Services

GMP Training

ServicesGlobal ComplianceGMP Training

Even the enterprise has a very perfect GMP system, if the relevant personnel don’t understand the basic logic of GMP, the fundamental and procedures, it will be difficult to ensure the routine operation of GMP, and will increase heavily the risk of audit and inspection failures. This is one of the reasons that GMP regulations require companies to ensure adequate trainings for the relevant personnel.

gempex focus on providing customized training courses according to the customers’ actual situation. Our GMP trainers are all with many years of working background in pharmaceutical quality relevant departments as well as rich project execution experience. In the course, the experts will elaborate the requirements of GMP regulations in details, at the same time will integrate their practical experience into the training topics and guide the trainees to discuss in the class or in groups. Finally, gempex will summary the key elements which can be implemented in the daily work. Therefore, trainees can truly understand the philosophy behind the requirements of GMP regulations.

Service Advantage

Surveying the training needs and customizing training courses

Making complexity comprehensible and easily to understand

Combining the systematic GMP regulatory with the practical skills

advantage

Training Approach

Classroom training

A combination of lectures by consultants and classroom exercises


Workshops

Target specific issues or research specific topics

Training Topics

GMP Compliance & IT compliance Training Topic

  • GMP Basic Regulation
  • Inspection Preparation
  • Interpretation of Regulations and Guidelines
  • Audit Training
  • Risk Assessment / Risk Management
  • IT Compliance
  • Data Integrity Training

Qualification & Validation Topic

  • Validation Regulations and Management
  • Cleaning Validation
  • Continuous Process Validation
  • Analytical Methods Validation
  • IT Validation
  • Sterilization Process Practice
  • Plant Facilities and Equipment Qualification Practice
  • GEP & GMP Efficient Integration Strategy

GMP System Training Topic

  • Good Document Management Practices
  • Organizational Planning and System Structure
  • Drug Life Cycle
  • GMP Guideline
  • Supplier Management
  • Quality Elements such as Change and Deviations

Other Appointed Training Topic

  • New Set-up Facility Typical Pitfalls and Measures
  • Aseptic Process Assurance
  • MAH Regulations
  • Other Customized Training Topics

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