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GMDP-0084

Senior GMP/GDP Auditor & Pharmaceutical Consultant

On Assignment
17
Years Experience
GMP & GDP
Specialization
Portugal
Location
About This Expert

Former regulatory GMP/GDP inspector with 17+ years in pharma. 385+ inspections/audits worldwide. Expertise in GMP/GDP compliance, inspection preparedness, CAPA, supplier qualification, and regulatory affairs.

Competencies

Expert
GDP Compliance GDP (Good Distribution Practice) GMP Auditing
Advanced
Regulatory inspection support Sterile manufacturing Radiopharmaceuticals Controlled substances / narcotics Highly potent / cytotoxic API Manufacturing Cleaning validation Regulatory Submissions Internal auditing CAPA Management Supplier Auditing
Intermediate
Biologics & biosimilars

Certifications

Pharma Science Global Conference GMP for biopharmaceutical manufacturing EU cGMP Annex 1, a practical approach Cleaning validation for multipurpose GMP facilities AI vs. GMP? Upcoming challenges 2020 Quality Risk Management Summit - Risk & Lifecycle Management of Pharma & Biopharma Operations 2019 Pharma Congress – Production & Technology Training on Good Distribution Practice – Portuguese delegate Environmental Monitoring EuPAT 5 – Fifth pan European GbH & PAT Science Conference, Continuous Innovation in Process Analytics & Control Theoretical and on-the-job training (initial and refresher training)
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