Labs & Compliance — GLP, GCP, GMP & ISO 15189 — Hands-on

Get a practical overview of GLP, GCP, GMP and ISO 15189 expectations for clinical and translational genomics labs. This module focuses on how these frameworks influence documentation, roles, audits and day to day operations so that bioinformatics and wet lab teams work in a compliance aware, accreditation ready way.

Labs & Compliance — GLP, GCP, GMP & ISO 15189

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Session Index

Session 1 — Lab Quality & Compliance Landscape Session 2 — GLP & GCP Concepts and Documentation Session 3 — GMP & ISO 15189 Essentials Session 4 — Mini Capstone: Compliance Checklist & SOP Map

Session 1

Fee: Rs 8800

Lab Quality & Compliance Landscape

Why compliance frameworks matter for genomics labs

patient safety and trust regulatory expectations snapshot lab reputation and partnerships

High level view of GLP, GCP, GMP and ISO 15189

where each framework applies research vs clinical settings overlaps and differences (conceptual)

Roles, responsibilities and quality culture mindset

management vs technical staff roles training and competency tracking continuous improvement idea

Session 2

Fee: Rs 11800

GLP & GCP Concepts and Documentation

Good Laboratory Practice (GLP) ideas for genomics labs

study plans and records mindset equipment logs snapshot data integrity principles (high level)

Good Clinical Practice (GCP) ideas relevant to genomics

subject protection mindset protocol and informed consent linkage (conceptual) sample handling traceability

SOPs, records and basic documentation patterns

controlled document structure logbooks and electronic records snapshot change control and version history idea

Session 3

Fee: Rs 14800

GMP & ISO 15189 Essentials

Good Manufacturing Practice (GMP) ideas touching genomics

materials and reagents control snapshot equipment qualification mindset batch records concept

ISO 15189 ideas for medical laboratories

management requirements snapshot technical requirements snapshot accreditation readiness mindset

Internal audits, deviations and continual improvement

basic internal audit cycle non conformity and corrective action ideas tracking improvements over time

Session 4

Fee: Rs 18800

Mini Capstone: Compliance Checklist & SOP Map

Start from a simple genomics lab scenario

Theory + Practical

Draft a high level compliance checklist

GLP and GCP touch points GMP and ISO 15189 touch points gaps and priority actions snapshot

Sketch an SOP and record map for the lab

key SOP titles associated forms and logs ownership and review frequency idea

PDF

Labs & Compliance — GLP, GCP, GMP & ISO 15189 Training | Compliance-Aware Genomics Labs

Labs & Compliance — GLP, GCP, GMP & ISO 15189 — Hands-on