Onsite Courses

CURRICULUM FOR ONSITE / ON CAMPUS COURSES

GXPZONE PHARMA ACADEMY has also designed a Compact course containing twelve modules which gives a complete overview of the pharmaceutical industry, the individual course modules gives a detailed information of all the auditable departments such as Quality Assurance, Quality Control, Production, Warehouse, Regulatory and Engineering.

This complete course is a package which refines a college pass out students and make them Industry ready. All the training are imparted by the experienced pharma professional who will be a Subject Master Expert of the specific course module.

This complete course includes

1. 1. Student Registration
  2. Comprehensive training of all modules for a period of 6 weeks (Classes will be conducted twice in a week)
  3. Industry Visit – coordination
  4. Question & Answer
  5. Mock Test
  6. Interview
  7. Certification
  8. Placement Assistance

Procedure: For conducting Onsite/ On campus courses minimum twenty five student’s batch should be there. Courses will be conducted within the college Campus with due permission of the Faculty / Administration.

Total course fees details along with the course details/contents will be send on request. Please write a Email at admissions@gxpzonepharmaacademy.com.

Student should download the registration form from the website and the same can be uploaded along with the fees which can be paid through cheque or online.

List of Training Modules and Contents

Training Topics : Introduction to Pharmaceutical Industry

Training Module No : TRMGXP-01

Contents :

- Evolution of the Indian pharmaceutical industry
- Introduction
- Major Player
- SWOT Analysis
- Indian Scenario
- Global Scenario
- Future Outlook

Training Topics : Regulations and Acts Prevailing in the Pharma Industry

Training Module No : TRMGXP-02

Contents :

- Drug & Cosmetic Act and Schedule M
- US Regulations 21 CFR Part 210 & 211
- MHRA guidelines (Orange Book)
- EU GMP Guidelines

Training Topics : Facility, Equipment and Utility System Qualifications

Training Module No : TRMGXP-03

Contents :

- Concept and requirements
- Facility Qualification (Area Qualification)
- Equipment Qualification (All critical and major equipment’s/Instruments)
- Utility Qualification (HVAC, Compressed Air, Nitrogen)
- Analyst Qualification

Training Topics : Quality Assurance I (Validations)

Training Module No : TRMGXP-04

Contents :

- Cleaning Validation
- Process Validation
- Analytical Method
- Computer System Validation
- PLC Validation
- Transport Validation
- Media Fill

Training Topics : Quality Assurance II (QMS)

Training Module No : TRMGXP-05

Contents :

- Site Master FIle
- Validation Master Plan
- Quality Manual
- Quality Management System
- Change control Management
- Deviation Management
- Out of Specification
- Market Complaint
- Corrective and Preventive Action
- Product Call
- Self Inspection /Internal Audit
- APQR

Training Topics : Quality Control

Training Module No : TRMGXP-06

Contents :

- Laboratory Control System
- Procedure and control related to QC lab
- Functions of Quality Control
- Sampling of RM/PM
- Analysis of RM/PM
- Specification & Method of Analysis (MOA)
- Review of Analytical Data (Hard / Electronic)
- Calibration of Various Instrument (HPLC, GC, UV, IR, AAS, Titrator, Balance)
- OOS, OOC and OOT

Training Topics : Production (Production Life Cycle and Critical Control Area

Training Module No : TRMGXP-07

Contents :

- Demonstration of Production Process
- Granulation
- Compression and Die Punch Management
- Coating
- BMR , Batch Manufacturing Record
- FBD bags, Sieves and Screens Management