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11747 Professional Development courses delivered Online

PMP® Certification Training

0.0(2)

By Vnnergy LLC

Earn 35 PDUs or contact hours toward your Project Management education for certification with PMI®. Become PMP® certified today!

PMP® Certification Training
Delivered OnlineFlexible Dates
£499

Safer Recruitment Training

4.7(160)

By Janets

Safer Recruitment Training
Delivered Online On Demand3 hours 37 minutes
£25

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

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

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

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