AUTHOR
Dr. Ludwig Huber Chief Advisor for Global FDA Compliance, Labcompliance ludwig_huber@labcompliance.com
Dr. Ludwig Huber is the editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr. Huber’s website www.ludwig-huber.com.
Introduction
The mission of the United States Food and Drug Administration (FDA) and equivalent international agencies is to protect consumer health and safety under the Federal Food, Drug, and Cosmetic Act or equivalent international laws. The agencies have developed two basic strategies towards this mission:
• Monitoring the quality of products through surveillance activities such as sampling and analyzing products in distribution.
• Evaluating through factory inspections the conditions under which products are developed, manufactured, tested, packed, labeled, and held.
Read the article :
https://sites.google.com/site/pharmaqclabs/articles
Dr. Ludwig Huber Chief Advisor for Global FDA Compliance, Labcompliance ludwig_huber@labcompliance.com
Dr. Ludwig Huber is the editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr. Huber’s website www.ludwig-huber.com.
Introduction
The mission of the United States Food and Drug Administration (FDA) and equivalent international agencies is to protect consumer health and safety under the Federal Food, Drug, and Cosmetic Act or equivalent international laws. The agencies have developed two basic strategies towards this mission:
• Monitoring the quality of products through surveillance activities such as sampling and analyzing products in distribution.
• Evaluating through factory inspections the conditions under which products are developed, manufactured, tested, packed, labeled, and held.
Read the article :
https://sites.google.com/site/pharmaqclabs/articles
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