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329 Courses

SUB05: Electronic Common Technical Document (eCTD)

By Zenosis

The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

SUB05: Electronic Common Technical Document (eCTD)
Delivered Online On Demand2 hours 30 minutes
£126

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

VAL04: Operational and Performance Qualification

By Zenosis

Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ 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.

VAL04: Operational and Performance Qualification
Delivered Online On Demand1 hour
£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

VAL05: Equipment Cleaning Validation

By Zenosis

Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning programme. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program for a new production line.

VAL05: Equipment Cleaning Validation
Delivered Online On Demand1 hour 30 minutes
£99

SUB15: The Biologics License Application (BLA) for Marketing Approval in the USA

By Zenosis

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

SUB15: The Biologics License Application (BLA) for Marketing Approval in the USA
Delivered Online On Demand3 hours 30 minutes
£99

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA

By Zenosis

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
Delivered Online On Demand30 minutes
£99

VAL06: Computer Systems Validation, Part 1: Planning

By Zenosis

In the medicines and healthcare products industries, computerised systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.

VAL06: Computer Systems Validation, Part 1: Planning
Delivered Online On Demand1 hour
£99

VAL07: Computer Systems Validation, Part 2: Implementation

By Zenosis

This module describes the design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerised systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company's project to validate a new dispensary control system.

VAL07: Computer Systems Validation, Part 2: Implementation
Delivered Online On Demand1 hour
£99