ECA Certified Technical Operations Manager

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 Technical Operations Manager”.

  • Clean Rooms & HVAC Systems – GMP requirements for planning, qualification & operation
  • Continuous Manufacturing of Oral Solid Dosage Forms
  • GMPs for Equipment, Utilities and Facilities
  • 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

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