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273 Courses

VAL03: Commissioning and Installation Qualification

By Zenosis

Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

VAL03: Commissioning and Installation Qualification
Delivered Online On Demand1 hour 30 minutes
£99

VAL02: Validation Plans and Documentation

By Zenosis

Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

VAL02: Validation Plans and Documentation
Delivered Online On Demand1 hour 30 minutes
£99

VAL01: Introduction to Validation

By Zenosis

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This module provides an introduction to validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

VAL01: Introduction to Validation
Delivered Online On Demand1 hour 30 minutes
£99

SUB06: Variations to Marketing Authorisations in Europe

By Zenosis

Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.

SUB06: Variations to Marketing Authorisations in Europe
Delivered Online On Demand3 hours 30 minutes
£99

ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products

By Zenosis

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Delivered Online On Demand3 hours
£99

SUB11: The Decentralised Procedure (DCP)

By Zenosis

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

SUB11: The Decentralised Procedure (DCP)
Delivered Online On Demand2 hours
£98

SUB03: The Mutual Recognition Procedure (MRP)

By Zenosis

his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

SUB03: The Mutual Recognition Procedure (MRP)
Delivered Online On Demand2 hours
£98

CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure

By Zenosis

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
Delivered Online On Demand2 hours
£98

SAM04: Marketing of Prescription Drugs in the USA – Interactions with Healthcare Professionals

By Zenosis

The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.

SAM04: Marketing of Prescription Drugs in the USA – Interactions with Healthcare Professionals
Delivered Online On Demand1 hour
£95

SAM02: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

By Zenosis

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

SAM02: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA
Delivered Online On Demand1 hour 30 minutes
£95