cGxP

Consulting

 

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4: Customized Regulatory or Technical Training
 
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    Based upon QSIP
    Train scientific, engineering, quality and manufacturing, and related staff at all personnel levels.
    Training specifically designed to new procedures
    Encourage exchange of ideas using active participation “adult education” approach
     

    cGxP has existing training courses which have been well received by Fortune 500 companies.  Our forte is designing and delivering very effective training on all of the subjects below.  We offer specialized adult training and adult educational services directed at all employees' levels as related to regulatory issues. This training is tailored to the organization and its specific needs.  Here are some of the training courses cGxP has developed for other clients:

    • New Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

    • lNew Guidance for Industry: Sterile Drug Products
      Produced by Aseptic Processing Current Good Manufacturing Practice.

    • lNew Guidance for Industry: Sterile Drug Products
      Produced by Aseptic Processing Current Good Manufacturing Practice.

      • New Guidance for Industry: Current Good Manufacturing Practice for Combination Products.

      • lISO 13485 and ISO 14979 Guidance for Medical Devices

      • Introduction to Design of Experiments

       

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    ·         Introduction to Statistical Process Control and Six Sigma

    ·         Introduction to Product and Process Risk Management and Analysis

    ·         Introduction to Statistics and Microsoft Excel

    ·         21'st Century Inspections: QSIT

    ·         Validation Master Planning

    ·         Process Characterization & Validation

    ·         Test Method Characterization & Validation

    ·         Cleaning Characterization/ Cleaning Validation

    ·         Equipment/ Instruments/ Utility/ Facility Qualification

    ·         Instrument/ Equipment Preventive Maintenance and Calibration

    ·         Non-Product Software Validation Procedure      (21 CFR Part 11)

    ·         Software Documentation for Equipment/ Instruments/ Facilities/ Utilities

    ·         Adverse Event Reporting and MDR Programs

    ·         CE/ ASQ/ ISO Worldwide Regulations

    ·         Complaints

    ·         Corrective and Preventive Action Systems- Exceptions, Deviations, and Nonconformances

    ·         Immunology for Non-Scientists

    ·         Immunology for Scientists

    ·         Pre-Approval Inspections

    ·         Readiness for Inspections

    ·         Sales/ Marketing/ and Field Service Training 

    ·         Statistical Analyses

    ·         Design Practices- Design Controls- cGDP

    ·         Clinical Practices- cGCP

    ·         Documentation Practices- cGDP

    ·         General Practices- cGGP

    ·         Laboratory Practices- cGLP

    ·         Manufacturing Practices- cGMP- CDER/CBER

    ·         Manufacturing Practices- cGMP/ QSR- CDRH

    ·         Policy Practices- GPP- Policies and Procedures

    ·         Quality Practices- cGQP

    ·         Regulatory Practices- cGRP

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     Please read our "Guidelines for Effective Training"  

 

 

 

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