WHO GPM Evolution: Sterile pharmaceutical products



Part 1 - Quality management: philosophy and essential elements.
Part 2 - Good practices in production and quality control.
Part 3- Sterile pharmaceutical products.

salas-blancas-esteriles

In this course we will analyze the changes in the GMP fundamental principal guidelines, published by WHO in 2011 (Report 45, TRS nº 961, Annex 3), regarding the former version from 2003 (Report 37, TRS nº 908, Annex 4)./b>.

In 1992, some WHO general GMP were published in Report 32, structured in three parts. By including risk management in the pharmaceutical production in the early XXI century, the need to apply extreme precautions to the sterile production, became evident due to the significant risk of contamination (with severe consequences for patients), as well as to the difficulty to detect them. All this led to its publication in a separate report dedicated to the sterile products primarily in contamination risk management. .

July 2022
Duration 4h
Price
$155
Schedule
Saturdays from 9:00h am a 11:00h am (UTC-5)
Practical approach
Based on real cases
100% Online
Live sessions

GMP regulatory changes included in this course

  1. Emphasis and detail on cleanroom supervision

  2. Revision of the cleanroom classification and their requirements

  3. The need to reproduce the process through “media fillis” cultures

  4. The definition of the precautions considered in the sterilization processes. New technologies are considered (insulator and “blow-fill-seal”).

  5. Focus on the need to properly control the containers until they are completely closed.

Do you want to know more?

Contact us via WhatsApp

Chat now

Objective

To become updated in terms of the regulations, assess the changes, and learn how to adapt to comply with the GMP regulations.

Who is this course aimed to?

This course is perfect for both students and professionals from the pharmaceutical or biomedical industries.

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

Evaluación y diploma

Julio - 4 horas

At the end of this course, you will need to pass a test to obtain the diploma of completion. In case of wrong answers, you will receive feedback.
Once the course is completed successfully, all the modules presentations together with the diplomas will be sent by email.

  • The attendees will need a computer or any other suitable device, with good Internet connection.
  • The course documentation will be provided at the end of the course
Registration and information