Scribd Logo
Upload

Welcome to Scribd!

  • GMP Master Training Sop: Fda Compliance Digest Published by Enkap

    Uploaded by

    vinaypharm
    251 views3 pages
    This document provides an overview of a GMP Master Training SOP that was published by enKap. The 13-page SOP establishes a training plan and system to ensure compliance with regulatory requirements. It defines necessary training for personnel, including qualifications for trainers. The SOP covers topics like a learning management system, new employee orientation, annual GMP training, SOP training, and documentation of training. It includes six attachments for documenting individual and group training. An excerpt of the SOP outlines requirements for training employees on new or revised SOPs relevant to their jobs before they can perform GMP functions. It describes how training will be initiated, documented, and managed for new SOPs and employees.

    Original Description:

    Original Title

    Training Sop

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document provides an overview of a GMP Master Training SOP that was published by enKap. The 13-page SOP establishes a training plan and system to ensure compliance with regulatory requirements. It defines necessary training for personnel, including qualifications for trainers. The SOP covers topics like a learning management system, new employee orientation, annual GMP training, SOP training, and documentation of training. It includes six attachments for documenting individual and group training. An excerpt of the SOP outlines requirements for training employees on new or revised SOPs relevant to their jobs before they can perform GMP functions. It describes how training will be initiated, documented, and managed for new SOPs and employees.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    251 views3 pages

    GMP Master Training Sop: Fda Compliance Digest Published by Enkap

    Uploaded by

    vinaypharm
    This document provides an overview of a GMP Master Training SOP that was published by enKap. The 13-page SOP establishes a training plan and system to ensure compliance with regulatory requirements. It defines necessary training for personnel, including qualifications for trainers. The SOP covers topics like a learning management system, new employee orientation, annual GMP training, SOP training, and documentation of training. It includes six attachments for documenting individual and group training. An excerpt of the SOP outlines requirements for training employees on new or revised SOPs relevant to their jobs before they can perform GMP functions. It describes how training will be initiated, documented, and managed for new SOPs and employees.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 3

    FDAComplianceDigest

    PublishedbyenKap

    byScottKnutson,CPLP This 13 page SOP includes includes over 150 individual procedural requirements related to the following: To describe the overall master training plan that establishes a system supporting compliance to regulatory requirements.

    GMPMasterTrainingSOP

    To ensure that the necessary training requirements are defined for personnel encompassing the education, training and/or experience required to perform their job successfully. To establish the method for documenting training, education and experience and all-training-related activities. Responsibility Section of the SOP includes the following subject matter content below: Learning Management System Training Curricula New Employee Orientation Annual cGMP Training SOP Training Learning assessments Documentation of Training Trainer Qualifications and much more GMP Master Training SOP includes six (6) attachments: Individual Training Documentation Form Group Training Documentation Form Learning Assessment Form Technical Training Protocol Training Equivalency Request Form Signature Record Form

    www.enkap.com

    FDAComplianceDigest

    PublishedbyenKap

    ARTICLE EXCERPT 7.5StandardOperatingProcedure(SOP)Training: 7.5.1EmployeesshallbetrainedonneworrevisedSOPsrelevantto theirjobposition,asdeterminedbytheirtrainingcurricula, andpriortoexecutingGMPfunctionsindependently.(Except forMinorRevisionsoutlinedinSection7.5.9) 7.5.2 SOPauthorsmustcollaboratewithTrainingOperationsto properlyidentifycurriculaassociatedwithidentifiedjobsin ELMtocreatetheappropriatetrainingpopulationtobeusedby theauthor. 7.5.3 Allchangestocurricula(neworrevised)mustbedocumented inaccordancewiththeappropriateSOP. 7.5.4 SOPTrainingistobeinitiateduponSOPapproval.Any employeewhohasnottrainedonanSOPpriortotheeffective dateisprohibitedfromperformingthefunction(s)outlinedin theSOP. 7.5.5 RevisedSOPsareapprovedonaweeklybasis.Uponapproval, thoseneedingtraininghaveoneweektocompletesaidtraining. Employeesnottrainedinsaidtimeperiodwillbedisqualified fromperformingthefunction(s)describedintheeffective SOP(s). 7.5.6 TheSOPauthor,itsreviewersandapproverswillautomatically begrantedcreditfortrainingupontheproceduresapproval. NOTE:QualityAssuranceapproverswillonlyreceivecreditfor QualityAssuranceprocedures. 7.5.7 NewandtransferredemployeeswillbetrainedonSOPsrelating totheirjobfunction,priortoperformingGMPwork independently.Whileintraining,theemployeesGMPentries mustbecosignedbyaqualifiedperson.

    7.5.8 SOPTrainingwillbedocumentedautomaticallyviaELM.In certainsituations,useofanIndividualTrainingDocumentation FormorGroupTrainingDocumentationFormmaybeused. Whenadocumentiscompleted,itwillbesenttoTraining Operations. ENDARTICLEEXCERPT www.enkap.com

    FDAComplianceDigest

    PublishedbyenKap

    This article excerpt is compliments of the FDA Compliance Learning Community of enKap (http://www.enkap.com). This article was published in its entirety in the July 2010 Issue of the FDA Compliance Digest . For more information on the FDA Compliance Digest please go to: http://www.enkap.com/page/fda-compliance-digest

    www.enkap.com

    You might also like