The basic module is designed to provide students an in-depth knowledge of pharmaceutical Technology, bio-pharmac

The intermediate module focuses on practical training in pharmaceutical Validation experimental design. Hands-on experience is acquired through team-based projects, in compliance with GMP and GLP, in our state-of-the-art QC laboratories and manufacturing plant Validation. This course design for IT personnel to get depth knowledge of pharmaceutical industries computer system validation with FDA guidelines, In addition, the course will cover 21 CFR Part 11 (electronic record/electronic signature requirements). The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Validation Process and Deliverables

The advanced module provides an opportunity to engage in independent Validation and IQ/OQ/PQ projects / process. The focus is on drug delivery, dosage form design, process development and scale-up technology using computer system.