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Basics of GMP for Pharmaceutical Industry

Course Details

This course is designed to help participants understand the GMP as it relates to the pharmaceutical industry. 

Participants will gather information about the European regulator, how it enforces GMP requirements, and what to expect during a routine GMP inspection. 

Participants will investigate the science behind the requirements, the challenge of defending products against contamination, how to consistently build quality into products, and how to personally audit for GMP compliance and performance. The course will conclude with a discussion on the basic GMP requirements related to facility and equipment controls.

 

We will ensure this event is enjoyable and educational.

$300.00

Description

Course Details

This course is designed to help participants understand the GMP as it relates to the pharmaceutical industry. 

Participants will gather information about the European regulator, how it enforces GMP requirements, and what to expect during a routine GMP inspection. 

Participants will investigate the science behind the requirements, the challenge of defending products against contamination, how to consistently build quality into products, and how to personally audit for GMP compliance and performance. The course will conclude with a discussion on the basic GMP requirements related to facility and equipment controls.

 

We will ensure this event is enjoyable and educational.

What you will learn

  • History of the GMP regulations, the regulatory process, when does it all begin and why
  • Explore GMP principles and quality tools for managing the quality of the the whole drug manufacturing process
  • Learn easy-to-grasp basics of current issues, and trends in the pharmaceutical industry with an emphasis on applying GMP in day-to-day operations

Who Should Attend

  • Quality assurance, quality control, regulatory affairs, validation, manufacturing, and engineering professionals who need a fundamental understanding of the GMPs related to pharmaceutical operations
  • Students and young specialists who study at pharmaceutical, (bio)chemical, biological and relevant sphere and want to become quality experts in the future workplace
  • Service organizations, suppliers, and vendors who serve pharmaceutical industry clients

Agenda

Day 1

16:30 - 18:30
GMT+4

Registration
Greetings
Introduction to GMP
Day 2

16:30 - 18:30
GMT+4

Personnel
Facility & Equipment: Production
Day 3

16:30 - 18:30
GMT+4

Quality Control: Documentation Management

Day 4


16:30 - 18:30
GMT+4

External Activities
Complaints & Product Recalls
Day 5


16:30 - 18:30
GMT+4

Self Inspection

 

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