Equipped to do Personnel Training
Posted by admin on May 8th, 2009He provides excellent in-house employee training in the areas of Chemistry, Manufacturing and Controls to Regulatory Affairs—CMC personnel. It seems that he is in a league of his own when it comes to his expertise in devising, amending and writing the Standard of Operating Procedures (SOPs) of the Regulatory Affairs. He has the ability to offer the most inclusive short course option for the CMC training professionals wherein his combined years of present industry knowledge along with a supreme capability to carry out information in a comprehensive and concise manner can really prepare the trainees in this field.
Furthermore, he makes it a point to stay on top of things just to make sure that the standardized procedures and languages are adhered and utilized by all CMC reviewers of drug application documents at all times. He has crafted and designed an effective program for personnel who are involved in the preparation of “Chemistry, Manufacturing and Controls” (CMC) section of a NDA or IND; however, for those personnel who are not part of the CMC document preparation but fancies an overall insight of what is involved for both the drug substance and drug product, his insights will definitely aid them as well.










































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