How to carry out a good risk analysis? Beyond FMECA

A good risk analysis provides a better understanding of the company’s internal operations, enabling the company to take better decisions when controlling potential risks. The aim is to increase the result reliability on each production process.

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GMP regulations must be applied when managing risk, which could imply “more paper”. Do we want to have more “risk analysis” paper files, or do we want them to become a tool to prevent problems in the production operations, and specifically, in inspections?

Risk analysis is usually understood as a new requirement that we should add to the list we already had (e.g., qualifications and validations), to be able to pass the inspections. However, this understanding is inaccurate, as risk analysis is a new approach to apply GMP. In other words, we are not increasing our tasks, but doing them following a different philosophy, according to which, we should know the risk involved, in order to meet the quality our processes and products must have.

September 2022
Duration 6h
Price
$229
Schedule
Saturdays from 9:00h am to 11:00h am (UTC-5)
Practical approach
Based on real cases
100% online
Live sessions

Benefits of attending the Risk Analysis course

Learning to analyze the problem adequately to determine the best solution

Establishing and defining priorities at the workplace

Developing own risk analysis methodologies based on real data

(Discarding the idea of using FMECA in any situation)

Taking advantage of all the benefits good risk analysis offers

Master the Risk Analysis philosophy and methodology to be able to apply it to GMP

Based on risk analysis allows you to improve your resources by using the risk systems and different tools to evaluate and reduce risks or risk impact, assuring quality in the complete process and medicaments. Contact us by Whatsapp for further information.

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Course objective

At the end of this course, you will be able to develop the necessary skills to use the Risk Analysis method appropriately

  • Know the benefits of doing a good Risk Analysis
  • Develop new techniques to face problems that arise
  • Know the different Risk Analysis methodologies, beyond FMECA
  • Take advantage of the information in ICH Q9 Guidelines

Who is this course aimed to?

This course is suitable for both students and active professionals in the pharmaceutical, cosmetics, and biomedical sectors

  • Quality control managers
  • Operation and manufacturing managers
  • Qualification and validation managers
  • Engineering and automation staff

Assessment and diploma

September - 6h

At the end of this course, you will need to pass a test to obtain the diploma of completion.
The training will be held during three consecutive Saturdays, in 2-hour sessions.

  • The attendees will need a computer or any other suitable device, with good Internet connection
  • La documentación del curso será entregada al finalizar el mismo.
Info and registrations