Certificate Course in Pharmaceutical Data Integrity

Focused View

Dr. Sachin Potawale

2:36:30

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1 - Data IntegrityIntroduction

1 - IntroductionBasic Understanding of Data Integrity.mp4

03:56

1 - List-Of-Data-Generated-In-The-Pharma-Industry.pdf

2 - Historical background of US Drug Law and Regulations.mp4

04:53

2 - Historical-background-of-US-Drug-Law-and-Regulations.pdf

3 - Drug Approval Process.mp4

04:17

3 - Drug-Approval-Process.pdf

4 - Good Manufacturing PracticesIntroduction.mp4

06:28

5 - Good Manufacturing PracticesGMP Principles.mp4

04:52

6 - GMP Vs cGMP.mp4

03:20

6 - GMP-1.pdf

6 - GMP-Data.pdf

6 - GMP-Principles.pdf

6 - GMP-Vs-cGMP.pdf

2 - Data IntegrityDeep Dive In To The Topic

7 - Data Integrity and Regulatory Requirements.mp4

02:12

7 - Data-Integrity-and-Regulatory-Requirements.pdf

8 - Importance of Data Integrity.mp4

03:57

8 - Importance-of-Data-Integrity.pdf

9 - Important Terminologies Related to Data Integrity Part 1.mp4

09:28

9 - Important-Terminologies-Related-to-Data-Integrity.pdf

10 - Important Terminologies Related to Data Integrity Part 2.mp4

06:26

11 - Important Terminologies Related to Data Integrity Part 3.mp4

08:23

12 - ALCOA ALCOA ALCOA Part 1.mp4

08:58

12 - ALCOA-ALCOA-ALCOA.pdf

13 - ALCOA ALCOA ALCOA Part 2.mp4

04:12

14 - ALCOA ALCOA ALCOA Part 3.mp4

04:34

15 - Types of Data Integrity Part 1.mp4

05:15

15 - Types-of-Data-Integrity-1.pdf

16 - Types of Data Integrity Part 2.mp4

03:32

17 - Data Integrity Breach Part 1.mp4

05:11

17 - Data-Integrity-Breach.pdf

18 - Data Integrity Breach Part 2.mp4

02:14

18 - Data-Integrity-Breach-1.pdf

18 - Data-Integrity-Breach-2.pdf

19 - Data Integrity Breach Part 3.mp4

04:40

19 - Data-Integrity-Breach-1.pdf

19 - Data-Integrity-Breach-2.pdf

20 - Data Integrity Breach Part 4.mp4

01:19

21 - Factors Leading to Data Integrity Issues.mp4

06:33

21 - Factors-Leading-to-Data-Integrity-Issues.pdf

22 - Ways to Minimize Data Integrity Risk.mp4

08:19

23 - Role of Management Related To Data Integrity.mp4

06:43

24 - Role of Staff Members Related To Data Integrity.mp4

04:06

25 - Data IntegrityDos.mp4

02:45

26 - Data IntegrityDonts.mp4

03:23

27 - Audit New Approach and Lesson.mp4

06:13

27 - Audit-New-Approach-and-Lesson.pdf

28 - Todays Necessity.mp4

03:01

28 - Today-s-Necessity.pdf

29 - Personnel Integrity and Ethics.mp4

04:30

30 - Advantages And Disadvantages of Data Integrity.mp4

05:49

3 - Multiple Choice Questions MCQs

4 - Final Words

31 - Meeting etiquettes Part 1.mp4

02:58

31 - Meeting-etiquettes-Part-1.pdf

32 - Meeting etiquettes Part 2.mp4

01:46

32 - Meeting-etiquettes-Part-2.pdf

33 - Common-Interview-Preparation-Tips.pdf

33 - Congratulations Thank you Certification Celebration.mp4

02:17

33 - DI-MCQ.pdf

33 - How to Download Your Certificate of Completion on a Browser.txt

33 - Important-Literature-Search-websites.pdf

33 - LinkedInDr Sachin Potawale.txt

33 - Link-Details.docx

33 - Regulatory-Authorities-Of-Various-Countries.pdf

33 - TwitterPharmasolvers Consultants LLPDr Sachin Potawale.txt

Description

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

Who is this for?

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

What You Need to Know?

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

More details

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:
â€¢ Basic Understanding of Data Integrity
â€¢ Data Integrity and Regulatory Requirements
â€¢ Importance of Data Integrity
â€¢ Important Terminologies Related to Data Integrity
â€¢ ALCOA, ALCOA+, ALCOA++
â€¢ Types of Data Integrity
â€¢ Data Integrity Breach
â€¢ Factors Leading to Data Integrity Issues
â€¢ Summary of Data Integrity Issues
â€¢ Ways to Minimize Data Integrity Risk
â€¢ Role of Management Related To Data Integrity
â€¢ Role of Staff Members Related To Data Integrity
â€¢ Data Integrity-Do's And Don'ts
â€¢ Audit New Approach and Lesson
â€¢ Personnel Integrity and Ethics
â€¢ Advantages And Disadvantages of Data Integrity
â€¢ Many more
There 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.
Who this course is for:
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

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Data Science

Pharmaceutical Industry

Dr. Sachin Potawale

Instructor's Courses

• Director of Pharmasolvers Consultants LLP, Pune, Maharashtra, India.• Ph.D. awarded in the subject of Pharmaceutical Chemistry, under the Faculty of Pharmaceutical Sciences from Bharati Vidyapeeth Deemed University (Poona College of Pharmacy, Erandwane, Pune-411038, India). Master of Pharmacy (Double Post-graduation)-Pharmaceutical Chemistry (Savitribai Phule Pune University) and Pharmacognosy (Bharati Vidyapeeth Deemed University).• Well-versed with the concepts of Drug Regulatory Affairs, Clinical Research, Pharmacovigilance, Medical/Scientific writing, Regulatory guidelines, Development Quality Assurance (DQA), ISO 9001:2015 Quality Management System Auditor, QMS Lead Auditor, Computer System Validation (CSV), Analytical Method Development, Validation, Pearson Test of English Academic (PTE Academic), Lean Management, Six Sigma, Leadership, Time Management, Training of Professionals.•An effective communicator with honed interpersonal, analytical, problem-solving, and motivational skills.•Published several Research articles (International-24, National- 06), Review articles (International- 10), and a book.

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