CGMPs, GLPs and US FDA Inspection

Venue: mumbai

Location: mumbai, India

Event Date/Time: Mar 19, 2007 End Date/Time: Mar 22, 2007
Registration Date: Jan 31, 2007
Early Registration Date: Dec 15, 2007
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CGMPs, GLPs and US FDA Inspection - a 3-day open-enrollment training seminar will be organized by ONCO Life Sciences in collaboration with SPI USA, Baltimore USA from 19th -21st March’2007 at Mumbai, INDIA

The lectures will be delivered by a team of speakers lead by Dr. António Moreira an experienced consultant as well as a long-term academician.

Dr. Moreira’s main area of expertise is in biochemical engineering. His experience includes basic research, process R&D, facilities design, and operation, validation of facilities and processes, and regulatory compliance. He has also extensive experience with compliance with the current Good Manufacturing Practices regulations of the US FDA.
Broad focus areas of the training seminar include:

GLPs for the Biopharma Industry from a U.S. Perspective including Introduction to the FDA ,Overview of the science of GLP,GLP Laboratory Organization & Function ,GLP Facilities - Design and Qualification , GLP vs. GMP, GCP , GLP Documentation, Laboratory Deviations and Out of Specification Results, Testing/Laboratory SOPs & Audits.


CGMP Regulations for the Biotech/Pharma industry from a U.S Perspective including CGMPs and the FDA ,CGMP Documentation, Prevention of Contamination , Fundamentals and Essentials of Validation , Controls , FDA Inspections and Investigations , International CGMPs , Recent FDA Developments such as electronic Records & Signatures- 21 CFR 11.

Day 3:

Handling US FDA Inspections, Steps in the FDA inspection process, Biotechnology topics covered during an inspection, Top 10 FDA citations, FDA 483s, Legal actions, Consent decree, License renovation, in-house & vendor audits