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  • 1.  21 CFR 211 and 820 cGMP training requirement

    Posted 20-Sep-2012 03:45
    Hi,

    I just became a RAPS member a couple of weeks ago and I need some advise from the RAPS community.

    My company is manufacturing drug and medical device and we are located in Asia.

    Under 21 CRF part 211 and 820, it stated that the employees need to undergo yearly gmp training.

    We had an inspection last month and the inspector informed us that our training is insufficient.

    Can anyone tell me what sort of training program will satisfy US FDA requirements on 211 and 820?

    Best regards,

    Ethan


  • 2.  RE:21 CFR 211 and 820 cGMP training requirement

    Posted 21-Sep-2012 06:41
    There is long list of items that needs to be covered in training. You do a Google search using GMP Training and you will get an idea. Essentially training should cover all aspects of GMP. One example after Google search is available at: http://www.cfpie.com/CfPIE-Course-Catalog-2012.pdf (This is not an endorsement of this company in any way). 

    Wajeeh
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    Wajeeh Bajwa
    Director Regulatory Knowledge and Research Support Program
    University of Florida
    Gainesville FL
    United States
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    Original Message


  • 3.  RE:21 CFR 211 and 820 cGMP training requirement

    Posted 23-Sep-2012 19:50

    Another good FDA training site is http://www.fda.gov/training/cdrhlearn/default.htm.
    It gives you pesentations (webinars) on all kind of topics and include an exam and ability to get a certification.
    Th lectures are available also oin Chinease
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    Varda Swery
    Signostics Ltd
    Torrensville
    Australia
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    Original Message


  • 4.  RE:21 CFR 211 and 820 cGMP training requirement

    Posted 21-Sep-2012 08:06
    Hi Loh, The answer depends on the complexity of your device. This website should give you the minimum requirements for FDA perspective. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122447.htm You should determine who should be trained and what they would be trained in. For instance if you are purchasing. A raw material that has some specifications that will be used in the manufacturing process of your device. Everyone involved in the purchasing of the raw material should be trained. This may include someone like an office manager that places the order to the wharhouse professional that moves and stores the material. The type and content of the training depends on the job description, a worker responsible for transport and storage may not have to be trained in sterilization procedures. Training is there to help your comply with law. Hope this helps for more help also contact DESMICA at FDA they are very helpful. DSMICA - Contact Us You may contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at CDRH via email, telephone or fax. Email: dsmica@fda.hhs.gov or industry.devices@fda.hhs.gov Telephone: 1-800-638-2041 or 301-796-7100 Follow the prompts: For Consumer Questions - press 1 For Industry Questions - press 2 Fax: 301-847-8149 DSMICA can assist you with questions on a variety of topics including the following: 510(k) - Status of Submission 510(k) - Premarket Notification Adverse Events Reporting including Medical Device Reporting (MDR) Accredited Persons/Third Party Review and Third Party Inspection Biocompatibility Bioresearch Monitoring Program (BIMO) Classification of Medical Devices Consumer Assistance Corrections and Removals Design Controls/Pre-production Quality Assurance Electronic Products Radiation Control Establishment Registration / Medical Device Listing Export Requirements Global Harmonization Activities Good Clinical Practice (GCP) Good Laboratory Practice (GLP) Guidance Documents and Publications Good Manufacturing Practices (GMP) / Quality Systems Harmonization By Doing (HBD) Import Requirements In Vitro Diagnostic (IVD) Products Inspections of Medical Device Establishments Investigational Device Exemption (IDE) Labeling Premarket Approval (PMA) Postmarket Studies Quality Systems/Good Manufacturing Practices (GMP) Recalls Regulations Regulatory Requirements to Market a Medical Device Reprocessing of Single Use and Multiple Use Devices Risk Communications Small Business Determinations (SBDs) Standards Summary Technical Documentation (STED) Tracked Devices User Fees Hope this helps Best Shree ------------------------------------------- Srinagesh Koushik RAC Damascus MD United States -------------------------------------------
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