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Inspection Readiness For Computerised Systems

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  • čas přidán 16. 08. 2024
  • This video will help you to understand the keys of Inspection Readiness For Computerised Systems. How to ensure cGMP compliance with respect to computerised systems. This video will help to prepare for audits and successful audit results by different regulatory agencies for example FDA,PIC/S,WHO,EUGMP,TGA etc.
    This short video will help you to understand overall expectations about computerised systems from different regulatory agencies.LEARNINGPHARMACY.IN
    Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device,Compliance Insight

Komentáře • 13

  • @amolgaikwad9491
    @amolgaikwad9491 Před měsícem +1

    Good information

  • @proogamerop5266
    @proogamerop5266 Před 4 lety +1

    Thank you so much Sir, for such nice video

  • @rajathathireddy3285
    @rajathathireddy3285 Před 4 lety +1

    Hi sir, very good session.
    How to become a lead auditors, what are the requirements and skills.
    Can you pls take webinar on this.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Před 4 lety

      raja thathireddy Sure. First I will take free webinar on vendor evaluation and then I have to arrange paid webinar on Auditor qualification. As, this topic is required two complete days.

    • @rajumulakala5439
      @rajumulakala5439 Před 4 lety +1

      Iam also waiting for this topic.

    • @rajathathireddy3285
      @rajathathireddy3285 Před 4 lety +1

      @@hitendrakumarshah3718 Thank for your response and pls plan for paid webinar middle class peoples also affadable prise sir, therefore many peoples are able to reach your training.
      Iam aware We can't measure what are you are sharing the knowledge to people with money.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Před 4 lety +1

      Don't worry. I am with you.I will plan the seminar. Also, I will provide discounted rates if, you are personally paying the fees.

  • @rajumulakala5439
    @rajumulakala5439 Před 4 lety +1

    Dear Sir, what is the maximum allowable CEHT after equipment cleaned as per guidelines, just mention the reference document. Different organizations following different time as 4hr, 12hr, 24hr, 48hr, 126hr, among these which one acceptable.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Před 4 lety

      Hi, There is no such guide who states maximum CEHT. However, it is considered that, it should not be so large so justify the CEHT. and of course the CEHT should be based on scientific studied rationale.

  • @rajumulakala5439
    @rajumulakala5439 Před 4 lety +1

    Dear Sir, Entry of man and material have one way in production block is it acceptable or not , kindly reply with reference.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Před 4 lety

      I really not able to understand from your query. Do you mean that, the man and material entry and exit are different. Then yes. It is acceptable. as per WHO guide- Premises should be designed to ensure the logical flow of materials and personnel. Please confirm your question is related to what type of product?