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    Home > Medical News > Latest Medical News > Difficulty analysis of live MAH on-site inspection and precautions for welcome inspection

    Difficulty analysis of live MAH on-site inspection and precautions for welcome inspection

    • Last Update: 2021-07-20
    • Source: Internet
    • Author: User
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    3.
    Analysis of the key points and difficulties of the commissioned production MAH inspection by the National Bureau and the provincial bureaus;


    4.
    Preparation and precautions for on-site inspection of commissioned production (R&D) MAH
    .


     Lecturer profile

    Li Hongye

    Training Lecturer of China Food and Drug Administration

    Lecturer of Master's Program in Pharmaceutical Engineering


    General Manager of Beijing Honghuilai Technology Co.
    , Ltd.
    , former external lecturer of SFDA Training Center; full-time lecturer of GMP course of Tianjin University Pharmaceutical Engineering Master Class
    .
    GMP lecturer in the Master's Program of the Institute of Materia Medica, Chinese Academy of Medical Sciences
    .
    Standing member of the Pharmaceutical Technology Professional Committee of China Medical Education Association
    .
    Expert in the pharmacy expert bank of the Expert Committee of China Medical Education Association
    .
    GMP training instructors of many provincial and local bureaus
    .


    20 years of European and American medical regulations, DMF and CEP document preparation, FDA, CEP on-site cGMP and EU GMP compliance inspection services work experience, including China's new version of GMP certification; cGMP compliance research senior expert, consultant
    .
    Experience in on-site inspection of more than 100 official GMPs in China, the United States, FDA, Europe, Japan, South Korea and other domestic and international official GMPs, and experience in writing APIs for APIs (COS/CEP certificates) and DMF documents for more than 100 products
    .


    MAH boutique series of courses (5 sessions)


    Zhiyao Business School-Knowledge Sharing Ecosystem in the Pharmaceutical Industry


    The construction and continuous improvement of the pharmaceutical industry system promotes the continuous knowledge update and technological iteration of the pharmaceutical industry, and also promotes the urgent need for lifelong learning among pharmaceutical professionals
    .


    Relying on the rich experience and deep resources accumulated over the past ten years on the website platform, Pharmonline integrates resources for the existing conference products "Pharmaceutical Master Talk", "CPhI Pharmaceutical Training+", and "CPhI Lectures".
    At the same time, it is aimed at companies gaining customers in foreign trade.
    According to the demand, the new foreign trade training course "7-point classroom" was promoted and upgraded to "Intelligent Medicine Business School"
    .


    As a professional conference and course provider, "Smart Medicine Business School" will create social, learning, and sharing scenarios for the majority of pharmaceutical industry professionals, and build an ecosystem of knowledge sharing in the pharmaceutical industry
    .


    Course consultation : Ms.
    Zhang


     Phone : 021-33392443


      Email : Carina.
    Zhang @imsinoexpo.
    com


    Business Sponsor : Ms.
    Shen

      
    Phone : 021-33392534


       Email : miranda.
    shen@imsinoexpo.
    com

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