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Updated in [September 26th, 2023]

What does this course tell?
(Please note that the following overview content is from the original platform)
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 systemsWhat 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 auditsMoreover, 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 investmentSo, at the end of this course you will have the knowledge to perform audits to GMP suppliers.See you on the course!

We considered the value of this course from many aspects, and finally summarized it for you from two aspects: skills and knowledge, and the people who benefit from it:
(Please note that our content is optimized through artificial intelligence tools and carefully reviewed by our editorial staff.)
What skills and knowledge will you acquire during this course?By enrolling in the course "How to audit GMP systems," you will acquire the following skills and knowledge:
1. General information: You will gain an understanding of the history of Good Manufacturing Practices (GMP), regulatory requirements, and different types of audits.
2. Risk-based approach: You will learn how to identify and prioritize which areas or suppliers should be audited based on their level of risk.
3. Audit process: You will be familiarized with the step-by-step process of conducting an audit, including planning, execution, and reporting.
4. Audit plan and audit team: You will learn how to develop an effective audit plan and assemble a competent audit team.
5. Auditor skills and technical knowledge requirements: You will understand the essential skills and knowledge that auditors should possess to effectively assess GMP systems.
6. Categorization of audit findings: You will learn how to categorize and evaluate audit findings based on their severity and impact on GMP compliance.
7. Auditing API suppliers: You will gain insights into auditing suppliers of Active Pharmaceutical Ingredients (APIs) and the specific considerations involved in this process.
8. Handling different behaviors from auditees: You will learn strategies for dealing with various behaviors and attitudes exhibited by auditees during the audit process.
9. Other related topics: The course will cover additional relevant topics, such as remote audits and provide examples and supportive documentation to enhance your understanding.
Upon enrolling in the course, you will receive the following benefits:
- Lifetime access to the course and future updates, allowing you to revisit the material whenever needed.
- Personalized support and answers to all your questions and doubts, ensuring a comprehensive learning experience.
- A certificate in "How to audit GMP suppliers" from Udemy, which can be included on your resume to showcase your expertise in auditing GMP systems.
- A money-back guarantee within the first 30 days, providing a risk-free investment opportunity.
By the end of this course, you will have the knowledge and skills necessary to effectively perform audits of GMP suppliers.

Who will benefit from this course?
This course on how to audit GMP systems will benefit professionals in the pharmaceutical industry, particularly those involved in quality assurance and quality control. It is also relevant for auditors who are responsible for ensuring compliance with Good Manufacturing Practices (GMP) in pharmaceutical companies and their suppliers.

Specific professions that will benefit from this course include:

1. Quality Assurance Managers: They will gain a detailed understanding of the audit process and the skills required to effectively audit GMP systems. This knowledge will enable them to ensure that their company's quality systems are in compliance with regulatory requirements.

2. Quality Control Managers: They will learn how to assess the quality of pharmaceutical raw materials supplied by external vendors through audits. This will help them in making informed decisions about the suitability of suppliers and the quality of the final medicinal product.

3. Auditors: This course will provide auditors with the necessary knowledge and skills to conduct audits of GMP systems. They will learn about the different types of audits, how to plan and execute audits, and how to categorize audit findings. This will enhance their ability to identify non-compliance issues and recommend corrective actions.

4. Pharmaceutical Raw Material Suppliers: Suppliers will benefit from this course as it will help them understand the expectations and requirements of auditors. They will learn how to prepare for audits and how to address any findings or concerns raised during the audit process.

Course Syllabus

Presentation

Introducción

Who should be audited?

The audit process

Auditor behavior and techniques

Auditing API suppliers

Different behaviors in the Audit room

Other topics