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Online GMP training for Life Sciences and Pharma organisations

Failing to adhere to all the requirements of Good Manufacturing Practice (GMP) within a life sciences business can be catastrophic for all interested parties, patients, employees, and shareholders alike and include loss of life as well as punitive fines.

ART Providers has partnered with Zenosis to bring you the best GMP digital learning. Zenosis specialises in digital learning for regulatory and compliance needs in the medicinal and pharmaceutical products sector. Courses are updated regularly with up-to-date statistical data, and with vital changes to any industry, regulatory, governmental, or other factors and they feature high quality, interactive instructional design, expert content, and a comprehensive end-of-course knowledge-check and learner assessment.

ART Providers offers you a full range of GMP courses accredited with CPD points by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.

Introduction to GMP (GMP01)
All manufacturing personnel must receive initial and ongoing training in the theory and practice of GMP. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This module provides an ideal induction and refresher course in the basics of GMP. IT begins by explaining what GMP is and why it is necessary and then sets out its main principles. Finally, it focuses on two aspects of GMP that apply to everyone in the manufacturing environment: hygiene, cleaning, and sanitation; and documentation.

Good Documentation Practice (GMP02)
Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, maintenance, use, and retention of documents to provide assurance of the quality of products. This module emphasises the crucial importance of GDocP and identifies five principles that underpin it. It explains the functions of the various types of documents that are used and discusses how they should be created and controlled. Finally, it sets out requirements for record keeping – how data are to be entered into records, corrected if necessary, and how records must be retained.

GMP for Cleaning and Sanitation (GMP03)
Cleaning and sanitation of premises and equipment are essential to efforts to prevent contamination of product, and they need to be done in compliance with Good Manufacturing Practice (GMP) regulatory requirements. This module shows why it is so important to do a good job, what to consider before and during each job, and how best to go about the work. It begins by explaining how product may become contaminated and what can be done to prevent contamination through effective cleaning and sanitation procedures. It sets out good practices to keep the factory clean and sanitary, and describes how to prepare for and carry out cleaning and sanitation of premises. Finally it turns to the vitally important subject of cleaning and sanitising of production equipment.

GMP in the Warehouse (GMP04)

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them. It begins with an introduction to work in the warehouse of a medicinal products manufacturer, in which it describes the kinds of goods that come in and go out and how they may be stored in a typical layout. It identifies methods of segregating stock, and sets out seven main goals of GMP for the warehouse. GMP for the warehouse overlaps with Good Distribution Practice (GDP), which applies to the whole distribution chain for products. In the next session it discusses procedures for the receipt of inward goods and outline how the goods are checked, recorded and labelled, quarantined, sampled and tested, and released for use or rejected. In the third session, it describes good practice for storage, inventory control, and transfer of materials and products to and from production. Finally, it discusses dispatch of finished products, and procedures for dealing with returned or recalled products.

GMP and Processing Medicinal Products (GMP05)
Operations in the dispensary and on processing lines are at the heart of medicinal product manufacturing. This module describes how to carry out such operations in compliance with the requirements of Good Manufacturing Practice. It discusses how to: dispense starting materials; set up, control, and record formulation processes; evaluate product yield and calculate materials reconciliation. It sets out the Good Manufacturing Practice (GMP) requirements that must be met in carrying out these tasks.

GMP and Packaging Medicinal Products (GMP06)
Packaging operations constitute the last manufacturing step before release of a product to the market. They convert bulk product to the final product. Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. This module describes the functions that packaging must fulfil and the quality controls that are applied to packaging materials and operations. It sets out the requirements for control of printed materials. It then describes preparation, in-process control, and completion of a packaging run. Finally, it explains how to carry out reconciliation of packaging materials.

Corrective and Preventive Action (CAPA) (GMP07)
A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.

These online, self-paced courses offer you a cost-effective learning solution that can be accessed anytime and anywhere by your staff ensuring minimal disruption to operational duties. You can access the GMP courses via the ART Providers Life Sciences Learning Centre, or they can be hosted on your organisation’s SCORM 1.2 compliant Learning Management System or Learning Experience Platform.

 

Please contact us for evaluation access to any of our courses or for a quotation.