ECA Certified Pharmaceutical Engineer
In pharmaceutical and API production, essential prerequisites for manufacturing in conformity with GMP. Here, it is important to combine technical know-how with the interpretation of pharmaceutical regulations and guidelines.
On the other hand, the understanding of the process is very important to define risks for the product, to carry out a qualification/validation and to ensure a safe product. The Technical Operations Manager has the necessary skills for this task.
Courses and Conferences acknowledged
To receive the certificate, the applicant must attend three out of the following courses/conferences. After attending the third course, the applicant obtains the certificate “ECA Certified Pharmaceutical Engineer”. One exception is the course “Pharma-Engineering & Technical Systems”, which consists of two three-day parts. By attending both Part I and Part II you will also receive the certificate.
- Clean Rooms & HVAC Systems – GMP requirements for planning, qualification & operation
- Continuous Manufacturing of Oral Solid Dosage Forms
- Pharma-Engineering & Technical Systems*
Part I - GMPs for Equipment, Utilities and Facilities
Part II - Qualification and Manufacturing Technology - Pharmaceutical Water – Generation, Monitoring & Compliance
- Granulation & Tabletting – Process, Scale-Up, Trouble Shooting
- Lyophilization – Includes Workshop at GEA
- Container-/Closure Integrity Testing
- Visual Inspection Systems for Parenterals
- Renovation and Upgrading of GMP Facilities
- Single-Use Systems for Sterile & Biotech Applications
- Product Transfer – Organisation of a GMP-compliant Site Change
* Attending both parts is sufficient to complete the certification.
Your Questions
For questions relative to the ECA Certified Pharmaceutical Engineer, please contact enquiry@gmp-compliance.org.