Barbara L. N. S. Do Rego
Winter Garden
Summary
Dynamic professional with an unwavering passion for science, extensive experience in regulatory compliance and quality assurance. Proven track record in product registration and process validation, complemented by solid problem-solving skills. Successful implementation of Good Manufacturing and Control Practices, improving operational efficiency and ensuring compliance with health standards.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Technical Director and Legal Representative
Newsteri do Brasil Comércio, Importação e Exportação Ltda.
PORTO ALEGRE
05.2014 - Current
- Product Registration with ANVISA
- Implementation of Good Manufacturing and Control Practices
- Company Regularization
- Technical Customer Service
- Training in Product and Equipment Validation
- Sale of Medical-Hospital Products specialized in Sterilization
Partner and Technical Consultant
Silveira & Rego Com. de Prod. Hosp. e de Laboratório Ltda. - Pharmaq Consultoria Especializada
PORTO ALEGRE
01.2013 - Current
- Technical Consulting Company in the area of environment and medical-hospital products
- Product Registration at ANVISA
- Internal Audit Certification in Good Manufacturing and Control Practices
- Implementation of Good Manufacturing and Control Practices
- Regularization of companies in the health sector
- Technical Responsible for the Transportation of Hazardous Cargoes with regulatory agencies
- Qualification of Sterilization Autoclaves (steam, ethylene oxide and plasma)
- Validation of Sterilization Process
- Preparation and Execution of Project to reduce ethylene oxide gas emissions into the atmosphere
Quality Manager and Technical Manager
IODONTOSUL - Souza & Leonardi Ltda.
PORTO ALEGRE
11.2012 - 06.2013
- Company Overview: Dental Products Industry with national operations
- Responsible for inspections for Certification of Good Manufacturing Practices
- Quality Manager responsible for implementing Good Manufacturing Practices
- Training of employees in matters related to Quality Control, Production and Good Manufacturing Practices
- Management of Chemical Products Controlled by the Army and Federal Police
- Coordination of the production sector and quality control
- Dental Products Industry with national operations
Quality Manager and Technical Manager
INODON LABORATÓRIO IND. DE PRODUTOS ODONTOLÓGICOS LTDA.
PORTO ALEGRE
03.2005 - 11.2012
- Company Overview: Dental Products Industry with national operations
- Responsible for the company's production planning and control
- Responsible for qualifying product and service suppliers
- Preparation of biannual production indicators
- Coordination of the production sector team
- Responsible for preparing documentation of Good Manufacturing and Control Practices
- Preparation of technical reports for product registration with ANVISA
- Preparation of technical dossier for Product Registration with ANVISA and subsequent Certification in Good Manufacturing and Control Practices
- Dental Products Industry with national operations
Education
Specialization in Material and Sterilization Center Management -
CCIH - Hospital Infection Control Competence Cours
São Paulo01.2021
Specialization in Regulatory Affairs in the Pharmaceutical Market -
ICTQ - Institute of Science And Quality Technology
Goiânia01.2014
Degree in Industrial Chemistry -
UFRGS - Federal University of Rio Grande Do Sul
Porto Alegre01.2003
Skills
- Legal and regulatory compliance
- Product registration
- Quality assurance
- Process validation
- Technical training
- Auditing processes
- Problem-solving abilities
Certification
- Degree in Industrial Chemistry, UFRGS, 2003
- Specialization in Regulatory Affairs in the Pharmaceutical Market, ICTQ, 2014
- Specialization in Material and Sterilization Center Management - CME, CCHI, 2021
- Professional Registration and Authorization in Industrial Chemistry, Regional Chemistry Council, 5th Region
Publications
Scanning electron microscopy analysis of third-generation PMMA: a comparative experimental study, 2022
Extracurricular Activities
Member of the Regional Chemistry Council of the 5th Region (CRQ-V), 2003 Speaker at the National Oral Health Week of the Municipality of Campo Largo/PR, 2019
Languages
- Portuguese, First Language
- English, Upper Intermediate (B2)
- Spanish, Elementary (A2)
Courses And Conferences
- Transportation of Dangerous Goods Update, IAPC and CRQ V, Porto Alegre, 04/01/15
- Transportation of Dangerous Goods, IAPC and CRQ V, Porto Alegre, 08/01/13
- Internal Auditor Training ISO 9001 - ISSO 13485 - RDC 16/2013, SINDIFAR, Porto Alegre, 06/01/13
- How to Create and How to Audit a Quality Management System ISO 9001 - ISSO 13485 - RDC 16/2013, SINDIFAR, Porto Alegre, 05/01/13
- Periodic Review of Quality System Documents, SINDIFAR, Porto Alegre, 04/01/13
- Training in Good Manufacturing Practices for Medical Products - Documentation and Implementation, GMP Consultoria, São Paulo, 02/01/07
- Course on Good Manufacturing and Control Practices - Interpretation of the Standard - RDC 59, INBRAVISA, Porto Alegre, 09/01/06
- Internal Auditor Course - ISO 9001, Konrad Consultoria, Porto Alegre, 01/01/03
- Environmental Management Course - ISO 14001 - Implementation and Auditing, Liberato Salzano Technical School Foundation, Novo Hamburgo, 07/01/01
- Treatment of Industrial Solid Waste, Liberato Salzano Technical School Foundation, Novo Hamburgo, 05/01/01
Timeline
Technical Director and Legal Representative
Newsteri do Brasil Comércio, Importação e Exportação Ltda.
05.2014 - Current
Partner and Technical Consultant
Silveira & Rego Com. de Prod. Hosp. e de Laboratório Ltda. - Pharmaq Consultoria Especializada
01.2013 - Current
Quality Manager and Technical Manager
IODONTOSUL - Souza & Leonardi Ltda.
11.2012 - 06.2013
Quality Manager and Technical Manager
INODON LABORATÓRIO IND. DE PRODUTOS ODONTOLÓGICOS LTDA.
03.2005 - 11.2012
Specialization in Material and Sterilization Center Management -
CCIH - Hospital Infection Control Competence Cours
Specialization in Regulatory Affairs in the Pharmaceutical Market -
ICTQ - Institute of Science And Quality Technology
Degree in Industrial Chemistry -
UFRGS - Federal University of Rio Grande Do Sul
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