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


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