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PDA Brazil Chapter Webinar: Auditing and Inspection/Annex 1/EMA/FDA

Jun 29 - Jul 03, 2020
1:00 PM
-
5:00 PM
| E. South America Standard Time
Online
  • Chapter
  • Online
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Overview

CONFERENCIA AUDITORIA, CONTROLES E INSPEÇÃO NA INDUSTRIA FARMACEUTICA - ONLINE

Você está convidado a participar do webinar informativo interativo do capítulo PDA Brasil sobre Junho 29- Julho 3, São Paulo

Horário - 14:00 - 17:00

Junho 29 - 30: Introdução - 4 horas

  1. Tipos de Auditoria, perfil do auditor e ética
  2. Modelos de Controle e Compliance
  3. Ferramentas e Tecnicas de Auditoria Auditoria
  4. Metodologia de Auditoria
  5. Organização de relatórios e documentação
  6. Controle de plano de ação e Auditoria continua

Julho 1 - 3: 3 horas diárias

  1. Auditoria PICS
  2. Auditoria FDA
  3. Auditoria EMA
  4. Auditoria Anvisa 
  5. Preparação para Auditoria BPF
  6. Gerenciamento de Riscos para Auditoria 
  7. Auto inspeção e Auditorias Internas

Event Flyer

Agenda

  • Day 1
  • Day 2
    • Types of Audit, auditor profile and ethics
    • Control and Compliance Models
    • Audit Tools and Techniques
    • Audit Methodology
    • Organization of reports and documentation
    • Action plan control and Audit continues
    • PICS Audit
    • FDA Audit
    • EMA Audit
    • ANVISA Audit
    • GMP Audit Preparation
    • Risk Management for Auditing
    • Self Inspection and Internal Audits

Registration Fees

Sold Out
Registration Type Price (US Dollar)
PDA Member & Non-Member $300.00

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