Quality Assurance and Documentation

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.

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 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