The requirements for the quality and purity of Active Pharmaceutical Ingredients have increased enormously, among others, due to the establishment of the ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”. Therefore, highly qualified experts are necessary to put these requirements correctly into practice. The ECA Certified API Production Manager learns the rudiments in one of the intensive courses and can deepen this know-how according to his or her focus by means of two further seminars.
ECA Certified
API Production Manager
Courses and Conferences acknowledged
To obtain the additional certificate, the applicant must attend three out of the following courses/conferences. After attending the third course, the applicant obtains the additional certificate “ECA Certified API Production Manager”.
- ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis
- ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation
- ICH Q7 Auditor Training Course
- APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
- Handling of Foreign Particles in APIs and Excipients
List of all courses and conferences currently offered and acknowledged in this programme
(including detailed information on every event – venue, dates, fees and agenda as PDF)
(including detailed information on every event – venue, dates, fees and agenda as PDF)
Your Questions
For questions relative to the ECA Certified API Production Manager, please contact enquiry@gmp-compliance.org.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others