Certificate Program in Quality Assurance in Clinical Research
Certificate
Distance
Description
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Type
Certificate
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Methodology
Distance learning
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Location
Bhopal
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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
Facilities
Location
Start date
Start date
About this course
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.
Reviews
Course programme
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
Certificate Program in Quality Assurance in Clinical Research