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Environmental Monitoring: Pharmaceutical Clean Rooms

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.

$120.00

Description

Course Details

Environmental monitoring plays a key role in the pharmaceutical and cosmetics industries (significantly in aseptic or parenteral production), to ensure the safety during the manufacturing of health care products.

 

The course provides an in-depth review of technical and regulatory information on monitoring the air, surface and personnel in cleanrooms, isolators and RABS used in the pharmaceutical industry.

Participants will gather information about the regulatory requirements of environmental monitoring of cleanrooms, its validation, qualification and control. The course is based on the most recent editions of GMP and USP guidelines and provides information about cleanroom classification according to the ISO standards.

 

The personnel who will be trained on this course will be able to minimize the risks and to maintain the required production quality. 

 

We will ensure this event is enjoyable and educational.

What you will learn

  • The clean rooms classification, validation and control
  • The importance of a good environmental monitoring program 
  • How to identify the potential routes of contamination
  • The testing and control of the clean rooms environment 

Who Should Attend

  • Quality assurance, quality control, environmental monitoring, validation, manufacturing, and engineering professionals who need a fundamental understanding of the pharmaceutical clean rooms and environmental monitoring
  • 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

17:00 - 18:30
GMT+4
Registration
Greetings
Pharmaceutical Clean Rooms
Day 217:00 - 18:30
GMT+4
Environmental Monitoring: Methods

 

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