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Course Spotlight: Good Manufacturing Practices Training

Apr 17, 2018

Whether you are someone who has worked in the CGMP field for years, or someone just getting started in this career, the Good Manufacturing Practices Training course is designed for you. This course can also be a great way for auditors, quality control managers, regulatory affairs professionals, and other production management career professionals to increase their knowledge in Good Manufacturing Practices (GMP). What is this course, and what can you expect to get from it?


Quick Description of the GMP Training Course


This is a three-day course that provides a thorough dive into the foundations of manufacturing and distribution regulations for the medical and pharmaceutical industries in the United States. The course covers topics such as:


  • Current Good Manufacturing Practices (CGMP)
  • A complete overview of the application of industry regulations per the FDA
  • Cost-effective production
  • Efficient problem resolution
  • How the FDA and U.S. GMPs impact EU regulatory procedures
  • Regulations pertaining to facilities and equipment
  • Vendor auditing
  • Validation
  • Recalls
  • Current emerging trends and hot topics in this field


Day one of the course takes you through the various regulations and regulatory agencies; day two includes information on facilities, vendors, process control, and much more; day three, a shorter day, wraps up with information about recalls, product releases, hands-on examples, discussion, and a Q&A session.


Basic Course Details


The course is held over three days. The first two run from 9:00 to 5:00, and the third runs from 9:00 to 3:00. Breakfast and lunch are included on all days.


The instructor for this course is careful to make the course interactive, engaging, and easy to understand. The presentations are designed for beginners, and questions are thoroughly addressed so that you leave with a thorough understanding of all the topics presented.


Is This Course Right for You?


This course is designed to be inclusive for many types of students. The course is perfect for the following:


  • A professional working in the CGMP field who wants to improve their ability to apply CGMP principles at work
     
  • Any person that is new to the CGMP or regulatory affairs career fields
     
  • Production and training managers who regularly need a basic understanding of CGMP principles 
     
  • Regulatory affairs professionals and auditors
     
  • Quality control managers
     
  • Anyone who wants to deepen their understanding of how to structure quality systems to manage regulatory compliance


What Can You Expect to Learn?


During this course, you will gain a thorough understanding of the industry requirements for U.S. medical and pharmaceutical regulatory practices, as determined by the FDA. In addition to that, you will also leave with an understanding of:


  • How to apply CGMP principles as a manager
  • How to design facilities and systems to ensure regulatory compliance
  • The key features and benefits of each major regulatory procedure
  • Modern GMP risk management tactics


Save On This Course When You Register Early


If you register for this course online at least 30 days before the course begins, you will receive an “early bird” discount. Learn more or apply online.


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