Become a Pharma Industry Audit Leader

person icon Zahra Hassan Sobhy

Become a Pharma Industry Audit Leader

Be qualified pharma industry audit leader, professional audit leader, master any site auditing.

updated on icon Updated on Sep, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Science,Teaching & Academics,Internal Audit


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Course Description

This course will provide you with all the tools that you will need to become a professional pharma industry audit leader.

If you would consider the prestigious highly successful career of auditing either within your organization, or if you are willing to start your career with, or if you want to consider the career of auditing for your own business, like most of the pharma industry professionals do these days to fulfill the modern business model requirements of outsourcing, as the cat as external audit leaders, so in all cases, you are in the right place to kick off your successful career in the pharma industry as an audit leader.

Auditing is an evaluation  of a person, organization, system, process, enterprise, project, or product

Could be, financial, project management, quality management (Compliance), vigilance (Safety),  regulatory, investigation, and finally trend analysis. focusing on the quality management audit, the kind of audit of great concern by most of the health authorities all over the world, followed by recently by the vigilance audit.

In this course we will cover everything about auditing, starting from definition and why we do need auditing, different types of audits, such as first Party (Internal), second Party (Supplier), third Party (External), and then who should participate in the audits? only auditors? or auditors and some professionals? who would be responsible for managing the audit, leading the audit, and finally closing the audit and wring the audit report? we will answer all these questions together along with our course.

Then we will explore together, what are the most common objectives of auditing? how to set these objectives and what is the set scope of such an audit? how to plan for an audit? how to manage an audit? to set an audit program and perform it? what are audit principles and approaches, prepare an audit checklist, how an audit workflow looks like, and finally how to conduct an audit?

After auditing, do we have 2  probabilities of such an audit? if complied or not? what if nonconformities are reported as audit findings? how to manage these nonconformities? and how this is related to the ISO, and ICH Q10 Pharmaceutical Quality System (PQS)

From here it comes to the CAPA, the topic which has been mentioned in most of the pharma industry courses, we will go deeper into the CAPA, starting from why do we need CAPA and when? Who should raise the CAPA? the CAPA phases, monitoring, CAPA SOPs till coming up with the final CAPA report.

We will focus on common confusing terms of CAPA

we will differentiate among correction, corrective action, and preventive actions in the pharma industry

and will close the topic of CAPA by the automated CAPA through CAPA software.

The most important part ever of this course is the part titled

"What makes a good auditor?

In another word, what qualify you to become an audit leader? how to become a professional audit leader?

To kick off your career then

So let us start our journey toward auditing, my dear future audit leaders.

Who this course is for:

  • Pharma industry professionals, beginners and fresh graduated who area enthusiastic to start their career in the pharma industry


What will you learn in this course:

  • In this course you will master the audits and will be qualified pharma industry audit leader

  • Pharma industry audit leader

  • Mastering pharma industry audits

  • Become qualified audit leader

  • Become a professional audit leader


What are the prerequisites for this course?

  • Laptop and willing to learn

Become a Pharma Industry Audit Leader


Check out the detailed breakdown of what’s inside the course

11 Lectures
  • play icon Introduction 03:49 03:49
  • play icon Audit 04:56 04:56
  • play icon What is an Audit? 14:11 14:11
  • play icon Quality Audit 10:24 10:24
  • play icon Audit Principles 14:54 14:54
  • play icon Audit Cheklist 03:13 03:13
  • play icon Conducting audit 09:31 09:31
  • play icon Non Conformities 05:08 05:08
  • play icon ICH 13:31 13:31
  • play icon CAPA 15:09 15:09
  • play icon Risk Assessment 15:09 15:09

Instructor Details

Zahra Hassan Sobhy

Zahra Hassan Sobhy

This is Zahra Hassan, I'm a pharmacist, with almost 10 years of experience in the pharma industry, my experience is extended to cover the regulatory affairs field, which deals with registration and granting health authorities approval for health products, including medicines, medical devices, over the counter products "OTC", such as food supplements, and cosmetics as well.

This is in addition to the quality compliance, control, and assurance for these health products, and also ensuring product safety through pharmacovigilance activities.

I have been practicing all these professions for 10 years covering 20 countries, across the regions of the Middle East, Africa, Levant, and Turkey.

During my career journey, I gave myself lots of credits by postgraduates studies

Msc of pharmacovigilance Bordeaux university France

MBA, Chiffley buisneiss school , Australia

Dual Diploma of regulatory affairs "pharmaceutical and medical devices" RAP society, USA.

Certified lead auditor

currently enrolled in the Ph.D. program of pharmacovigilance Bordeaux university France

Despite the fact that postgraduate studies for sure will add to the profile, but the practice is something else, in the begging of my career journey I was chasing professionals asking for private lessons after work to gain practical experience from them, and it was not for free, I used to make this deal with many professionals as I can to get as much diverse experience that I can gain, in addition, I used to follow national and international pharma industry events attending, then participating from my own pocket. This simply happens when you follow your passion.

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