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:
- 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.
Our Trainers
Dr. Ganesh Narayanan
Name : Dr.N.Ganesh
Designation : Dean (Clinical Research & Research Consultancy)
Department Affiliation : Administration, Sanjeev Agarwal Global Educational (SAGE) University, Bhopal (M.P)
Education Qualification : PhD Anatomy (Medicine Faculty 2002)
MSc. Genetics, Diploma Human Nutrition (Alison, Ireland, UK 2021), Diploma Allopathy (Council of Indian Paramedical & Vocational Faculty 2019), Diploma Computer application, Certificate course & Observership in Clinical Genetics, Cancer Genetics, Industrial Microbiology, Counselling, Aromatherapy & Clinical Andrology).
Experience in SAGE : 4 months 19 days
Experience outside SAGE : 28 Years as a Consultant Oncogenetics & Sr.
Scientist
Work Area & Expertise : Diagnostic Human Genetics, Cancer Genetics,Immunogenetics,
Pedigree charting, Genetic Counselling, Tumor research, In – vitro Human and Animal Tissues culture, Bone marrow Culture, Toxicology, Experimental Pharmacology, Dermatoglyphic, Human Anatomy, Clinical Biochemistry, Clinical Microbiology, Mutation Research, Bio-statistic, Clinical Trial, Pre-clinical Trial, Laboratory Design, Textile Design & Fine Art.
Research Credentials
Publications : 169 published, 6 communicated
Research Citation Score : 68704
H - index : 131
i10 - index : 864
Books/Book Chapters : 2 Books, 2 Chapters, 1 book under process.
IPR : 2 & 1 Filed
Projects : 22 completed (Rs. 4,35,28,328.00) & 2 Submitted (Rs.70,63,000.00)
PhD Guide : 22 (Awarded) & 4 (Submitted)
Awards : 52 (National & International), 89 (Best Scientific
Paper) & 72 (Best poster)
Health & Cancer Awareness : 27300
Prof. C. S. Mujeebuddin
Experienced clinical research professional with nearly two decades of experience in the pharmaceutical and clinical research industry. Expertise in clinical operations, pharmacovigilance, regulatory affairs, and project management across global Pharma CRO and Pharma-IT organizations. Founder of ClinoSol Research Pvt. Ltd., contributing significantly to skill development and placement in clinical research.
EXPERIENCE
Founder & Director
ClinoSol Research Pvt. Ltd. | 2019 – Present
- Established a leading clinical research training and placement organization
- Trained students from Medical, Dental, Pharmacy, and Life Sciences backgrounds
- Expanded operations across India and Canada
- Supported thousands of learners toward global careers
Clinical Research Professional
Worked with leading global organizations including:
QPS | Parexel | Accenture | Oracle | IQVIA
- Managed clinical operations and pharmacovigilance activities
- Handled regulatory affairs and project management roles
- Supported clinical research workflows across global project
KEY ACHIEVEMENTS
- Founder of ClinoSol Research Pvt. Ltd.
- Academia Partner at national and international conferences including ISCR and SCDM
- Placement Coordinator for Indian Pharmaceutical Association (IPA)
- Delivered expert talks at major academic and technology platforms including G20 Tech Summit
- Led organization to receive 13 prestigious awards, including highest placement recognition (2023)
EDUCATION
M.Pharm
MSc.
Dr. Mugil Murya
Clinical Research Professional with 20+ years of experience in clinical trial management, regulatory compliance, and clinical operations across global pharmaceutical and CRO organizations. Expertise in site monitoring, regulatory submissions, project management, and quality systems with strong leadership in multi-center clinical trials and public health programs.
EXPERIENCE
Director – Clinical Operations
ProClin Research Pvt. Ltd., India
2019 – Present
- Leading clinical research operations and project management
- Managing clinical trial teams and regulatory processes
- Overseeing CTMS, eTMF, and Veeva systems administration
Consultant
Foundation of Innovative New Diagnostics (FIND), Geneva
University of California, San Francisco
Lead Clinical Analyst & Monitoring Lead
IQVIA (Quintiles)
2015 – 2018
Global Lead Clinical Research Associate
Novartis
2014 – 2015
Clinical Research Associate
Quintiles & InVentiv (Sanofi Projects)
2012 – 2014
Clinical Research Coordinator
Jawaharlal Nehru Cancer Hospital & Research Centre
2007 – 2012
EDUCATION
Ph.D. Public Health
Mansarovar Global University, India | 2024
M.Sc + Integrated Ph.D. Clinical Research
Cranfield University, UK (with ICRI India)
B.Sc Life Sciences
University of Delhi, India
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
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.
FAQs
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).
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