GMDP-0084
Senior GMP/GDP Auditor & Pharmaceutical Consultant
Op opdracht
Over deze 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.
Competenties
Expert
GDP Compliance
GDP (Good Distribution Practice)
GMP Auditing
Gevorderd
Regulatory inspection support
Sterile manufacturing
Radiopharmaceuticals
Controlled substances / narcotics
Highly potent / cytotoxic
API Manufacturing
Cleaning validation
Regulatory Submissions
Internal auditing
CAPA Management
Supplier Auditing
Gemiddeld
Biologics & biosimilars
Certificeringen
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)