The pharmaceutical industry is one of the most tightly regulated markets globally. A product can only be marketed once all requirements are met. During the cGxP Pharmaceutical Good Practices course, you will delve into the cornerstones of pharmaceutical quality systems and key aspects of legislation.
- Gain insights into guidelines, regulations, and directives for European, American, and other markets
- Understand the different phases in the lifecycle of a drug: from development to commercial production
- Learn to correctly interpret legislation and implement it in practice
About the training cGxP - Pharmaceutical Good Practices
The legislation governing the pharmaceutical industry comprises a complex array of guidances, standards, directives, and regulations that can vary significantly between countries. Terms like GxP and GMP are frequently used, but what do they actually mean? What specific laws and requirements do they entail? The cGxP - Pharmaceutical Good Practices training provides an overview of various legislative and advisory bodies and helps you correctly interpret laws and regulations.
Program
During the cGxP - Pharmaceutical Good Practices training, the following topics will be covered:
- History of legislation
- Legislative bodies, international organizations
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Clinical Practices (GCP)
- Good Distribution Practices (GDP)
- Good Documentation Practices (GDP)
- Pharmaceutical quality systems
- Risk management
- Validation
- Change Control, CAPA, calibration
- Personnel and training
- Audits and self-inspection
- Infrastructure and equipment
- Current trends, including verification and GAMP5
This training provides clarity on pharmaceutical quality systems and key aspects of legislation.
Contact us for more inforomation
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Our training manager is happy to think along with you!
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.