Non Sterile Final Dosage

Description

Online GMP training Non Sterile Final Dosage  

Course Description 

This course introduces the general principles and purpose of Good Manufacturing Practice for the manufacture of medicinal products in a non-sterile final dosage form.

Which GMP compliance courses are included in this bundle?

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

• Good Manufacturing Practice 01
• The 10 Golden Rules of GMP
• Good Record Keeping
• Annex 09 – Manufacture of Liquids, Creams and Ointments

Who should complete this Bundle?

This entry-level bundle is ideal for all production and quality personnel involved in the manufacture of 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, logbooks 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 09 – Manufacture of Liquids, Creams and Ointments

The manufacture of liquids, creams and ointments must be performed in accordance with the practices described in the PIC/s Guide to GMP where applicable. This training module is intended to provide an understanding of the specific requirements outlined in Annex 9 relating to equipment, environmental considerations and production requirements for manufacture of liquids, creams and ointments.

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.

The bundle price is per person and includes 12 months of access to these three core modules. Additional modules covering other applicable Annexes can be added to this course as required.