Pharmaceutical Quality Assurance - Ultimate Course (2023)

Market complaints, Hold time studies, Cleaning Validations, Recalls and Returns, Vendor Qualifications, CSV

What you'll learn

Various approvals required for running a pharma plant

Guidelines as per USFDA that are to be followed during the manufacturing and packaging

Types of Phaemaceutical industries

Various Quality assurance checks during manufacturing and packaging of the API and different formulations

Hold time studies concepts

Collection of various samples and the sampling accessories during the manufacturing and packing of the products and the importance of the reserve samples

Market complaints with examples and addressing them

Recall and return of the products from the market

Concepts of Validations

Concepts of Cleaning validation

Concepts of computer system validation

Concepts of Qualifications

Concepts of Vendor qualifications

Concepts of Annual product quality review

Batch release procedure in pharma industry

Requirements

Basic Knowledge on Pharmaceutical industry

Basic level of English

Good quality of internet connection, Desktop /Laptop/Smartphone required(Since dealing with online mode

Description

Quality assurance is one of the most important aspects of the entire drug manufacturing process. Not only will it help companies protect their reputations, but it will allow them to avoid hefty penalties from regulatory organizations.The purpose of pharmaceutical quality assurance is to ensure that the medication being manufactured will provide the desired effect to the patient. Quality assurance also guarantees that there are no contaminants present and that the medications will meet quality requirements and all relevant regulations.Syllabus covered:Class-1-Pharma industry in India–-Various approvals required for running a pharma plant.Class-2-Discussion on guidelines as per USFDA that are to be followed during the manufacturing and packaging.Class-3-Types of industry-a) API unitb) Formulation unit–- Oral solid forms                                    – Liquid orals                                    –Sterile formulations                                    – semisolids forms                                    –-BiologicsClass-4Discussion on various Quality assurance checks during manufacturing and packaging of the API and different formulations.Class-5Discussion on hold time studies conceptsClass-6Discussion on collection of various samples and the sampling accessories during the manufacturing and packing of the products and the importance of the reserve samplesClass-7Discussion on market complaints with examples and addressing them.Class-8Discussion on recall and return of the products from the market.{Discussion on various verticals on QA functions in the pharma industry in detail.Explanation of each vertical with a dummy format of the document that will be followed in manufacturing units.Coordination with all the below verticals is very much important for the release of a product into the market.}Class-9Concepts of Validations.Class-10Concepts of Cleaning validation Class-11Concepts of computer system validationClass-12Concepts of QualificationsClass-13Concepts of Vendor qualificationsClass-14Concepts of Annual product quality reviewClass-15Batch release procedure in pharma industry

Overview

Section 1: Pharmaceutical Quality Assurance - Ultimate Course (2023)

Lecture 1 Types of Pharmaceutical industry

Lecture 2 Pharma industry in India–-Various approvals required for running a pharma plant

Lecture 3 Guidelines as per USFDA that are to be followed during the manufacturing

Lecture 4 Various Quality assurance checks during manufacturing and packaging

Lecture 5 Discussion on hold time studies concepts

Lecture 6 Collection of various samples during the manufacturing and packing

Lecture 7 Market complaints with examples and addressing them

Lecture 8 Discussion on recall and return of the products from the market.

Lecture 9 Concepts of Validations.

Lecture 10 Concepts of Cleaning validation

Lecture 11 Concepts of computer system validation

Lecture 12 Concepts of Qualifications

Lecture 13 Concepts of Vendor qualifications

Lecture 14 Concepts of Annual product quality review

Lecture 15 Batch release procedure in pharma industry

Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences,Graduate or postgraduate degree in Chemistry,Graduate or postgraduate degree in Life sciences