First International GLP Award from Indian Drug Manufacturer
On September 17, 2000, Ludwig Huber, worldwide product
marketing manager of Agilent..... Technologies and editor of
Labcompliance, received the First International GLP award
for his research and publications on GLP and GMP from the
Indian Drug Manufacturer Association (IMDA). The winner has
been a selected by a committee of members from the Advisory
Board of IMDA
||Dr. Ludwig Huber
from Agilent Technologies received IDMA's First
International GLP Award from the president Mr. Isran
- About 120 delegates from pharmaceutical industry and
testing laboratories from all over India attended the award
celebration in Mumbai on Sept 16, 2000.
- Dr. Ludwig Huber from Agilent Technologies presented as
key note address: "Recent Developments and Trends in US FDA
and International GLP/GMP and other Regulations".
- The presentation started with mega trends, international
harmonization efforts through the ICH and OECD and new
contents of the updated US cGMP regulations.
- After that Ludwig Huber went into details about
contents, consequences and inspection and enforcement
practices of the US FDA draft guidelines on Handling Out of
Specification situations (OOS) and FDA's 21 CFR Part 11 on
Electronic Records and Signatures.
- He specifically discussed activities and anticipated
results of Part 11 task forces of the US FDA, the Industry
task force PDA and the GAMP forum.
- At the end Dr. Huber thanked the IDMA for the
"International GLP Award" and donated the IDMA copies of his
two validation reference books "Validation of Computerized
Analytical Systems" and "Validation and Qualification in
presenting the key note address
||All IDMA award
winners together with the organization committee. Main
attraction was Ludwig Huber with flowers in the middle.
donating his two validation reference books to Mr.
Sipahilanami for the IDMA
||Ludwig Huber has
been interviewed by two journalists.
They asked him about his view on positioning of Indian
Pharmaceutical industry in global market place.
celebrating this success in a fine restaurant with his
favorite colleges and friends from Agilent India, Sanjev
Dhar and Ganapathy Ramakrishnan (Rama, right), country
manager of Agilent India