Programme Parameters
Graduate / Intermediate
3 Days (4.5 Hrs)
Online (e-LMS)
• A basic understanding of the subject area and fundamental programming or scientific concepts.
• A laptop or desktop with a stable internet connection.
• Willingness to complete assignments and the capstone project.
About This Course
Biopharmaceutical development operates in a tightly regulated environment where non-compliance can lead to delays, rejections, or product recalls. A strong foundation in GxP principles, regulatory pathways, and high-quality documentation is essential for scientists, QA/RA professionals, and clinical teams working on biologics, biosimilars, vaccines, cell and gene therapies, and advanced therapeutics. Every participant receives a verified e-Certificate and e-Marksheet from the Deep Science & Technology Consortium.
🎯 Program Aim
Biopharmaceutical development operates in a tightly regulated environment where non-compliance can lead to delays, rejections, or product recalls. A strong foundation in GxP principles, regulatory pathways, and high-quality documentation is essential for scientists, QA/RA professionals, and clinical teams working on biologics, biosimilars, vaccines, cell and gene therapies, and advanced therapeutics.
📋 Course Objectives
1. Translate biotechnology theory into practical, reproducible analysis.
2. Build a defensible project you can showcase to supervisors, reviewers, or employers.
👥 Who Should Enroll?
• Master's and senior undergraduate students specializing in biotechnology
• R&D engineers and working professionals applying biotechnology in industry
• Academics and educators building research or teaching capacity in biotechnology
🚀 Key Learning Outcomes
• A demonstrable biotechnology project for your research or industry portfolio.
• A verified e-Certificate of competency and e-Marksheet from the Deep Science & Technology Consortium.
💎 What You'll Gain
Live & Recorded Sessions
Lifetime access to class recordingse-Certificate on Completion
Cryptographically verified credentialPost-Programme Support
Direct access to mentors & councilHands-On Experience
Notebooks, real-world code & datasetsCurriculum Outline
The GxP Family
• GLP, GCP and GMP and the distinct activities each governs
• ICH Q7 to Q12 and the quality system expectations behind them
• Regulator roles: CDSCO, FDA and EMA and where their requirements diverge
ALCOA+ in Practice
• Attributable, legible, contemporaneous, original and accurate, plus the additions
• Audit trails, 21 CFR Part 11 and computerised system validation
• Data integrity findings as a leading cause of warning letters
The Records That Constitute Compliance
• Batch records, SOPs, protocols and reports and their approval routes
• Good documentation practice: corrections, signatures and contemporaneous entry
• If it is not written down it did not happen, applied literally
Deviations and Change
• Deviation handling, root cause analysis and CAPA that addresses the cause
• Change control and its assessment of regulatory impact
• Internal audit, inspection readiness and responding to observations
Regulatory Pathways
• CTD and eCTD structure and what populates each module
• IND, BLA and marketing authorisation routes for biologics
• Biosimilar comparability and the additional demands of cell and gene therapy
Technical Specifications
| Parameter | Requirement |
|---|---|
| Covered Tool / Platform | AutoDock |
| Covered Tool / Platform | PyRx |
| Covered Tool / Platform | ChemDraw |
| Covered Tool / Platform | Discovery Studio |
| Covered Tool / Platform | ADMET Predictor |
| Covered Tool / Platform | Python |
| Covered Tool / Platform | SPSS |
Frequently Asked Questions
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