Global Head Qualification & Validation
Jo Doucet is an expert in qualification and validation with over 20 years of experience in the pharmaceutical industry. He leads the Qualification/Validation division at QbD Group, supporting teams and clients in GxP compliance projects across manufacturing, IT, QC, and medical devices.
Utilities such as pharmaceutical water systems and gases are often overlooked in Annex 1 remediation. Discover common compliance gaps and how to mitigate them.
阅读更多
What do 230 FDA warning letters reveal about recurring sterile manufacturing deficiencies? This white paper analyses inspection findings from 2023–2025 and maps them to EU GMP Annex 1 expectations, revealing where manufacturers most frequently fall short of sustainable compliance.
阅读更多
The Annex 15 revision will make qualification and validation mandatory for API manufacturers. Learn how to prepare lifecycle validation and inspection readiness.
阅读更多
Learn how Annex 1 expectations for cleanrooms, isolators and RABS shape modern aseptic manufacturing. Practical guidance on barrier strategy, airflow visualization and contamination control.
阅读更多
How a practical Contamination Control Strategy and aseptic process design help manufacturers meet EU GMP Annex 1 expectations in real operations.
阅读更多
Learn the key requirements for validating Single-Use Systems, with guidance on supplier control, compliance, and Extractables & Leachables risk management.
阅读更多