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bullet] Oct 29, 2006
The AIPT Opened a Health Science Division to offer Healthcare / Nursing related courses at newest state of the art facility in Central New Jersey, USA ..
bullet] March 16, 2007
The AIPT is going to Offer Executive MBA program in Kolkata, India from August 2007.
 
 
   
 
 
US Campus | Canada Campus
   
  Courses blue US Campus blue PG Diploma Courses
   
 
PHARMACEUTICAL VALIDATION SCIENTIST/ ENGINEER    
COURSE :  IC-104 Duration : 12 months
  Qualification : Minimum BE / IT / BS
   
 
Module - 1(Basic):
 

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

green OSHA, SAFETY
green cGMP
green Documentation
green 21 CFR (part 11electrical signature and audit trail)
green Basic information about pharmaceutical drug, resolutions.
green The role of key operational units in drug manufacturing processes.
 
 
Module – 2 (Intermediate):
 

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

 
green Requirements in Validation documentation
green Validation Plans (VP)
green Design Qualification (DQ) and vendor selection
green Installation Verification/Qualification (IQ)
green Operational Verification/Qualification (OQ)
green Performance Verification/Qualification (PQ)
green Risk Assessment and Review.
green Final Reports
green Validation Summary Reports (VSR)
 
   
 
Module – 3 (Advanced):
 

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.

Course includes:
green Method Validation techniques.
green Calibration and maintenance in pharmaceutical industry.
green During validation trouble shooting in detail and their parameters that governs Validation.
green Manufacturing parts identification and purchase from the vendors.
green Basic idea for cleaning validation in CFR 21 part 210 and 211. FDA regulations in R&D department.
   
 
Module – 4 (Internship):
 

Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience through working with staff and faculty on one of the many unique projects undertaken at the Institute.

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