This training program provides comprehensive knowledge of Clinical Document Management within pharmaceutical clinical trials. It focuses on Trial Master File (TMF) management, regulatory documentation standards, document lifecycle control, and audit readiness. Participants will gain practical understanding of maintaining compliant, inspection-ready documentation aligned with ICH-GCP, FDA, and global regulatory expectations.
Course Content
Introduction to Clinical Document Management
4 Topics
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Regulatory Framework and Guidelines
4 Topics
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Trial Master File (TMF) Essentials
4 Topics
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Document Life cycle Management
4 Topics
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Electronic Document Management (eTMF)
4 Topics
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Quality Control and Audit Readiness
4 Topics
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Risk-Based Document Management
4 Topics
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Practical Case Study and Exercise
4 Topics
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Meet Your Instructor
Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners HUKSA
159 Course
13 Student
Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!
₹120,000.00
This course includes:
- Lessons 8
- Topics 32
- Duration 2-3 Days
- Quizzes 0
- Language English
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