Certificate Course In Pharmaceutical Data Integrity

Pharmaceutical Industry, Drug Regulatory Compliance, Data Breach, FDA, GMP, Warning Letter, Import Alert, Product Recall

What you'll learn

Basic Understanding of Data Integrity

Data Integrity and Regulatory Requirements

Importance of Data Integrity

Important Terminologies Related to Data Integrity

ALCOA, ALCOA+, ALCOA++

Types of Data Integrity

Breach in Data Integrity

Factors Leading to Data Integrity Issues

Summary of Data Integrity Issues

Ways to Minimize Data Integrity Risk

Role of Management Related To Data Integrity

Role of Staff Members Related To Data Integrity

Data Integrity-Do's And Don'ts

Audit New Approach and Lesson

Personnel Integrity and Ethics

Today's Necessity Related To Data Integrity

Advantages And Disadvantages of Data Integrity

Requirements

Strong Desire to Understand The Importance Of Data Integrity And Regulatory Compliance In The Pharmaceutical Industry

Basic Level Of English Proficiency

Reliable Internet Connection And Access To A Desktop, Laptop, Or Smartphone (Since The Course Is available In Online Mode)

Basic Knowledge Of The Pharmaceutical Or Medical Field Is Helpful

Description

If you find pharmaceutical data integrity and drug regulatory compliance challenging, this comprehensive course is tailored for you.The pharmaceutical industry operates within a highly regulated landscape, with numerous government regulations to protect public health and ensure the safety, efficacy, and quality of pharmaceutical products. This course provides a deep understanding of pharmaceutical data integrity and regulatory compliance, equipping you with the necessary knowledge and skills to excel in this vital field.The course focuses on the following key areas to help you navigate the complexities of data integrity and regulatory compliance:• Basic Understanding of Data Integrity• Data Integrity and Regulatory Requirements• Importance of Data Integrity• Important Terminologies Related to Data Integrity• ALCOA, ALCOA+, ALCOA++• Types of Data Integrity• Data Integrity Breach• Factors Leading to Data Integrity Issues• Summary of Data Integrity Issues• Ways to Minimize Data Integrity Risk• Role of Management Related To Data Integrity• Role of Staff Members Related To Data Integrity• Data Integrity-Do's And Don'ts• Audit New Approach and Lesson• Personnel Integrity and Ethics• Advantages And Disadvantages of Data Integrity• Many moreThere will be several downloadable documents so that you can follow along with them whenever you need them.This course contains Commonly Asked Questions that will help you while preparing for Pharma interviews focusing on Data Integrity and related issues.Last but not least, this course also contains a bonus course entitled "Meeting etiquettes" which will help you shape your career in which the points that must be taken into consideration while attending/conducting meetings are covered.In this course, more than 25 informative videos are included and are designed in an easily digestible format to take you through step by step approach to understanding Pharmaceutical Data Integrity and related information.I believe "Quality improvement is a continuous and lifetime process". Upon completion of this course, you will be a whole different professional with improved skills and knowledge related to Pharmaceutical Data Integrity and Drug Regulatory Compliance which will help you to garner more respect from your team members, managers, clients, or anyone with whom you are communicating/interacting.

Overview

Section 1: Data Integrity-Introduction

Lecture 1 Introduction-Basic Understanding of Data Integrity

Lecture 2 Historical background of US Drug Law and Regulations

Lecture 3 Drug Approval Process

Lecture 4 Good Manufacturing Practices_Introduction

Lecture 5 Good Manufacturing Practices_GMP Principles

Lecture 6 GMP Vs cGMP

Section 2: Data Integrity-Deep Dive In To The Topic

Lecture 7 Data Integrity and Regulatory Requirements

Lecture 8 Importance of Data Integrity

Lecture 9 Important Terminologies Related to Data Integrity Part 1

Lecture 10 Important Terminologies Related to Data Integrity Part 2

Lecture 11 Important Terminologies Related to Data Integrity Part 3

Lecture 12 ALCOA, ALCOA+, ALCOA++ Part 1

Lecture 13 ALCOA, ALCOA+, ALCOA++ Part 2

Lecture 14 ALCOA, ALCOA+, ALCOA++ Part 3

Lecture 15 Types of Data Integrity Part 1

Lecture 16 Types of Data Integrity Part 2

Lecture 17 Data Integrity Breach Part 1

Lecture 18 Data Integrity Breach Part 2

Lecture 19 Data Integrity Breach Part 3

Lecture 20 Data Integrity Breach Part 4

Lecture 21 Factors Leading to Data Integrity Issues

Lecture 22 Ways to Minimize Data Integrity Risk

Lecture 23 Role of Management Related To Data Integrity

Lecture 24 Role of Staff Members Related To Data Integrity

Lecture 25 Data Integrity-Do's

Lecture 26 Data Integrity-Don'ts

Lecture 27 Audit New Approach and Lesson

Lecture 28 Today’s Necessity

Lecture 29 Personnel Integrity and Ethics

Lecture 30 Advantages And Disadvantages of Data Integrity

Section 3: Multiple Choice Questions (MCQs)

Section 4: Final Words

Lecture 31 Meeting etiquettes Part 1

Lecture 32 Meeting etiquettes Part 2

Lecture 33 Congratulations, Thank you, Certification, Celebration!

Professionals Working In Pharmaceutical or Allied Industries (Department/Field-Regulatory Affairs, Quality Assurance, Quality Control, Formulation And Analytical Development, Pharmaceutical Data Management, etc.),Individuals Responsible For Ensuring Data Integrity And Regulatory Compliance In The Pharmaceutical Industry,Pharma Entrepreneurs And Consultants Involved In Pharmaceutical Industry Activities,Students And Faculty Members of Pharmacy, PharmD, Medical And Science Disciplines,Individuals Seeking A Career In The Pharmaceutical Industry With A Focus On Data Integrity And Regulatory Compliance