Peak Pharmaceutical Organization FDA Audit Knowledge Training

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In order to enhance the understanding of FDA certification and prepare for the certification of international projects, on February 14 and 16, Jianfeng Pharmaceutical Company specially organized the whole staff of Manufacturing Department II to carry out FDA audit process sorting and simulated audit question and answer sharing training.

In order to enhanceFDAUnderstanding of certification, preparation for certification of international projects,2Month14day,16On the day, the peak pharmaceutical company specially organized the manufacturing department 2 to carry outFDAAudit process combing and simulation audit question and answer topic sharing training.

    The sharing was made by Wang Bihu, Quality Director of Peak Pharmaceuticals, who has the product of external enterprises.FDAThe audit inspection is a case study, giving the entire staff a clear and detailed presentation of the period.5The day's audit checks the process and events that occur during 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 process of inspection, they should pay special attention to their own post cognition, do not make subjective guesses and judgments, keep the contents of the answers before and after, and do not need to be too nervous.SOP,SMPThe content of the procedure is based on the content of the procedure, and the audit inspection can be handled calmly. The development of this training has strengthened the staff's understandingFDAThe awareness of the inspection enhances the confidence of the staff to win the inspection.