InstructorKnowledge Process Enhancer
TypeOnline Course
Price$490 / Rs. 24500
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Introduction

Objective

Features

Duration

Certification

quality assurance and documentation

Course Title: KPE’s Certificate Program in Quality Assurance and Documentation.

Course Code: KPE-C-015

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 focuses on the advance practical learning, keeping in view what Quality Assurance professionals handles and additional content what helps them to enrich the knowledge base to take further growth in the career.

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.

Course Feature:

  • Orientation to practical understanding in the entire quality assurance process in pharmaceutical companies with practical exposure on quality documentation.
  • Simulation to real life Strategic planning in handling quality management system and documentation.
  • Course provides advance learning on the handling and management of the plant inspection.
  • Attend 24×7 e-lectures of all different chapters and study content.
  • Attend the simulations, self assessment modules to evaluate the self competency.

1 Month

Course certification will be issued on completion of the final examination.

Course Flow

Section 1Drug Discovery Development to Commercialization Training
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3Basic concept and understanding of the Generic Drug
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Understanding the concept of authorized generics
Lecture 7Patent & Exclusivity Training - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 8Advance Understanding on Clinical Trial and Clinical Trial Management
Lecture 9Evergreening - Patent Life Extension Strategies
Lecture 10LOE Strategies for Innovator Brands with case study
Section 2Marketing Authorization Submission & Dossier Preparation Training
Lecture 11Submission Strategic Pathways : 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Chemistry, Manufacturing & Controls 
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14FDA Forms and How to fill the resources
Lecture 15Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 16Advance study on Para IV Filing
Lecture 17Para IV Notices
Lecture 18Introduction to Common Technical Document (CTD)
Lecture 19Introduction to Electronic Common Technical Document (ECTD)
Lecture 20Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 21Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 22Black Box Warning
Lecture 23Importance of effective dossier management
Lecture 24Certificate of Analysis
Lecture 25Detailed Understanding on ANDA Submission Dossier 
Lecture 26Prior Approval Submission 
Lecture 27Key Consideration for Drug Master File Preparation and Submission 
Lecture 28Practical Understanding on Drug Master File Preparation and Submission
Lecture 29Associated Learning: Site Master File - Detailed Understanding 
Lecture 30DMF Completeness Assessment
Lecture 31Drug Master File - Fees
Lecture 32Drug Master File - Global Perspective [Across Different Regions]
Lecture 33Detailed Understanding on ANDA Fees
Lecture 34Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 35NCE Vs. 505b2 application - Case Based Learning 
Lecture 36FTF - 180 Days Exclusivity - Case Based Learning
Lecture 37Classic case study of the 505b2 filing : Case Based Learning
Lecture 38Discussion on 85 common deficiency in CTD submission dossier
Lecture 39Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 40Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 41Summary of Product Characteristics 
Lecture 42Marketing Authorization Variation Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Section 3GMP - Quality Management System; Plant Inspection
Lecture 43GMP - Introduction and Important Discussion
Lecture 44Certification Pharmaceutical Companies / Plants
Lecture 45ISO Certifications
Lecture 46Premises & Plant Layout Designing
Lecture 47Sanitation and Hygiene
Lecture 48Equipment
Lecture 49Production Module
Lecture 50Documentation
Lecture 51Quality Control
Lecture 52Product Complaint
Lecture 53Storage Module
Lecture 54ISO and ISO Audits
Lecture 55Pharmaceutical SOPs Management from regulatory perspective
Lecture 56SOP Automation in Pharmaceutical Industry
Lecture 57Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 58Advance Training on Effective Management of Data Integrity issues in Pharmaceutical Industry
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