Home | Contact | Books | Audio | Usersblub

First International GLP Award from Indian Drug Manufacturer Association

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 Analytical
Ludwig Huber presenting the key note address
All IDMA award winners together with the organization committee. Main attraction was Ludwig Huber with flowers in the middle.
Ludwig Huber 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.
Ludwig Huber 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