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Cristina Aparecida Diagone Fontana de Souza

CV Lattes ResearcherID ORCID

Universidade de São Paulo (USP). Instituto de Química de São Carlos (IQSC)  (Institutional affiliation from the last research proposal)
Birthplace: Brazil

Bachelor in Chemistry from the Institute of Chemistry (IQSC) of the University of São Paulo, master's and doctorate from IQSC in the areas of Physical Chemistry and Analytical Chemistry respectively. MBA in production engineering from UFSCAR. - Scientific initiation in Organic Chemistry at IQSC. - Experience in laboratory management and technical supervision of analytical laboratories in the areas of development and validation of methods and quality control, working in the following segments: pharmaceuticals (human and veterinary use), food, cosmetics, environmental, agricultural pesticides and herbal medicines. - Experience with analytical and instrumental techniques (Spectroscopic and Chromatography): Ultraviolet, Infrared, Nuclear Magnetic Resonance, High Performance Liquid Chromatography (HPLC) coupled to DAD detectors, Ion, MS (quadrupole), MSMS (triple quadrupole and Ion Trap), Gas Chromatography (GC) coupled to MS, FID, FPD and ECD detectors, ICP, Atomic Absorption, Karl Fischer, Titulometry, Colorimetry, Gravimetry, Solid Phase Extraction methods, Solid Phase Microextraction, Liquid-Liquid Extraction and other analytical techniques applied for each type of matrix (environmental, pharmaceuticals, cosmetics, pesticides, etc.). - Experience in analytical validations according to the type of matrix studied (examples): RDC 166/2017, ICH (guidelines), DOQ-GCRE-008 (INMETRO), Guidelines for the Validation of Analytical Methods used in Residue Depletion Studies PNCR: Guide for Validation of Analytical Methods and Internal Quality Control of Monitoring Analyzes of the National Plan for Residues and Contaminants - Animal PNCR. - Experience in studies of extractables and leachables in packaging, studies of photostability and stability (forced degradation) of cosmetics and drugs (human and veterinary use), pharmaceutical equivalence, bioequivalence, similarity between batches. - Technical responsible for the Accreditation, Control and Inspection Councils and Bodies (CRQ, Anvisa, MAPA, Inmetro). - Acting as Director of Studies and Manager of the Test Facility in accordance with the rules of GLP (Good Laboratory Practices) in the areas of pharmaceuticals and pesticides. 20 years of experience in the Quality Assurance area (ISO 17025 and GLP), working in the management and development of standard operating procedures, training, technical protocols, audit/inspection, scientific reports and implementation of new scopes (development of new areas for laboratories and companies). - Experience in regulatory affairs and studies for the development and registration of medicines and agrochemicals. - Experience in leading internal and external audits, actively participating, presenting projects, facilities and documents, answering questions and taking corrective and preventive actions. - External inspector GLP in laboratories and companies from 2014 to 2022. - Great people management skills, being responsible for teams of different backgrounds. - Knowledge of the main norms, resolutions and guides in force for the areas of pharmaceuticals, pesticides, cosmetics, veterinary and environmental. - Consultancy in audits (ISO 17025) and inspections (OECD/GLP) for laboratories and companies in the chemical field. Financial feasibility studies for the implementation and expansion of projects of different natures (cost reduction, productivity gains, process optimization, synergies and new services), business strategy and sales in the area of veterinary products, medicines and agricultural pesticides. Courses and training for professional qualification in the field of chemistry. Business director and founder of the Nature Lab Research and Analysis Laboratory Ltd from 2012 to 2016. (Source: Lattes Curriculum)

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