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Automating Document, Trial and Quality Management: Software Application for Healthtech
March 10, 2022 @ 9:00 am - 10:30 am AEDT
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In addition to Good Manufacturing Practice (GMP) compliance, it is recommended that an effective quality management system is adopted by any Healthtech organisation that intends to commercialise a product. Quality management provides continuous improvement, enhancing patient health outcomes and business success.
Control in document, trial and quality management can make or break a research project, clinical trial or product development pipeline.
BioMelbourne Network, in collaboration with SeerPharma and market-leading software provider MasterControl, brings you this event, which aims to alleviate these issues. Over the last five years, more than 50 organisations in our sector have turned to SeerPharma and MasterControl to help automate their document, trial and quality management activities.
Register below to learn how you too can gain greater control over your product development!
Event details
Date: Thursday 10 March 2022
Time (AEDT): 9:00am – 10:30am
Format: Online via Zoom Webinar
Registration: Free to attend for Members and Non Members
Guest speakers (read bios below):
Patricia Santos-Serrao, RAC, Director of Clinical and Regulatory Product Strategy, MasterControl
Luana Carone, Solutions Consultant, APAC, MasterControl
Daniel Flewellen, Senior Consultant / Contracting Services Manager, SeerPharma
Host and Facilitator:
Jeff Malone, CEO, BioMelbourne Network
This BioMelbourne Network event is delivered in partnership with SeerPharma and MasterControl
Patricia Santos-Serrao, RAC, Director of Clinical and Regulatory Product Strategy, MasterControl
Patricia Santos-Serrao started her career in the life sciences industry in 1994 at Schering-Plough in Kenilworth, NJ and later joined Boehringer Ingelheim Pharmaceutical in Ridgefield, CT. She took a leading role within both organizations in transitioning business processes, document management, and submission compilation from a paper to electronic system.
She is a member of Regulatory Affairs Professional Society (RAPS) and has earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is a member of the Drug Information Association (DIA) and the DIA-sponsored TMF Reference Model Working Group.
She is a member of Regulatory Affairs Professional Society (RAPS) and has earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is a member of the Drug Information Association (DIA) and the DIA-sponsored TMF Reference Model Working Group.
Luana Carone, Solutions Consultant, APAC, MasterControl
Luana Carone is the Solutions Consultant for APAC at MasterControl’s Melbourne, Australia office. She has more than 17 years’ experience in the life sciences sector in a variety of roles, and prior to joining MasterControl, she worked for Australia Red Cross Blood Service, CSL Bioplasma, SAFC Biosciences and Medmont International.
Luana has also served as a consultant for Seerpharma, MIA and Integrated Consulting Solutions. She holds a Bachelor’s Degree in Biological Science, and a Diploma in Quality Auditing.
Luana has also served as a consultant for Seerpharma, MIA and Integrated Consulting Solutions. She holds a Bachelor’s Degree in Biological Science, and a Diploma in Quality Auditing.
Daniel Flewellen, Senior Consultant / Contracting Services Manager, SeerPharma
Daniel has 20 years broad pharmaceutical experience across various technological areas (scientific and IT) as a validation and IT compliance specialist. He has experience conducting IT, CSV and DI gap analysis and compliance audits for companies on quality systems and CSV programs. Daniel trains in computer validation (21 CFR Part 11, Annex 11, Data Integrity and GAMP) and assists companies establish IT compliance and computer validation programs.
He regularly gets involved with specific validation projects in clinical, manufacturing and laboratory environments and has expertise in ISO 13485, IEC 62304 and CFR 820 regulations.
He regularly gets involved with specific validation projects in clinical, manufacturing and laboratory environments and has expertise in ISO 13485, IEC 62304 and CFR 820 regulations.
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