PIC/S GMP Sterile

Description

Online GMP training for PIC/S GMP

These courses are excellent for those wishing to meet the requirements of regulatory authorities that adhere to the PIC/S GMP standards. We offer over 20 different eLearning modules, covering basic PIC/S GMP requirements, including each of the PIC/S Annexes.

Associated Courses

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

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PIC/S GMP sterile manufacturing bundle

This bundle includes all GMP courses relating to the manufacture of sterile final dosage medical products for a PIC/S regulated company.

It includes the following modules:

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Module 1: Good Manufacturing Practice 01

This interactive eLearning 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

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Module 2: 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

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Module 3: Annex 1 – Manufacture of Sterile Medicinal Products

This interactive e-learning module introduces the specific GMP regulations for the manufacture of sterile medicines as found in Annex 1. 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

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Module 4: 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.

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Certification

After successful completion of each course in the bundle, the trainee will have the option of printing or saving a personalised training Certificate of Completion that meets regulatory GMP requirements.

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For the full list of participating authorities please refer to the PIC/S website at www.picscheme.org.

• Australian Therapeutic Goods Administration (TGA)
• Malaysian National Pharmaceutical Control Bureau (NPCB)
• Singapore’s Health Sciences Authority (HSA)
• South African Medicines Control Council (MCC)
• U.S. Food and Drug Administration (US FDA)
• Canadian Health Products and Food Branch Inspectorate (HPFBI)
• New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe)United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)
• United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)