the industry and regulatory agencies on compliance issues.
  • Did hit the record of IVT's tele-seminars with more than 180 registrations: Title "Analytical Instrument Qualification According to USP <1058>.
  • Member of the US PDA task force on 21 CFR Part11,
  • Member of the GAMP America, special interest group: lab equipment
  • Member of IVT task force 2003: IT Infrastructure&Network Qualification
  • Member of scientific advisory board of IVT's GxP Journal
  • Board member of 21CFRPart11 Compliance - Newsletter
  • Board member of Pharmaceutical Technology Europe
  • Member of the advisory board for the European Compliance Academy (ECA)
  • 'Presenter of Year' selected by thousands of IVT conference attendees.
  • Winner of the Wallhaeusser award, sponsored by the European Compliance Academy for award for publications in the area of 'Quality and Safety of Drugs'  
  • Presenter of six interactive videos: "21 CFR Part 11", "Validation of Analytical Methods", "Validation of Computerized Analytical and Networked Systems", "Validation and Qualification in Analytical Laboratories", "Validation and Qualification of Networks and Networked systems" and "Using Macros and Spreadsheets in a Regulated Environment"
  • Presenter of the 2004 Video Web Seminar: Risk Based Validation of Laboratory Systems with more than 1500 attendees
  • Presenter of the 2006 Video Web Seminar: Analytical Instrument Qualification (USP 1058) with more than 2000 attendees
  • Presenter or more than 150 live on-line audio/tele/video seminars.

Biography

Ludwig Huber has studied chemistry and received his Ph.D. from the University of Karlsruhe, Germany. He has been working for Hewlett-Packard and Agilent Technologies as applications chemist, product manager and marketing manager for several analytical instruments.  As Agilent's Worldwide Compliance Fellow he also was reponsible for the FDA and ISO 17025 compliance. He has published more than 100 papers on validation and compliance and 21 CFR Part 11 and is the author of several books, such as Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems. He is also the author and editor of www.labcompliance.com the on-line resource for validation and compliance issues in laboratories. Dr Huber has been a member of the PDA Task Force on 21 CFR Part 11 and of the GAMP Special Interest Group on Laboratory Equipment and currently he is on the advisory board of the European Compliance Academy and was a member of the IVT task force on network qualification.

About myself

Some people may think I am an IT specialist or a QA person because most of you know me from my presentations and publications on GLP, GMP, and validation of computer systems. However, I am just a chemist. Even I have to admit that I lost most of my scientific knowledge, I still think as a chemist !
I received my Master of Science in Chemistry in 1975 and my Ph.D. in Chemical Engineering in 1978 from the University of Karlsruhe, Germany.
By far the most important and most lucky step in my professional life was to join HP's Chemical Analysis Group (now part of Agilent Technologies) in 1978. I started as an Applications Chemist for Gas Chromatography. I have been working for Hewlett-Packard and Agilent was very happy to be an employee of this excellent companies. What I like most ws the freedom to do what I wanted, as long as my customers are happy with me. I also appreciated the continuous support of my managers, especially Dr. Guenter Nill.

One of my key previous positions was Worldwide Product Marketing Manager for HPLC products and environmental and pharmaceutical industry markets at Hewlett-Packard and Agilent Technologies. Amongst other products I was responsible for the very successful 1100 Series HPLC, at that time probably the world's most frequently sold HPLC modules and systems.

Since 2008 I have been entirely focusing on providing compliance expertise to industry, testing laboratories and to regulatory agencies all over world. I am doing this through public conferences, targeted on-site seminars, audio- and web seminars, but also through on-line newsletters, books and video seminars,.

Taipei, World Trade Center at signing one of my books. 

As part of my job as Product Marketing Manager for the pharmaceutical industry at Agilent technologies I spent quite some time to find out what our customers need to meet regulatory requirements. Together with colleagues from R&D, marketing, quality assurance, from other HP divisions and from our sales and service organizations we developed products and services to meet these requirements.

I am writing a lot! I am the author of more than 100 publications dealing with GC, HPLC and regulatory and quality standard compliance in the analytical laboratory.

At the beginning of my professional live I focused on special techniques in gas and liquid chromatography. For example, I wrote, contributed to and edited the books 'Applications of Diode-Array Detection in HPLC' (1990), published by Hewlett-Packard, 'Diode-Array Detection in HPLC' (1993) and 'HPLC in Pharmaceutical Industry', (1992), published by Marcel Dekker

Later on I specialized in GLP, GMP and Accreditation. In this area I wrote the book 'Good Laboratory Practice and Good Manufacturing Practice for HPLC, GC, MS, CE and UV/Vis Spectroscopy', published by Hewlett-Packard in 1994. Meanwhile the book has been translated into ten languages and over 130,000 copies have been distributed, mainly to the pharmaceutical industry.

The book 'Validation of Computerized Analytical Systems' published by Interpharm in May 1995 became Interpharm's number one bestseller in 1996. The second book is entitled 'Validation and Qualification in Analytical Laboratories'. It has been published in November 1998 and became 'THE Standard reference book on validation and qualification in analytical laboratories'. The most recent publication is the book entitled 'Validation of Computerized Analytical and Networked Systems'. It has been published in April 2002 and has the potential to become 'THE Standard reference book on computer validation and part 11 compliance for analytical laboratories'. Currently I am working on a new edition of the book 'Validation and Qualification in Analytical Laboratories' for publication in 2007.

Since 2002 I have been developing complete compliance solutions on specific topics such as network qualification, risk assessment, FDA Inspections, for laboratory compliance, for Part 11 compliance, for Computer System Validation and spreadsheet compliance such as Excel. Solution elements include video presentations and primers to get a good understanding and SOPs, checklists, templates and examples for easy implementation. They are available from the Labcompliance book shop.

I am traveling a lot ! I give presentations mainly on GLP/GMP, 21 CFR Part 11, ISO 17025 and Validation around the world. I prepared and mostly presented Hewlett-Packard's and Agilent's popular seminar series on 'Validation in the Analytical Laboratory - to meet regulatory and quality standard requirements'. The series has been presented world-wide in more than 30 countries to more than 10,000 attendees. Copies of the slides have been distributed by the World Health Organization (WHO) in preparation for the development of new validation guidelines.

I have been sharing and/or still share my expertise with different organizations. They include: International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), US FDA (United States Food and Drug Association), Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), Indian Drug association, the European Compliance Academy (ECA), and the Institute for Validation and Technology (IVT), and others.

Most recently I share my experience in on-line audio seminars. These are one hour seminars delivered over the telephone. Topics are basics of compliance like FDA Inspections, SOPs, Master Plan, Change Control, CAPA and selected new topics like various aspects of risk analysis. The real value of these seminars comes from the handout material. This includes 10+ documents like SOPs, examples, templates, checklists, reference papers and regulatory documents. So far I have delivered over 120 such seminars.