Certificate Program in Quality Assurance in Clinical Research


Rs 60,000
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Important information

  • Certificate
  • Distance learning
  • Bhopal
  • Duration:
    6 Months

Course Objectives. To increase the understanding of Quality assurance process in Clinical research. To understand importance of QA in Clinical research. Learn the essentials skills, processes, knowledge and competencies to be a QA Professional

Important information

Where and when

Starts Location
On request
Medical Director Cliniminds Unit of Tenet Health Edutech Pvt. Ltd. C-55, 1st Floor, Preet Vihar, Main Vikas Marg, 110092, Delhi, India
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Frequent Asked Questions

· Requirements

MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.

Course programme

The program has been developed to provide comprehensive training on the process of Quality
assurance in clinical research. The program is targeted towards both, the working professionals
and the students who would like to take QA in Clinical research as career option:
 History of Drug Regulations
 Introduction and role of Quality Assurance in CRO
 QA activities in CRO
 Quality Assurance Plan
 Operational QC
 SOP for QA activities in CRO
 Site Management metrics
 Study site audits
 Internal audits types - in process and retrospective data audits, system and process audits
Data management metrics Statistical analysis metrics
 Corrective and preventive action
 Continual improvement process
 An overview of different regulatory agencies-FDA,EU and DCGI

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