Peak Pharmaceutical Organization FDA Audit Knowledge Training
Release time:
2023-02-22
News from our newspaper In order to improve the understanding of FDA certification and prepare for the certification of international projects, # June 14 and 16 , Jianfeng Pharmaceutical Company specially organized the manufacturing department 2 to carry out FDA audit process sorting and simulated audit question and answer sharing training.
This sharing was given by Wang Bihu, Quality Director of Jianfeng Pharmaceutical. He took the FDA audit inspection of foreign enterprise products as a case and clearly and detailedly showed the whole staff the 5 -day audit inspection process and the events that occurred in the process. He also put forward audit questions from the auditor's perspective, such as closed, open, I don't understand, theoretical, silent question, I am an expert, etc., so that the trainees can further understand how to make the best response when being asked in different situations.
Vivid sharing training, so that employees understand that in the inspection process, they should pay special attention to their own job cognition, do not make subjective guesses and judgments, keep the content of the answers before and after, and do not need to be overly nervous. They should be based on the content specified in SOP and SMP procedures and calmly deal with the audit inspection. This training has strengthened employees' awareness of the FDA inspection and enhanced their confidence in winning the inspection. (Li Beibei)
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