Injectables Technologists, Process Scientists, Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, QC & QA Managers
This two-day interactive course is providing vital practical insights into QbD implemented Process Scale-up, Technology Transfer and Process Validation for Sterile Injectable Dosage Forms.
CEO
Protea
Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and overthe-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as independent ICH-GCO and GLP auditor in clinical trials.
CEO
Protea
Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and overthe-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as independent ICH-GCO and GLP auditor in clinical trials.
For the detailed agenda with a full breakdown of the individual sessions fill out this form.
