How to audit GMP systems
What you'll 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
- Have basic GMP (Good Manufacturing Practices) or ISO 9001 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!
Who this course is for:
- 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
Mi nombre es Rubén Alonso, soy auditor de calidad de una multinacional farmacéutica desde hace 6 años. Estudié Farmacia en la universidad de Barcelona y realicé un Máster en Industria Farmacéutica seguidamente.
A parte de realizar auditorias a nuestros proveedores, también me encargo de dar formaciones a nuestro personal sobre auditorias y conceptos en GMP.
My name is Rubén Alonso, I am Quality Assurance Auditor working for a multinational pharmaceutical company. I studied Pharmacy at the University of Barcelona and afterwards, a Master degree in Pharmaceutical Industry.
Apart from auditing our suppliers, I am also in charge of training our staff on audits and concepts in GMP.