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

May 25 - May 28, 2020
7:00 AM
-
5:00 PM
| E. South America Standard Time
Online
  • Chapter
  • Online

Overview

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

  • Day 1
  • Day 2
  • 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
  • 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

Registration Fees

Register Now
Registration Type Price (US Dollar)
PDA Member & Non-Member $300.00

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