Son güncelleme: Ağustos 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 CFR Part 211
- 21 CFR Part 810
- 21 CFR Part 11
- Ek 11: Computerized Systems
- Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
- Guidance: Yazılım Doğrulamanın Genel Prensipleri
- Guidance: Klinik Araştırmalarda Kullanılan Bilgisayarlı Sistemler
- 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) işlem?
- 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
- How 21 CFR Part 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'su)
- 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 CFR Part 11 (Parça 11)
- Background and purpose of Part 11
- Overview of Part 11 (review regulation)
- Review of the Part 11 implications in regulations and guidances:
- 21 CFR Part 58 GLP
- 21 CFR Part 211 GMP
- 21 CFR Part 312 GCP (IND)
- 21 CFR Part 810 QSR
- Guidance: Parça 11 scope and application (Eylül 2003)
- Guidance: Klinik Araştırmalarda Kullanılan Bilgisayarlı Sistemler
- 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 Uyumluluk
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
Bilimsel Vaka İncelemesi
Mevcut klinik programların olup olmadığını anlamak ister misiniz?, son araştırma gelişmeleri, veya ortaya çıkan yaklaşımlar olabilir kişisel durumunuzla alakalı?
Sorunuzu bilimsel araştırma ekibimizle paylaşın ve olabilecek güncel araştırma alanlarına odaklanan bilgiler sizin durumunuzla alakalı.
- Sağladığınız bilgilerin gözden geçirilmesi
- İlgili araştırma ve klinik program bilgileri
- Durumunuza odaklanmış net bir yanıt
Sonra ne olacak??
Sorunuzu gönderin, odaklanmış bir bilimsel inceleme almak, ve durumunuzla ilgili araştırma ve klinik programlar hakkında net bir yanıt alın.
Bilimsel incelemeniz şu şekilde hazırlanacaktır: Dr.. Helen Melnik, Doktora , kimin daha fazlasına sahip 25 yılların tecrübesi kök hücre araştırmalarında ve uluslararası klinik programlarda.
Hiçbir yükümlülük yok. Sorunuz gizli olarak incelenecektir.
Yalnızca eğitim ve araştırma bilgileri. Bu hizmet tıbbi tavsiye teşkil eder, teşhis, reçete, veya kişiselleştirilmiş tedavi önerisi.
