PDA Brazil Chapter Webinar: Data Integrity & Data Privacy - TR 80

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WORKSHOP INTEGRIDADE DE DADOS - ONLINE

Você está convidado a participar do webinar informativo interativo do capítulo PDA Brasil sobre Maio 25-29, en São Paulo

Horário - 14:00 - 17:00

Maio 25 – Introdução - 4 horas

  1. Conceitos e vocabulário
  2. ID em Sistemas Manuais e Computadorizados
  3. Fatores humanos
  4. ID conforme PICS e agências regulatórias
  5. Desvios e problemas mas frequentes
  6. Gerenciamento de riscos
  7. Auditoria para Integridade de Dados

Maio 26-29  - 3 horas

  1. Metodologia para implementar Integridade de Dados
  2. Mapeamento de Dados e seus fluxos
  3. PDA TR80 – Guia de Integridade de Dados para Laboratório
  4. Controle de acesso e assinatura eletrônica
  5. Trilha de Auditoria
  6. Integridade de dados para Manufatura
  7. Nova guia de Anvisa sobre Validação de Sistemas VSC
  8. Boas praticas de documentação e fluxogramas de processos
  9. Paperless e Automação
  10. Qualificação de fornecedores de tecnologia
  11. Lei de privacidade e proteção brasileira


Event Flyer Event Agenda

Agenda

Discover What's Happening Each Day
Day 1 25 May Day 2 26 May
Monday, 25 May

May 25 - Introduction Level

4 hours

  • Concepts and vocabulary
  • ID in Manual and Computerized Systems
  • Human factors
  • ID according to PICS and regulatory agencies
  • Deviations and more frequent problems
  • Risk management
  • Data Integrity Audit
Tuesday, 26 May

May 26 - 29 Advance Level

3 hours

  • Methodology to implement Data Integrity
  • Data Mapping and its flows
  • PDA TR80 - Laboratory Data Integrity Guide
  • Access control and electronic signature
  • Audit Trail
  • Data Integrity for Manufacturing
  • New Anvisa guide on Validation of VSC Systems
  • Good documentation practices and process flowcharts
  • Paperless and Automation
  • Qualification of technology suppliers
  • Brazilian privacy and protection law

Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Virtual Meeting

Registration

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We're currently finalizing our list of sponsors and will share the details shortly.

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