Faculty of Clinical Research and Drug Safety (FCRDS) has been set up under the aegis of ‘Institute of Good Manufacturing Practices India' - an autonomous Institute recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI), presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food, Nutraceutical, Nutrition industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition, Environment and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC, etc., areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

    1. Course Content
    2. Course Design
    3. Course Material
    4. Instructors
    5. Class size & Attendance
    6. Facilities
    7. Evaluation of Students
    8. Written Examination
    9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI is also approved by Sector Skills Council under National Skill Development Corporation (NSDC) setup by Ministry of Skill Development & Entrepreneurship, Govt of India (TC ID:TC342267).

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

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

International Affiliation with

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.