Sterile Final Dosage

Sterile Final Dosage

$80.00

This course bundle includes the four modules essential to understanding the basics of Good Manufacturing Practice (GMP) within a sterile final dosage form facility:

  • Good Manufacturing Practice 01
  • The 10 Golden Rules of GMP
  • Good Record Keeping
  • Annex 01 – Manufacture of Sterile Medicinal Products

 

 

 

Description

Online GMP Training Sterile Final Dosage – Bundle 

Course Description 

This course introduces the general principles and purpose of Good Manufacturing Practice and the specific GMP regulations for the manufacture of  sterile medicinal products.

Who should complete this Bundle?

This entry level bundle is ideal for all production and quality personnel involved in the manufacture of sterile medicinal products.  This course is suitable for use as an induction for new starters or as refresher training for experienced staff.

Module Descriptions:

Module 1: Good Manufacturing Practice 01

This interactive e-Learn provides an introduction to the basic principles of Good Manufacturing Practice. It is suitable for all personnel who work within a GMP regulated environment.

The objectives of the Good Manufacturing Practice module are:

  • to understand the basic purpose, elements, and implementation of GMP
  • to understand the intent and scope of GMP
  • to understand who enforces GMP regulations and the importance of GMP
  • to understand the basics of GMP, correcting errors, date formats, hygiene, etc

Module 2: The 10 Golden Rules of GMP

This interactive e-Learn provides a straightforward guide to cGMP in the form of the 10 golden rules. Keep these easy-to-remember rules in mind when making GMP decisions.

Module 3: Good Record Keeping 01

This e-learning module introduces participants to Good Record Keeping Practice. This module is essential for all personnel who complete or review batch records, log books and any other GMP documentation.

The objectives of the Good Record Keeping module are:

  • to understand why record keeping is so important
  • to understand how to delete or strike out errors
  • to understand what you should do when creating records
  • to understand what you should not do when creating records

Module 4: Annex 1 Manufacture of Sterile Medicinal Products

This interactive e-learning module introduces the specific GMP regulations for the manufacture of sterile medicines. This module is essential for personnel who work within the areas of final fill and finish, environmental monitoring or sterility assurance.

The objectives of this training module are:

  • to understand the principles of sterile manufacturing
  • to understand the types of sterile manufacturing
  • to understand cleanroom classification and monitoring
  • to understand personnel requirements including garments
  • to understand the requirements for sterile manufacturing premises
  • to understand the importance of sanitation
  • to understand different sterilisation methods
  • to understand the importance of Quality Control

The regulations outlined in this module do not apply to non-sterile manufacturing facilities, however it is possible to draw valuable good practice guidance for non-sterile facilities.

Certification

After successful completion of each course in the bundle the trainee will have the option of printing or saving a personalised training certificate that meet general PIC/S and EU GMP regulatory expectations.

Bundle price is per person and includes 12 months access to the four modules.

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