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.