How to Implement Quality by Design

Online Training Id: PQMS-003

Geographical Region: All

Level: Intermediate

Duration: 3 hrs 

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The application of the Principals of Quality by Design will built QUALITY into a product from an understanding of the product and process and knowledge of the Critical to Quality attributes and Critical Process parameters involved in manufacturing the product to achieve the optimum Quality Target Product Profile.

The lecture will review the systemic, knowledge and risk based quality methodology used to ensure the consistency of product, and will provide a case study in which to demonstrate the application of the Quality By design principals, and will provide an assessors view of the measures proposed in the lecture “Regulatory Assessment requirements of Quality by Design data”.

Learning Objectives:

This course will provide the key steps used in Quality by Design , and which will include the development of the API manufacturing process, Formulation of the Drug product and standards for batch release, the essential part of the process is to assure the control of quality by qualifying the following controlling factors for the product;

  • Quality Target Product Profile (QTPP)

  • Critical Quality Attributes (CQA)

  • Critical Process Parameters (CPP)

  • Design Space (DS)

  • Control Strategy

  • Process Analytical Technology (PAT)

Who Should Enroll:

All Staff involved in Pharmaceutical Processes –Product Registration, Product Development, Clinical assessment, Manufacturing , Distribution, and Pharmacovigilance

Author:

 

 

 

 

 

 

 

 

 

John DR Jolley - FR Pharm S, FCQI CQP is a co-founder of Pharma Consult Global, a Pharmaceutical Consultancy providing technical consultancy and training European countries, Middle East, South Africa and the USA and involving International Pharmaceutical Experts from around the world.  He is a pharmacist who has held positions in Clinical Research, Product Registration, Pharmaceutical Manufacturing, Quality Assurance, and General Management.  He was Technical Director for Boehringer Ingelheim UK for 15 years before working in Technical consultancy. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations, and  is  an  Industry  representative  on  the  EMA  advisory  committees  for GMP/GCP.  John  has  a  degree  in  Pharmacy  and  has  been  awarded  fellowships  with  the  Royal Pharmaceutical Society and the Chartered Quality Institute.

John Dr Jolley  FR PHARM S, FCQI CQP

GBP $120.00

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