• Name
    Good Manufacturing Practice (Twelve modules) - Price $477
  • Details
  • Outline

    Introduction:

    The twelve modules contained in this course are a comprehensive course in the fundamentals of Good Manufacturing Practice, GMP. GMP is a federal regulation developed and enforced by the United States Food and Drug Administration (FDA) to ensure that pharmaceutical and medical device products safe, pure, and effective. All pharmaceutical and medical device manufacturers within the United States or who intend to market their products within the United States are required to comply with GMPs. All employees of these companies are required by the GMP regulation to be trained in GMP. This course can help you meet this requirement.

     

    Course Description:

    Each module is designed to take from ten to twenty minutes to complete. Each module contains a test comprised of ten questions. Your test score will be saved. When you complete a module and test successfully, you can print a certificate of completion.

     

    Objectives:
    Upon completion of this workshop, participants will be able to:

    1.      Understand FDA and  GMP terms they are likely to encounter.

    2.      Understand the intent of the GMP regulations.

    3.      Have a thorough understanding of the breadth and scope of the GMP regulations.

    4.      Develop a personal commitment to comply with the GMP regulations.

    5.      Recognize violations and potential violations of the GMP regulations.

     

    Module One – History of GMP                                          

    ·        The evolution of Food and Drug laws and regulations

    ·        Key milestones in FDA law

     

    Module Two – Our Customers Trust Us                            

    ·        Our customers are called patients

    ·        The notion of trust

    ·        The role of the FDA

    ·        Determining the cost of failure

    ·        The consequences of failure

    ·        The role of consistency

    ·        The aim to have happy customers

     

     Module Three – Writing Good Procedures                       

    ·        Written procedures – a fundamental of Good Manufacturing Practice

    ·        Identifying a well-written procedure

    ·        Requirements for writing effective procedures

    ·        Requirements for controlled documents

     

    Module Four – Keeping Good Records, Part One              

    ·        Good record keeping – a fundamental of Good Manufacturing Practice

    ·        Why so much paperwork is required

    ·        The importance of keeping accurate records

    ·        The first four record keeping requirements

     

    Module Five – Keeping Good Records, Part Two                

    ·        Good record keeping – a fundamental of Good Manufacturing Practice

    ·        Why so much paperwork is required

    ·        The importance of keeping accurate records

    ·        The final six record keeping requirements

     

    Module Six– Following Our Procedures                           

    ·        Following procedures – a fundamental of Good Manufacturing Practice

    ·        The importance of written procedures in producing consistently high quality products

    ·        What to do when you can’t follow the written procedure

    ·        Reasons why written procedures are sometimes not followed

    ·        Consequences of not following written procedures

    Module Seven – Managing Our Materials                          

    ·        Materials management – a fundamental of Good Manufacturing Practice

    ·        Definition of materials

    ·        The importance of a quarantine area for unreleased materials

    ·        Sampling, testing, and release of materials for use

    ·        Raw materials, work-in-process, and finished goods materials

    ·        Final product testing and release

    ·        Accurate record keeping

    Module Eight– Checking and Double Checking                  

    ·        Checking a double checking – a fundamental of Good Manufacturing Practice

    ·        Striving for accuracy in approaching work

    ·        Utilizing a line clearance procedure

     

    Module Nine – Guarding Against Contamination 

    ·        Keeping things clean – a fundamental of Good Manufacturing Practice

    ·        Definition of contamination

    ·        Sources of contamination

    ·        Types of contamination

    ·        Cross-contamination

    ·        What to do when you see potential contamination

     

    Module Ten – Maintaining Our Buildings and Equipment         

    ·        Building and equipment maintenance – a fundamental of Good Manufacturing Practice

    ·        Why maintenance is so important

    ·        GMP requirements for building and equipment maintenance

    ·        Calibration of equipment requirements

    ·        What to do when observing any condition which could lead to contamination, mix-ups, or errors

     

    Module Eleven – Performing Self-Audits                            

    ·        Audits – a fundamental of Good Manufacturing Practice

    ·        Why we perform audits

    ·        Six areas to check when conducting an audit

    ·        The benefit of conducting audits

     

    Module Twelve – People, The Key to Success                        

    ·        Customer trust – a fundamental of Good Manufacturing Practice

    ·        Our competence is our customers’ expectation

    ·        GMP requirements for training, education, and experience

    ·        The consequences of failure

  • Duration
  • Fee =N= 0.00
  • Inplant NO
  • Classroom NO
  • Online YES



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Good Manufacturing Practice (Twelve modules) - Price $477

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