Consultant, USA

Ralph Gomez, PhD

 Ralph Gomez, PhD

Ralph Gomez works as a freelance consultant in the area of Pharmaceutical Quality Management since 2007. In the years before he was working with Hoffmann-La Roche, where he started his career in 1966. He is a member of various expert committees, advisory panels and project teams.

During his career at Hoffmann-La Roche, he was Director of various departments within the Quality Management department and as such responsible for Roche clinical and marketed pharmaceutical products. His responsibility included methods development, stability testing, analytical problem solving, methods validation, process and cleaning validation support, routine analyses, dissolution testing, product complaint evaluations, laboratory metrology services, and technical writing in a GMP compliant environment.

He is author or co-author of the following chapters of GMP Compliance Adviser:

  • 8.C Cleaning validation master plan
  • 8.D Establishing the scope of validation
  • 15.A.3 Requirements of the US GMP Regulations
  • 15.C Batch documentation