Certificate in Quality Auditor in Clinical Research

Quality Assurance (QA) and Quality Control (QC) are the backbone of ethical, reliable, and compliant clinical research. In the highly regulated environment of clinical trials, ensuring adherence to GCP (Good Clinical Practice), SOPs, and regulatory standards is critical for data credibility and participant safety.

The Certificate in Clinical Research QA/QC Lead Auditor programme is designed to provide professionals with comprehensive knowledge of auditing techniques, quality management systems, CAPA processes, and regulatory compliance within clinical research settings.

The course equips participants with the skills to lead internal and external audits, identify process deviations, and drive continuous improvement in clinical trial operations. The curriculum aligns with global standards from ICH-GCP, USFDA, EMA, and Indian regulatory frameworks (CDSCO), preparing professionals to ensure quality oversight across trial sites, CROs, and sponsors.

Learning Outcomes

This programme will enable the participants to:

• Understand the concepts and importance of Quality Assurance and Quality Control in clinical research. • Gain in-depth knowledge of GCP, SOPs, and regulatory frameworks applicable to QA/QC operations. • Develop skills to plan, conduct, and report internal, external, and vendor audits. • Learn about deviation management, CAPA, and root cause analysis techniques. • Acquire knowledge on clinical trial documentation review, TMF/eTMF verification, and data integrity principles. • Understand inspection readiness and audit response strategies for regulatory inspections (CDSCO, USFDA, EMA, MHRA). • Apply auditing and compliance principles to maintain data quality, subject safety, and regulatory credibility. • Build leadership skills necessary to manage QA/QC teams and ensure continuous improvement across trial operations.

Target Audience

The Certificate in Clinical Research QA/QC Lead Auditor is ideal for:

• Clinical Research Professionals engaged in QA/QC, auditing, or compliance roles. • Clinical Research Associates (CRAs), Project Managers, and Data Managers seeking to advance into audit or quality leadership positions. • Quality Assurance and Quality Control personnel from pharmaceutical, biotechnology, or CRO sectors. • Regulatory Affairs professionals aiming to understand inspection and compliance frameworks. • Postgraduate students in Life Sciences, Pharmacy, Biotechnology, or Healthcare seeking careers in clinical research quality systems. 

Certified Study Resources

Module 1: Introduction to Quality Systems in Clinical Research and Clinical Trial Audit Observations

Module 2: Principles of QA/QC, GCP, and Regulatory Compliance

Module 3: Audit Planning, Types, Conduct, and Reporting – Tools and Techniques

Module 4: Deviation Management, Root Cause Analysis, and CAPA Systems

Module 5: Vendor, Site, and System Audits – Oversight and Risk-Based Approach

Module 6: Inspection Readiness, Data Integrity, and Quality Metrics in Clinical Trials

Module 7: International Organization for Standardization (ISO): ISO 9000 & ISO 9001:2015 Series

Module 8: Quality Management System in Clinical Trials 

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma, and Professional Certification programmes.

Programme Duration

The duration of the training is 5 days.

Programme Mode

Registration is currently open for Part-time (Online Live Classes) mode.

Programme Deliverables

The accompanying training is appropriately aligned with the current industry’s expectations.

• Interactive online live sessions on all key areas of the programme, offering flexibility to participants. • Simplified, practical learning facilitated by experienced IGMPI faculty members. • Module-wise assessments and evaluations designed to enhance competency and skill levels. • Feedback sessions after every module for continuous improvement. • All training and learning materials will be delivered in English. 

Assessment & Certification

All participants are required to appear for an online assessment. After successfully qualifying the examination, the participants will be awarded a Certificate in Clinical Research QA/QC Lead Auditor by the Faculty of Clinical Research, IGMPI.

Placement Assistance & Corporate Relations

The Institute has partnered with numerous organizations to provide placement assistance to its participants. The robust placement cell comprises senior-level Human Resources professionals and Talent Acquisition experts who maintain close links with business and industry.

We promote the employability of our participants by maintaining strong relationships with HR departments and recruitment teams of leading clinical research, pharmaceutical, and CRO organizations. The placement cell also assists participants with professional resume writing, interview skills, and mock interview sessions.

Our alumni and professional participants have secured positions in organizations such as IQVIA, PPD, ICON plc, Parexel, Syneos Health, Covance, Sun Pharma, Dr. Reddy’s Laboratories, Biocon, Cipla, Glenmark, and other leading global CROs and pharmaceutical firms.

The IGMPI Corporate Resource Division actively recommends trained participants for suitable job openings and specialized quality roles within the clinical research and healthcare industries.

Future Prospects

The future prospects for professionals certified in Clinical Research QA/QC Lead Auditing are exceptionally strong. With increasing global emphasis on clinical data quality, regulatory compliance, and inspection preparedness, organizations are seeking well-trained auditors and quality leaders.

Certified professionals can pursue roles such as: • Clinical QA/QC Lead Auditor • Quality Assurance Specialist • GCP Compliance Officer • Quality Systems Manager • Audit & Compliance Coordinator • Clinical Operations Quality Lead

As the number of multinational clinical trials in India and abroad continues to grow, the demand for skilled QA/QC professionals capable of ensuring ethical, accurate, and compliant research practices will expand further.

This certification opens doors to leadership roles in audit management, compliance consultancy, and quality system oversight across global CROs, sponsors, and regulatory environments.

View Prospectus

Apply Online

Last date for submitting completed Application Form: 11:59 PM 10^th Nov 2025.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in