KONSEP UTAMA
! TAHAPAN PROYEK: “KUMPULAN DARI AKTIVITAS PROYEK YANG SECARA LOGIKA
SALING BERHUBUNGAN, BIASANYA DIGUNAKAN SEBAGAI BAHAN UNTUK
MENYELESAIKAN BAGIAN UTAMA YANG HARUS DIHASILKAN”
Start Finish
Time
KARAKTERISTIK SIKLUS HIDUP PROYEK
Sumber : Budi Santosa
1. Inisiasi 1. Jadual
1. Laporan Status 1. Training Kustomer
2. Analisis Kelayakan 2. Anggaran
2. Perubahan 2. Transfer Dokumen
3. Sumber Daya
3. Kualitas 3. Penugasan Kembali Staff
4. Risiko
4. Forecasts 4. Lesson Learned
5. Staffing
Concept and
Proposal
Development
Implementation
Verification
Termination
Process Development
Formulation Stability
Screening Preclinical A
Lead IND File Phase I Phase II Phase III File P
Identified Workup Clinical Clinical Clinical NDA P
Drug Sourcing IND Tests Tests Tests Postregistration Activity R
O
V
A
Metabolism L
Patent Process Toxicology
Preclinical
Discovery Screening Development Registration(s) Workup Postsubmission Activity
Operations and
Deploy
Production Support
Test Unit
Requirements
Evaluation
Subsystem
Requirements
Evaluation
System
Requirements
Risk
Analysis Business
Requirements
Proof of Conceptual
Concept Design
First Logical
Build Design
Second Physical
Build Design
Final Final
Build Design
Construct Design
SIKLUS HIDUP PROYEK - PENTINGNYA REVIEW PER TAHAPAN
Requirements Review
Proposal
General Design Review
Preparation
Requirements
Detailed Design Review
Analysis
Detailed Design
! Lakukan assesment terhadap semua aspek kebutuhan, pendekatan rancangan dan hasilnya;
PENGARUH ORGANISASI
Some organizational aspects that influence how project are performed:
Culture and style (Cultural norms)
Organizational structure
Degree of project management maturity
Project management systems
!
Projectized
Entire company is organized by projects
Personnel are assigned and report to a project manager
Composite