PIC/S GMP non-sterile

PIC/S GMP non-sterile

USD $80.00

Course duration: Allow approximately 4 to 6 hours to complete all 4 courses in this training bundle.

Description

Online GMP training for PIC/S GMP non-sterile

These courses are excellent for those wishing to meet the requirements of regulatory authorities that adhere to the PIC/S GMP standards.

Courses in this PIC/s (non-sterile) regulatory compliance training bundle:

The four courses in this training bundle are:

  • Good Manufacturing Practice o1
  • Good Record Keeping
  • The 10 Golden Rules of GMP
  • Annex 09 – Manufacture of Liquids, Creams and Ointments

PIC/S GMP non-sterile manufacturing training bundle

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

This training bundle includes the following modules –

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: 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 3: 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 4: Annex 9 Manufacture of Liquids, Creams, and Ointments

The manufacture of liquids, creams, and ointments must be done in accordance with the regulations described in the PIC/s Guide to GMP where applicable. This interactive eLearning module covers the specific GMP regulations relating to the manufacture of liquids, creams, and ointments for human use. This training module is intended to provide an understanding of the specific equipment and environmental considerations and production requirements for the 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 of Completion that meets regulatory GMP requirements.

Other GMP courses

We offer over 20 different eLearning modules, covering basic PIC/S GMP requirements, including each of the PIC/S Annexes.

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)