Nicolas Bidaud Email & Phone Number

Brisbane City, Qld, Au

Brisbane, Queensland, Australia

Brisbane, Queensland, Australia

• Facilitation of root cause analysis sessions• Work groups coordination to ensure corrective actions are implemented • Deviation reports authoring, review, and approval (Trackwise)• Deviation reports follow up to ensure that appropriate preventative actions are implemented• Follow up and monitoring to ensure that effective control measures are in place to prevent deviation recurrence

Brisbane, Queensland, Australia

• Complaint intake, sorting, ranking and investigation• Complaint management system tendering and commissioning • Complaint investigation coordination. Different stakeholders (IT, Electronic, Biological, Contract Packer…)• FDA reporting process set up and maintenance• Customer service engagement (outsourced customer help line)

Brisbane, Australia

• Management of adverse event reporting and complaints for Cook Medical products• Electronically process events to determine complaint and reportability status• Complete electronic submission of applicable Medical Device Reports (MDRs) to the TGA, EU and FDA as required per internal policy & procedures and regulations• Ensure complaint investigations are adequate, accurate, detailed and timely• Collaborate with appropriate technical, clinical, field/sales and/or returned product… Show more • Management of adverse event reporting and complaints for Cook Medical products• Electronically process events to determine complaint and reportability status• Complete electronic submission of applicable Medical Device Reports (MDRs) to the TGA, EU and FDA as required per internal policy & procedures and regulations• Ensure complaint investigations are adequate, accurate, detailed and timely• Collaborate with appropriate technical, clinical, field/sales and/or returned product analysis employees to determine reporting eligibility• Generate responses to inquiries on adverse event reports from various global regulatory authorities• Work closely with global Cook Medical vigilance team• Maintain a working knowledge of regulations and standards related to post-market quality & complaint handling Show less

Brisbane, Australia

• Commissioning of a new manufacturing softgel capsule line• Selection and auditing of softgel equipment suppliers• Coordination of softgel validation activities (equipment, premises, process)• Involvement in TGA audit process (new dosage form manufacturing license) • Re-qualification of production environment monitoring system• Commissioning of a new stability chamber• Follow up of production environment condition out of specifications

Auckland, New Zealand

• IQOQPQ protocols drafting, execution and review for manufacturing, packing and laboratory equipment• Coordination of the different qualification stakeholders• Involvement in the DQ, FAT and SAT process• Process validation protocols execution and review for solid, oral liquid and softgel capsule• General utilities qualification (purified water, vacuum, compressed air…)• High potent manufacturing suite commissioning and qualification• Involvement in the change control… Show more • IQOQPQ protocols drafting, execution and review for manufacturing, packing and laboratory equipment• Coordination of the different qualification stakeholders• Involvement in the DQ, FAT and SAT process• Process validation protocols execution and review for solid, oral liquid and softgel capsule• General utilities qualification (purified water, vacuum, compressed air…)• High potent manufacturing suite commissioning and qualification• Involvement in the change control process • Involvement in Product Quality Reviews Show less

Lyon Area, France

Engagement with subcontractors• International suppliers (Australia, Ireland, Spain, Switzerland...)• Technical support (assistance for new product introduction)• Formulation, process improvement and streamlining • Follow up of the stability studies• Follow up of the manufacturing, packaging schedules and lead timesCoordination of product launches• Support to quality, regulatory and supply chain departments• Pilot batch and scale up assessment• Master… Show more Engagement with subcontractors• International suppliers (Australia, Ireland, Spain, Switzerland...)• Technical support (assistance for new product introduction)• Formulation, process improvement and streamlining • Follow up of the stability studies• Follow up of the manufacturing, packaging schedules and lead timesCoordination of product launches• Support to quality, regulatory and supply chain departments• Pilot batch and scale up assessment• Master documentation (validation and batch record) review and approbation • Manufacturer / site product transfers • Coordination of the first product launch under Mylan brand in France Show less

Melbourne, Australia

Antigens purification• Antigens purification on sucrose gradient• In process and environmental controls• Handling under safety cabinetAntigens filtration and concentration• Automated plant handling• Reagents and buffers dispensing

Melbourne, Australia

Pellets coating in fluid bed dryer• Enteric coating on acid sensitive API• Excipients selection (contacts and negotiations with suppliers)• Formulation and feasibility studies• Assessment of the dissolution profile• Follow up of the stability studies• Critical parameters identification and process validationEncapsulation of several formulations • Direct encapsulation formulation• Assessment and improvement of the product flowlability• Process… Show more Pellets coating in fluid bed dryer• Enteric coating on acid sensitive API• Excipients selection (contacts and negotiations with suppliers)• Formulation and feasibility studies• Assessment of the dissolution profile• Follow up of the stability studies• Critical parameters identification and process validationEncapsulation of several formulations • Direct encapsulation formulation• Assessment and improvement of the product flowlability• Process validationParticipation in the setting up of a new plant• Facility qualification assistance• Standard operating procedures drafting Show less

Lyon Area, France

Operation of a new microfluidization zone (API micronisation)• Participation in batch validation• Automated facility• Work on ongoing process improvementTwo and three layers tablets compression• In process control: friability, hardness, weight uniformity, diameter, thickness• Installation of a tablet metal detector Granulation in fluid bed (microfluidized suspension spraying on lactose support)• Participation in batch validation• Granules milling Show more Operation of a new microfluidization zone (API micronisation)• Participation in batch validation• Automated facility• Work on ongoing process improvementTwo and three layers tablets compression• In process control: friability, hardness, weight uniformity, diameter, thickness• Installation of a tablet metal detector Granulation in fluid bed (microfluidized suspension spraying on lactose support)• Participation in batch validation• Granules milling Show less

Lyon Area, France

Laboratory development of a liquid form process (parenteral emulsion)• Microencapsulation of an irritating API • Compatibility study API / excipients• Emulsion characterisationParticipation in spray cooling process development • Cytoxic API Incorporation in a lipidic matrix • Powder characterisation • Compression trials (formulation study)• Tablet controls (dissolution, hardness, friability, stability)

Lyon Area, France

Reformatting dossier in CTD format• Module 3 (drug product section) of dossier • Harmonisation between European, Japanese and American presentation Post approval modifications• Submission of change applications / notifications to European and French regulatory agency• Change type determination• Process changes (equipment, critical parameters)• Batch size (scale up or scale down)• Manufacturer, API sourcing changes Technical link with contract… Show more Reformatting dossier in CTD format• Module 3 (drug product section) of dossier • Harmonisation between European, Japanese and American presentation Post approval modifications• Submission of change applications / notifications to European and French regulatory agency• Change type determination• Process changes (equipment, critical parameters)• Batch size (scale up or scale down)• Manufacturer, API sourcing changes Technical link with contract manufacturers• Validation report review• Master document assessment Show less

Lyon Area, France

Pan coater installation and qualification • Installation Qualification, Operational Qualification, Performance Qualification• Manufacturing and cleaning procedures drafting Wet granulation in mixer-granulator-dryer• Equipment fitted with micro waves dryer system and video camera• In process control: Residual humidity, flowlability, apparent volumeTableting on single station and rotative press• Technical and clinical batches manufacturing• Tablet controls… Show more Pan coater installation and qualification • Installation Qualification, Operational Qualification, Performance Qualification• Manufacturing and cleaning procedures drafting Wet granulation in mixer-granulator-dryer• Equipment fitted with micro waves dryer system and video camera• In process control: Residual humidity, flowlability, apparent volumeTableting on single station and rotative press• Technical and clinical batches manufacturing• Tablet controls (desegregation, hardness, friability, weight, diameter, thickness) Show less

Lyon Area, France

• Class 100 in a class 1000 environment• Intermediate product sterile repartition• Ongoing training for sterile handling• In process controls: Particule controls (laser counter), Microbiological controls (agar plate, aerobiocollector) Antigens coupling• Chemical coupling in refrigerated tank• Critical parameters check (agitation speed, pH, temperature, adding components time-limit) Antigens purification • Purification on sucrose gradient… Show more • Class 100 in a class 1000 environment• Intermediate product sterile repartition• Ongoing training for sterile handling• In process controls: Particule controls (laser counter), Microbiological controls (agar plate, aerobiocollector) Antigens coupling• Chemical coupling in refrigerated tank• Critical parameters check (agitation speed, pH, temperature, adding components time-limit) Antigens purification • Purification on sucrose gradient (ultracentrifugation)• Harvest of the most active fraction using refraction method (refractometer)• Equipment cleaning (formaldehyde solution) Sterile filtration • Disc filter holder (filtration by pressure) Show less

Lyon Area, France

Wet granulation in mixer-granulator-dryer• Routine production of several formulations• Participate in new product granulation scale up• CIP system handling Liquids form process (syrups and drinking suspension)• Operating on three syrup lines (5000, 10 000 and 15 000L)• Filtration through plaque filters or cartridges • Standard operating procedures drafting• Equipment qualification (stirrers, pumps, thermometers…)Reverse osmosis water station… Show more Wet granulation in mixer-granulator-dryer• Routine production of several formulations• Participate in new product granulation scale up• CIP system handling Liquids form process (syrups and drinking suspension)• Operating on three syrup lines (5000, 10 000 and 15 000L)• Filtration through plaque filters or cartridges • Standard operating procedures drafting• Equipment qualification (stirrers, pumps, thermometers…)Reverse osmosis water station supervision • Replacement of pre-filter and active charcoal filter • Loop components checks (circulation pump, temperature exchanger, automated valves,resistivity and conductivity probes) Show less

Master, Design And Development Of Product For The Pharmaceutical Industry

Bachelor, Engineering And Quality Of Pharmaceutical Industries

Bachelor, Advanced Diploma Of Science (Pharmaceutical Industry Technician)

Education record