Course Title: KPE’s Certificate Program in Quality Assurance and Documentation.
This online course utilizes interactive learning tools to guide each participant through the steps of quality assurance working and managing quality documentation procedures in pharmaceutical companies. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
The objective of this course is to impart knowledge and practical understanding about the Quality Assurance department and core quality assurance method, process and practices. Special emphasize on quality documentation process handling.
1. Orientation to practical understanding in the entire quality assurance process in pharmaceutical companies with practical exposure on quality documentation.
2. Simulation to real life Strategic planning in handling quality management system .
3. Access to industry case studies.
4. Attend Live Lectures of all different chapters / study content.
The Internationally Accredited course – Accredited by International Association of Distance Learning (IADL), UK
Knowledge Process Enhancer is registered under Trademark Registry of India, under class 42.
This course is divided into following modules
1. Overview of quality assurance in pharmaceutical and allied companies.
2. Difference between QA and QC. Understanding distinct job profile of the quality professionals.
3. Practical knowledge about the workflow in QC and QA department.
4. Detailed understanding of the Quality Documentation
5. Assessing the Quality Control Tests and parameters for starting , semi finished and finished formulation.
6. Handling of the Product Complaint & Product Recall.
7. Handling of Product Withdrawal from market.
8. Newer Innovations in Quality Assurance strategies
9. GMP in Pharmaceutical Industry
Introduction to Good Manufacturing Practices
Premises & Plant Layout Designing
Sanitation and Hygiene
10. Warning Letter – Handling
USFDA Warning Letter
Handling of warning letter
11. Handling of Internal Audit
QA detailed Study
12. SOP Management for better effectiveness of plant
Pharmaceutical SOPs Management from regulatory perspective
SOP Automation in Pharmaceutical Industry
13. Formulation, Quality and Regulatory Manual for handling CAPA
Introduction to CAPA
Root cause analysis and handling of deviations
Regulatory plant audit handling and liaising with the regulatory department