Dengan Hormat,
GLP adalah singkatan dari Good Laboratory Practice, yaitu sistem manajernen laboratorium yang memastikan kualitas pengujian. GLP mencakup aspek teknis dan manajemen, serta bertujuan untuk menghindari kecelakaan kerja
GLP meliputi:
1. Organisasi laboratorium
2. Fasilitas laboratorium
3. Tenaga kerja laboratorium
4. Metode analisis
5. Pelaksanaan analisis
6. Monitoring
7. Pencatatan dan pelaporan
8. Kondisi sarana dan prasarana laboratorium
TUJUAN PELATIHAN GLP Good Laboratory Practice TAHUN 2025
Untuk memberikan pemahaman tentang praktik laboratorium yang berkualitas. Pelatihan ini juga
bertujuan untuk memastikan data yang dihasilkan laboratorium dapat diandalkan dan diuji ulang
MATERI PELATIHAN GLP Good Laboratory Practice TAHUN 2025
- Konsep Sistem Good Laboratory Practices
- Sejarah perkembangan GLP-Good Laboratory Practices System
- Perbandingan serta kesamaan GLP System dengan ISO/IEC 17025
- Organisasi Laboratorium
- SDM Laboratorium
- Keselamatan Kerja di Loratorium (Laboratory Safety)
- Sistem Jaminan Mutu Laboratorium
- Kondisi Akomodasi dan Lingkungan
- Metode Pengujian Dan Kalibrasi Serta Validasi Metode
- Peralatan, Instrumen, Pereaksi dan Perangkat Laboratorium Lainnya
- Sistem Dokumentasi, Standard Operating Procedure-SOP, Kontrak Kerja
- Pengambilan Contoh (Sampling)
- Penanganan Barang yang Diuji
- Pelaporan Hasil uji
- Dokumentasi dan Rekaman
- Inspeksi dan Assesmen
Untuk itu Pemerintah Daerah haruslah merniliki pengetahuan dan pemahaman yang optimal mengenai Opsi di Atas untuk itu kami LATIHNAS PENGEMBANGAN MANAJEMEN Meyelengarakan PELATIHAN GLP Good Laboratory Practice TAHUN 2025.
PROSEDUR PENDAFTARAN
- Surat beserta jadwal kegiatan akan dikirim setelah melakukan konfirmasi ke kami.
- Surat beserta jadwal dapat dikirim melalui Faximile/Email atau WhatsApp.
- Bagi Peserta minimal 6 orang dapat menentukan waktu, tempat dan materi kegiatan.
- Pendaftaran peserta paling lambat 5 hari sebelum pelaksanaan kegiatan.
- Materi sesuai jadwal yang telah terlaksana bisa dijadwalkan kembali sesuai keinganan peserta.
A certificate of Good Laboratory Practice (GLP) verifies that a laboratory adheres to internationall
recognized standards for conducting non-clinical studies, ensuring the quality and reliability of
research data. These certificates are issued by competent authorities upon successful completion of
inspections and audits of testing facilities. GLP principles cover various aspects of laboratory operations, including:
Organization and Personnel: Defining roles, responsibilities, and qualifications of staff.
Facilities and Equipment: Ensuring appropriate infrastructure and calibration of instruments.
Test and Reference Substances: Proper handling, storage, and characterization of materials.
Standard Operating Procedures (SOPs): Documented procedures for all laboratory activities.
Study Conduct: Following established protocols and maintaining accurate records.
Reporting and Archiving: Ensuring proper documentation and archiving of all study-related
information. Here’s a more detailed breakdown of what a GLP certificate syllabus might include:
Core GLP Principles & Concepts:
Introduction to GLP:
Understanding the history, purpose, and scope of GLP, including its role in regulatory compliance and
quality assurance.
GLP Principles:
Detailed study of the core principles of GLP, such as study planning, conduct, reporting, and
archiving, as defined by organizations like the OECD and FDA.
Quality Assurance (QA):
Learning about the role of QA in GLP, including the development and implementation of QA
programs, internal and external audits, and corrective actions.
Specific GLP Areas:
Documentation:
Focusing on the importance of proper documentation in GLP, including study plans, raw data, final
reports, and standard operating procedures (SOPs).
Laboratory Management:
Understanding the requirements for laboratory management, personnel, facilities, equipment, and
materials, ensuring they meet GLP standards.
Method Validation:
Learning how to validate analytical methods used in GLP studies to ensure they are fit for purpose
and produce reliable results.
Data Integrity:
Understanding the principles of data integrity, including data security, access control, and the
prevention of data manipulation or falsification.
Computerized Systems:
Exploring the specific requirements for computerized systems used in GLP, including validation, data
security, and audit trails.
Regulatory Aspects:
GLP Regulations:
Studying the specific GLP regulations of relevant regulatory bodies, such as the OECD and the FDA.
Accreditation:
Understanding the process of laboratory accreditation, including the requirements of organizations
like ISO/IEC 17025.
Training Methods:
Online Courses:
Many institutions offer online, self-paced GLP training, which may include video lectures, quizzes,
and downloadable resources.
In-Person Workshops:
Some institutions offer in-person workshops with hands-on training and opportunities for interaction
with GLP experts.
Examinations:
To earn a GLP certificate, individuals often need to pass an exam that assesses their understanding of
GLP principles and practices.
INVESTMENT:
Onsite Training: Rp 10.500.000
Via Zoom: Rp 9.500.000
