Ludwig Huber - IVT's Presenter of the Year

On November 5, Ludwig Huber, worldwide product marketing manager of Agilent Technologies, received the Industry Award 'Presenter of the Year' from the Institute of Validation and Technology, the leading global publisher and probably by far the best conference provider for validation and compliance.

This award has been presented by Glenn Melvin, president of IVT, during a special awards banquet in the historical Rosegarden ball room of the Hyatt Hotel in Philadelphia. Throughout 2002, Ludwig Huber gave 14 presentations at IVT's conferences in North America, Europe and Japan.

 

As Glenn Melvin said, "Ludwig Huber dominated the scores of all presentations he was presenting at". The presentation on network qualification was attended by 320 people and had the highest score in the history of IVT conferences. Other presentations included topics like FDA and EU regulations, e-records management, risk assessment, various aspects of computer validation, contributions of vendors, using the internet in a regulated environment and using macros and spreadsheets in a regulated environment.

 

Glenn Melvin gave four reasons for the overwhelming success of the presenter:

1. Using excellent reference material through the Labcompliance website. They include SOPs, checklists and Internet references.
2. Using most modern multi-media presentation tools like video clips with FDA officials.
3. Giving clear step-by-step directions on how to implement the regulations and guidelines rather than spending time on theory.
4. Humor. Glenn gave an excellent example for the humor citing his multiple answers to the question 'how much testing is enough' during a network infrastructure conference

Competition for the award

The competition for this award included 165 presenters. They came from the pharmaceutical industry, industry task forces and from the US FDA

IVT and it's conferences

IVT is dedicated to validation and compliance mainly for FDA and other regulations related to the pharmaceutical industry. The organization publishes journals and books and organizes highly professional conferences around the world.

• Typically, 90% of conferences attendees come from the pharmaceutical and medical device industry.
• They are mainly managers and other professionals from development and manufacturing departments, but also from IT and QA departments and from analytical development and QC laboratories.
• For example, about 60% of the conference attendees on Network Infrastructure Qualification were IT professionals.

For more information on the publications, journals and books of the Institute of Validation and Technology (IVT) go to the IVT website.

Ludwig Huber's presentation titles at IVT conferences

1. Using the Internet in a Regulated Environment
2. Validation of Networked Systems in a CNI qualified environment
3. How to Apply FDA's Recent Part 11 Interpretations and Validation Guidance to Analytical Laboratory Computers
4. Qualification of network infrastructure and validation of networked systems
5. Using Macros and Spreadsheets in Regulated Environment
6. Design and validation of a chromatographic data system for compliance with 21 CFR Part 11
7. Response of the Pharmaceutical Industry in Europe and in United States to 21 CFR Part 11
8. Understanding and implementing Recent Part 11 guidance documents
9. Part 11 Compliance with Audit Trail Requirements of Part 11
10. Operational Compliance for Legacy Systems
11. Validation and Qualification of Networks and Networked Systems

More Photos

 

	Network Infrastructure Qualification, Philadelphia, October 9, 2002 with more than 300 attendees With an average score of 4.65 out of 5, this presentation was ranked as the 'best' in the long history of all IVT conferences.
	Network Infrastructure Qualification Philadelphia, October 9, 2002 Ludwig's presentations on network and internet compliance were supported through video clips with FDA officials, here Paul Motise

Computer Validation and E-Records &Signature Conference, Washington, April 22, 2002 Ludwig Huber  in the Hilton's VIP Speakers' Lounge with Paul Motise from the US FDA (middle) and Jay King from J&J (left).

	Ludwig presenting a workshop on Network Qualification & System Validation at the Washington CVS/ERES&ESIG Conference.. Ludwig's workshops had the highest attendance in 2002, here more than 100 professionals. April 23,2002
	IVT also took the conference on CSV and E-Records&  and Signatures to Japan The slides were shown on two screens in English and Japanese. Ludwig Huber gave six presentations out of 24 in total. Tokyo, February 26, 2002

	This IVT conference dinner in Tokyo has been sponsored by YAN/Agilent Technologies February 26, 2002
	Glenn Melvin, president of IVT, opens conferences. Here at the CSV/ E-SIG&Records conference in Washington. Glenn is also the editor of IVT's popular GxP and Validation Journals. Washington, April 28, 2002

	Paul Motise from the US FDA is a regular presenter at IVT conferences. Here at the CSV/E-SIG&Records conference in Washington. He explained FDA's Part 11 Guidance documents. Washington, April 28, 2002
	The Dublin Conference CSV/E-Records& Signatures was attended by about 250 professionals, mainly from the pharmaceutical industry Ludwig spoke about validation of lab computers, networks and spreadsheets. Dublin, Ireland September 24, 2002
	Ludwig with his wife Maria and son Philipp at the Awards Banquet in the Rosegarten of the Philadelphia hotel. Philadelphia, Nov 5, 2002
	Ludwig Huber thanking IVT conference delegates and IVT for the award. Special thanks went to John Kirchner of IVT for excellent conference organizations. Philadelphia, Nov 5, 2002
	Ludwig Huber with Kristen Evans, Investigative Engineer, U.S. Food and Drug Administration Kristen gave a presentation entitled: "FDA Inspections and Trends Related to Pharmaceutical Validations"
	Ludwig with John Kirchner, Vice President and Director of IVT's conference division. John is the driving force behind the overwhelming success of IVT's conferences.  His creativity and innovation keeps IVT's validation& compliance conferences ahead and ensures attendees to stay on top of ever changing regulations and guidelines  It's a pleasure to work with him.
	IVT's Casino Nights after long working days are very popular amongst conference attendees. One 'little detail' how IVT cares about customers. Here Ludwig playing "Black Jack" with his sun Philipp (right) during the Validation Week in Philadelphia Philadelphia, Nov 4, 2002

 

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