Quality Management System(Qms) In Pharmaceutical Industry

Deviations, OOS, OOT, Change control, market Complaints, Risk Management, Root Cause Investigation

What you'll learn

Discussion on Deviation Handling

Discussion on Out of specifications and out of trends

Discussion on Change control handling

iscussion on handling of market complaints

Root cause investigation and methodologies

Risk management

Corrective actions and preventive actions and Effectiveness monitoring

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 Management System (QMS) in pharmaceutical industry  Course DetailsClass -1: Introduction on QMS Class -2: Discussion on deviation handling Class-3: Discussion on Out of specifications and out of trends Class-4: Discussion on Change control handling Class-5: Discussion on handling of market complaints Class-6: Root cause investigation and methodologies 1 Class-7: Root cause investigation and methodologies 2 Class-8: Risk management Class-9: Corrective actions and preventive actions and Effectiveness monitoringA Pharmaceutical Quality Management System (QMS) develops and ensures quality procedures in various product life cycle stages such as manufacturing and product testing.It includes all the critical stages of drug manufacturing, including:FormulationMethod developmentFacilitiesUtility systemEquipmentIt ensures that the final product is according to customer requirements, as well as regulatory requirements which the manufacturer is obliged to follow.It uses monitoring methods such as Quality Assurance to prevent quality deviation and emphasizes quality system documentation to record all problems and their solutions.Current Good Manufacturing Practice (cGMP)cGMP is a regulation enforced by the Food and Drug Administration (FDA), the US federal agency is responsible for safe production of drugs. The cGMP focuses on the manufacturing process.The product must be safe for human consumption, with quantity, quality, and purpose taken into consideration. The output must be free from contamination, risk, and most importantly, prevent mix-up of one product with another product.The FDA inspects its accredited manufacturers for cGMP compliance. If FDA finds non-compliance with cGMP regulation and serious drug adulteration, the manufacturer is directed to recall the product. Failure to follow the subsequent FDA directions can result in seizure, fines, and jail time.

Overview

Section 1: Quality Management System(QMS) in Pharmaceutical Industry

Lecture 1 Introduction to QMS

Lecture 2 Discussion on Deviation handling

Lecture 3 Discussion on Out of specifications and out of trends

Lecture 4 Discussion on Change control handling

Lecture 5 Discussion on handling of market complaints

Lecture 6 Fish Bone Diagram & 5 Why Technique

Lecture 7 Root cause investigation and methodologies 2

Lecture 8 Risk management

Lecture 9 Corrective actions and preventive actions and Effectiveness monitoring

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