Approved training courses
Course Overview
The Qualified Person must understand the influence of manufacturing pathways and associated physical and physico chemical attributes of both active pharmaceutical ingredients and major excipients on the quality of the finished dosage form.
QP responsibilities also include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying with importation requirements as defined in the Falsified Medicines Directive. This course includes both the technical aspects of manufacturing APIs and the requirements of Good Manufacturing Practice.
This course includes the following topics:
Day 1
- Methods and equipment including virtual tour of chemical facilities
- Methods and equipment for Bio APIs
- GMP requirements for API’s-Eudralex Vol 4
- GMP requirements FMD and GDP
- GMP requirements ICH and impurities
Day 2
- Registration aspects including QP declaration exercise
- Laboratory controls
- Process validation overview
- Cleaning validation overview
- Supply chain and QP responsibilities
- The control of API packaging materials
- API audit situations
This is an essential course for all those who expect to be taking the QP Viva, it is also a valuable contribution to Continuing Professional Development for QPs who qualified some years ago. This is also suitable for those who require a
Online
2 days
£1390.00 GBP (plus VAT)
Find an approved training course
Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.
Courses are approved for CPD purposes only; approval does not imply they will fulfill any regulatory requirements.
