Login
Online Course Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
Science And Technology

Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)

Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) are internationally recognized quality systems that ensure the safety, reliability, and integrity of clinical and laboratory research data. In modern biomedical and pharmaceutical industries, adherence to GCP and GLP guidelines is essential for maintaining ethical standards, ensuring regulatory compliance, and producing accurate and reliable research outcomes.conducting ethical clinical trials and maintaining laboratory quality standards.
Course ModeHybrid
Duration1 Week
Starts13 Aug 2026
Ends19 Aug 2026
Course Fee
₹1,000 /-
Registration Closed
About The Course

Overview

Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) are internationally recognized quality systems that ensure the safety, reliability, and integrity of clinical and laboratory research data. In modern biomedical and pharmaceutical industries, adherence to GCP and GLP guidelines is essential for conducting ethical clinical trials and maintaining laboratory quality standards. With the rapid expansion of clinical research and pharmaceutical industries, there is a growing demand for professionals trained in regulatory compliance, quality assurance, documentation, and ethical research practices. This course is designed to provide participants with theoretical understanding and hands-on exposure to GCP and GLP principles, enabling them to function efficiently in clinical laboratories, research organizations, and pharmaceutical industries.

This certification course aligns with NEP-2020 objectives by promoting skill-based learning, practical exposure, and industry readiness among students and professionals.

 

 COURSE OBJECTIVES

The primary objectives of the certification course on GCP & GLP are the following:

  • To introduce the fundamental principles of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
  • To provide knowledge about clinical trial design and regulatory requirements.
  • To develop competency in laboratory quality systems and SOP development.
  • To familiarize participants with regulatory compliance and audit procedures.
  • To enhance understanding of documentation practices and data integrity.
  • To provide practical exposure to safety management and laboratory ethics.
Learning Goals

Course Outcomes

Upon successful completion of the course, participants will be able to:

  • Understand international GCP and GLP regulatory frameworks.
  • Demonstrate knowledge of clinical trial procedures and documentation.
  • Apply quality assurance principles in laboratory settings.
  • Perform standard documentation and maintain laboratory records.
  • Understand audit and inspection procedures.
  • Implement safety protocols and ethical standards in research.
Curriculum

Course / Modules

Module 1: Introduction to GCP & GLP (2 Hours)

  • Principles of Good Clinical Practice
  • Principles of Good Laboratory Practice
  • Regulatory agencies (ICH, CDSCO, WHO)
  • Ethics in clinical and laboratory research
  • Overview of quality systems

Module 2: Clinical Trial Design & Documentation (2 Hours)

  • Phases of clinical trials
  • Investigator responsibilities
  • Case Report Forms (CRFs)
  • Informed consent process
  • Protocol development

Module 3: Laboratory Quality Systems (2 Hours)

  • Laboratory organization
  • Standard Operating Procedures (SOPs)
  • Equipment validation
  • Calibration and maintenance
  • Documentation practices
  • Log Book

Module 4: Regulatory Compliance & Audits (2 Hours)

  • Regulatory requirements
  • Internal and external audits
  • Inspection readiness
  • Corrective and Preventive Actions (CAPA)

Module 5: Data Integrity & Documentation (2 Hours)

  • ALCOA+ principles
  • Record keeping
  • Electronic data management
  • Data validation and security

Module 6: Safety, Risk Management & Applications (2 Hours)

  • Risk assessment
  • Biosafety practices
  • Laboratory waste management
  • Clinical-laboratory integration
  • Final evaluation and certification
Learn From Experts

Our Trainers

Dr. Ganesh Narayanan
Dr. Ganesh Narayanan
Name                        &n...
Prof. C. S. Mujeebuddin
Prof. C. S. Mujeebuddin
Experienced clinical research professional with nearly two decades of experience in the pharmaceutical and clinical research industry. Expertise in cl...
Dr. Mugil Murya
Dr. Mugil Murya
Clinical Research Professional with 20+ years of experience in clinical trial management, regulatory compliance, and clinical operations across global...
Need Help?

Frequently Asked Questions

1. What is the duration of the GCP & GLP course?
The course duration is 1 week, scheduled from 18 June 2026 to 23 June 2026, including theory and practical sessions.

2. What topics will be covered in this course?
The course includes clinical trial design, SOP development, regulatory compliance, audit procedures, data integrity (ALCOA+), documentation practices, and laboratory safety management.

3. Who can apply for this course?
Students and professionals from BMLT, DMLT, Pharmacy, Biotechnology, Life Sciences, Clinical Research, Lab Technician, and related healthcare fields are eligible to enroll.

4. What mode will the course be conducted in?
The course will be conducted in hybrid mode at the Clinical Research Unit of the university campus.

5. Will participants receive a certificate after completion?
Yes, participants who successfully complete the course and final evaluation will receive a certificate in Good Clinical Practice (GCP) & Good Laboratory Practice (GLP).

Need More Information?

Contact

Name: Dr. N. Ganesh

Mobile No: 9826321616

Email: [email protected]