How to audit GMP systems

How to audit GMP systems, available at $54.99, has an average rating of 4.05, with 21 lectures, based on 124 reviews, and has 547 subscribers.

You will learn about General information on audits Which types of suppliers should be audited The audit process, how to plan and conduct audits efficiently Auditor behaviors and techniques, to face the various challenges How to audit API manufacturers Other interesting related topics This course is ideal for individuals who are Current pharmaceutical industry employees or Employees from companies supplying products to pharmaceutical companies or People interested in entering the world of the pharmaceutical industry which would like to have a deeper knowledge It is particularly useful for Current pharmaceutical industry employees or Employees from companies supplying products to pharmaceutical companies or People interested in entering the world of the pharmaceutical industry which would like to have a deeper knowledge.

Enroll now: How to audit GMP systems

Summary

Title: How to audit GMP systems

Price: $54.99

Average Rating: 4.05

Number of Lectures: 21

Number of Published Lectures: 21

Number of Curriculum Items: 21

Number of Published Curriculum Objects: 21

Original Price: €29.99

Quality Status: approved

Status: Live

What You Will Learn

General information on audits
Which types of suppliers should be audited
The audit process, how to plan and conduct audits efficiently
Auditor behaviors and techniques, to face the various challenges
How to audit API manufacturers
Other interesting related topics

Who Should Attend

Current pharmaceutical industry employees
Employees from companies supplying products to pharmaceutical companies
People interested in entering the world of the pharmaceutical industry which would like to have a deeper knowledge

Target Audiences

Current pharmaceutical industry employees
Employees from companies supplying products to pharmaceutical companies
People interested in entering the world of the pharmaceutical industry which would like to have a deeper knowledge

Audits is one of the best tools to learn and understand the process and the quality system of any company. For this reason, internal audits to your company and audits to the pharmaceutical raw material suppliers are usually performed to ensure the quality of the supplied product and therefore to ensure the quality of the final medicinal product.

Initial and continuous professional training for auditors is of utmost importance for the correct performance and take advantage of the audits. Therefore, I have developed this course to give you a detailed overview about important matters to consider and to be aware when performing audits to GMP systems

What you will learn:

· General information (GMP history, Regulatory requirements, audit types, etc)

· Who should be audited, risk-based approach

· Audit process

· Audit plan and audit team

· Auditor skills and technical knowledge requirements

· Categorisation of audit findings

· Auditing API suppliers

· Different behaviors from the auditees and how to handle them

· Other related topics as remote audits

Moreover, during the course I will handle many examples and supportive documentation for your knowledge.

What will you receive when enrolling into the course?

· Lifetime access to the course and future updates

· Personalized support and answer to all your questions and doubts

· Certificate in “How to audit GMP suppliers” from Udemy – which you can include on your resume

· Money-back guarantee in the first 30 days – if you don’t like the course you can request a 100% refund of your investment

So, at the end of this course you will have the knowledge to perform audits to GMP suppliers.

See you on the course!

Course Curriculum

Chapter 1: Presentation

Lecture 1: Presentation

Chapter 2: Introducción

Lecture 1: Introduction Part 1

Lecture 2: Introduction Part 2

Lecture 3: Introduction Part 3

Chapter 3: Who should be audited?

Lecture 1: Who should be audited?

Chapter 4: The audit process

Lecture 1: Preparation of the audit and audit process

Lecture 2: Post audit activities and summary

Chapter 5: Auditor behavior and techniques

Lecture 1: Auditor behavior and Techniques 1 part

Lecture 2: Auditor behavior and Techniques 2 part

Chapter 6: Auditing API suppliers

Lecture 1: Warehouse

Lecture 2: Production

Lecture 3: Quality control laboratory

Lecture 4: Quality control / Microbiological laboratory

Lecture 5: Documentation and records review 1

Lecture 6: Documentation and records review 2

Lecture 7: Documentation and records review 3

Lecture 8: Documentation and records review 4

Chapter 7: Different behaviors in the Audit room

Lecture 1: Part 1

Lecture 2: Part 2

Chapter 8: Other topics

Lecture 1: Remote auditing 1

Lecture 2: Remote auditing 2

Instructors

Ruben Alonso
Auditor de Calidad en Industria Farmacéutica

Rating Distribution

1 stars: 1 votes
2 stars: 1 votes
3 stars: 19 votes
4 stars: 48 votes
5 stars: 55 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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