Last updated 6/2021
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 8.22 GB | Duration: 12h 0m
This course will take you to understand about how product is designed, product transfer & validation aspects
What you'll learn
This course will help students to learn about pharmaceutical products, development, keys in potent product manufacturing, technology transfer, analytial and manufacturing process validation and stability study requirements. This course will help students to learn product design concept and manufacturing with life cycle approach.
Requirements
The person who is interested in learning should learn in focussed way to understand the concepts and practical approach.
Description
This course will take you to understand about how product is designed, product transfer & validation aspects before commercialisation. After commercialisation further it will focus on how stability study is performed.First of all, we need to learn about product development as per the ICH guideline - ICH Q8. This will explain us about how to design the pharmaceutical products and also how quality by design concept to be followed. After this, main step is about technology transfer in the pharmaceuticals. This technology transfer will focus on transfer of analytial technology as well as manufacturing process technology in the manufacturing unit. Once technology is transferred, the first commerical batches manufactured should be studied in detailed as per the process validation requirements. Furthermore, it is important to note that, there is special care to be taken in case of manufacturing of potent molecules. So, a separate lecture on manufacturing of potent molecules is available in this course. This is still not enough for pharmaceutical products. After process validation, the process validation batches should be subjected for stability study. Furthermore, long term stability study will be continuted for every year. Overall this training session will be very much helpful for all pharmaceutical professionals for learning from design the product to commercialisation.
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 Pharmaceutical Product Development
Lecture 3 Analytical Method Validation Requirements
Lecture 4 Technology Transfer Requirements
Lecture 5 Equipment & Instrument Qualification Requirements
Lecture 6 Process Validation Requirements
Lecture 7 Potent Product Manufacturing in Pharma
******** students, Pharmaceutical professionals, consultants etc. This course is essential for auditors, quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers
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