Post Graduate Diploma in Advanced Pharmaceutical Manufacturing (Post Graduate Diploma in Advanced Pharmaceutical Manufacturing)

Institute of Technology, Carlow (TBC)
Key Programme Details
Award

Post graduate Diploma

NFQ Level

Level 9 About NFQ

Delivery Method

Classroom

Mode

Full Time

ECTS Credits

60

Department

Faculty of Science

General Information
Contact

David Phelan

Email

david.phelan@itcarlow.ie

Phone

0599175557

Address

Faculty of Science
Institute of Technology
Kilkenny Road
Carlow

Role

Course Director

Important Dates
Application Deadline

27/11/2020

Start Date

11/01/2021

End Date

10/12/2021

About this Course

This course aims to provide an overview of the related disciplines that interact in the Pharma business sector. These disciplines broadly are quality assurance, regulations and regulatory control, validation, process and method development and finally operations. There is a life cycle to products and processes, as well as the constantly changing requirement of cGMP and introduction of new equipment and techniques. The course will cover all the disciplines working on pharma processes.The science behind advanced spectroscopy and the methods needed to validate advanced spectroscopic analysis such as data base management calibration tool boxes and how process analytical technology (PAT) methods are validated and managed compared to more traditional analytical procedures will be delivered in a combination of lectures and practical classes which will illustrate the theory and practical constraints of spectroscopy and sample analysis.The quality assurance and regulatory hurdles required to file and manage both traditional processes and advanced PAT analytical processes are defined and the processes are described in detail. The requirements for processes and methods to be fully approved for use and implemented in the pharma sector are put into context of the various disciplines involved. The perspective will be from a quality and regulatory discipline. The classes will be delivered so as individuals operating or developing these system have a complete understanding of the Regulatory requirements they need to meet. Classes will be theory based comprising the regulations quality assurance needs of the pharma/medical device sector. Finally the validation process for traditional processes and methods will be compared to advanced spectroscopic techniques and design spaces required for ICH Q8.

Objectives

This course aims to provide an overview of the related disciplines that interact in the Pharma business sector. These disciplines broadly are quality assurance, regulations and regulatory control, validation, process and method development and finally operations. There is a life cycle to products and processes, as well as the constantly changing requirement of cGMP and introduction of new equipment and techniques. The course will cover all the disciplines working on pharma processes.

Entry Requirements

Applicants for this Postgraduate Diploma Programme must normally have a first or second class Level 8 honours degree (NFQ or other internationally recognised equivalent) in a science, engineering or other relevant subject(s). In certain cases a blend of qualifications, motivation and relevant experience will be acceptable. Applicants applying for entry through progression routes other than those listed above will be considered on a case by case basis using equivalent prior learning that is recognised by IT Carlow as meeting this requirement in line with the Institute RPL policy.

Long Description

This course aims to provide an overview of the related disciplines that interact in the Pharma business sector. These disciplines broadly are quality assurance, regulations and regulatory control, validation, process and method development and finally operations. There is a life cycle to products and processes, as well as the constantly changing requirement of cGMP and introduction of new equipment and techniques. The course will cover all the disciplines working on pharma processes.The science behind advanced spectroscopy and the methods needed to validate advanced spectroscopic analysis such as data base management calibration tool boxes and how process analytical technology (PAT) methods are validated and managed compared to more traditional analytical procedures will be delivered in a combination of lectures and practical classes which will illustrate the theory and practical constraints of spectroscopy and sample analysis.The quality assurance and regulatory hurdles required to file and manage both traditional processes and advanced PAT analytical processes are defined and the processes are described in detail. The requirements for processes and methods to be fully approved for use and implemented in the pharma sector are put into context of the various disciplines involved. The perspective will be from a quality and regulatory discipline. The classes will be delivered so as individuals operating or developing these system have a complete understanding of the Regulatory requirements they need to meet. Classes will be theory based comprising the regulations quality assurance needs of the pharma/medical device sector. Finally the validation process for traditional processes and methods will be compared to advanced spectroscopic techniques and design spaces required for ICH Q8.

Timetable Info

Approximately 14 Hours per week

Delivery Notes

Blended

Admissions Contact Details
Contact Person

Caroline Whittle

Address

Admissions Dept
Institute of Technology
Kilkenny Road
Carlow

Phone

0597175174

Email

graduatestudies@itcarlow.ie