GMP Training

Even if an enterprise has a robust GMP system, if the relevant personnel don’t understand the basic logic of GMP, fundamentals and procedures, it will be difficult to ensure the routine operation of GMP, and will significantly increases the risk of audit and inspection failures. This is one of the reasons that GMP regulations require companies to ensure adequate training for the relevant personnel.

gempex specializes in providing customized training courses according to the customers’ actual situation. Our GMP trainers are all with many years of professional experience in pharmaceutical quality relevant departments as well as rich project execution experience. In the course, the experts will detail GMP regulatory requirements, 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 core philosophy behind GMP regulatory requirements.

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

Services