Última atualização: Agosto 17, 2026
Course Agenda
Computer Validation General Overview
- Computer Validation fundamentals a walk-through of a complete validation of a small example system
- Who needs to validate?
- What is Computer Validation?
- Core principles
- Brief history of computer validation
- Why is validation necessary and what regulations guide validation requirements?
- Review of the computer validation references in regulations and guidances:
- 21 Parte CFR 211
- 21 Parte CFR 810
- 21 Parte CFR 11
- Anexo 11: Computerized Systems
- Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
- Guidance: General Principles of Software Validation
- Guidance: Computerized Systems Used in Clinical Investigations
- When and how are systems validated?
- Review of key FDA Warning Letters related to computer validation
Computer Validation Process and Deliverables
- What is the SDLC (System Development Life Cycle) processo?
- How does computer validation fit into the SDLC?
- What content must be covered?
- What are the expected tasks and deliverables?
- System/software specifications
- Requirements options and documentation
- Como 21 Parte CFR 11 applies to computer validation
- Design Qualification (DQ) and vendor selection
- Risk Assessment in computer validation
- Where does it apply?
- A walkthrough of the GAMP risk assessment process
- Validation Plans and Master Validation Plans
- Installation Qualification (IQ)
- The five topics expected in IQ documents
- Operational Qualification (OQ) and Performance Qualification (PQ)
- Testing strategies and level of detail
- How much testing is enough?
- Examples of effective test cases and system errors discovered
- SOPs required for system operation and maintenance
- How they related to FDA Warning Letters
- Validation Summary Reportse
Overview of 21 Parte CFR 11 (Papel 11)
- Background and purpose of Part 11
- Overview of Part 11 (review regulation)
- Review of the Part 11 implications in regulations and guidances:
- 21 Parte CFR 58 BPL
- 21 Parte CFR 211 BPF
- 21 Parte CFR 312 GCP (IND)
- 21 Parte CFR 810 QSR
- Guidance: Papel 11 scope and application (Setembro 2003)
- Guidance: Computerized Systems Used in Clinical Investigations
- Guide to the Inspection of Pharmaceutical Laboratories
- Review of Part 11-related FDA Warning Letters
- Discussion of example systems and the evaluation of Part 11 Compliance decisions
- Industry trends and approaches the future of Part 11 issues
- Interactive discussion of Part 11 issues and concerns (bring your questions)
- Achieving and Maintaining Part 11 Conformidade
GAMP-Specific Computer Validation Topics
- The industry guidance for Good Automated Manufacturing Practice (GAMP)
- How GAMP addresses the FDA’s expectations for computer validation
- GAMP 5 versus GAMP 4
- How to transition to GAMP 5 from GAMP 4
- A review of the supplementary GAMP guidances and where they apply
Auditing Computer Systems
- Auditing GxP computer systems
- Auditing suppliers of computer systems for GxP use
- Auditing developers for customized systems
- The general process for auditing computer systems
- Variations that can save time and money
- Review of an example audit checklist
- Primary areas of focus (what to look for)
- Examples of audit findings
Revisão de Caso Científico
Você gostaria de entender se os programas clínicos atuais, desenvolvimentos de pesquisa recentes, ou abordagens emergentes podem ser relevante para sua situação individual?
Compartilhe sua dúvida com nossa equipe de pesquisa científica e receba informações focadas nas áreas de pesquisa atual que podem ser relevante para o seu caso.
- Revisão das informações que você fornece
- Informações relevantes sobre pesquisas e programas clínicos
- Uma resposta clara focada na sua situação
O que acontece a seguir?
Envie sua pergunta, receber uma revisão científica focada, e obter uma resposta clara sobre pesquisas e programas clínicos relevantes para sua situação.
Sua revisão científica será preparada por Dr.. Helen Melnik, Doutorado , quem tem mais de 25 anos de experiência em pesquisa com células-tronco e programas clínicos internacionais.
Sem obrigação. Sua pergunta será analisada confidencialmente.
Apenas informações educacionais e de pesquisa. Este serviço não constituem aconselhamento médico, diagnóstico, prescrição, ou um personalizado recomendação de tratamento.
