Analytical Equipment Validation - Biopharma (Usp1058) Pharma

QC Lab Instrument, Real Time Project on Quant Studio RTPCR System with Indepth understanding of deliverables and process

What you'll learn

Industry Overview- Process Flow, SDLC; Types/ Usage/ Advantages/ Disadvantages, Quality Assurance; Compliance Requirements; Terminology, Types of Validation.

Analytical Equipment Validation, Types of Equipment

Deliverable - User Requirement Specification, Validation Project Plan, Design Qualification, Equipment Classification, Categorization, Vendor Protocol

Deliverable - Installation, Operational and Performance Qualification Protocol. Installation, Operational and Performance Qualification Report,

Deliverable - Requirement Tractability Matrix, Validation Project Report

Requirements

Graduate from Life science Background including BTech Biotechnology, Biochemistry, Biomedical , BSC Biotech, MSC Biotech or related field.

Professionals working in LifeScience Industry and looking for career enhancements.

Description

What will you learn in this course?About Course:· Validation is critical in the pharmaceutical, clinical trials, medical devices, food, and biological industries. Validation enables one to determine and show that a specific action is upholding the specified degree of compliance· This course is designed for individuals who require a basic but thorough understanding of all validation in the pharmaceutical sector. The goal of this course is to provide professional-level education in the area of Validation in BioPharma industries.· These are crucial challenges for pharmaceutical businesses, clinical research organizations, and biotech corporations.· The course focuses on regulatory affairs concepts that pharmaceutical businesses must adhere to in order to sell their products both domestically and internationally.· Understanding the foundational ideas and theories of pharmaceutical validation will be beneficial.Overview of pharmaceutical validation, including how to do it and the key areas to consider during the process.Scope:· Learn the Fundamentals of Biotechnology / Pharmaceutical Validation.· Understanding the significance of pharmacological validations and the underlying principles. To develop a thorough understanding of/increase comprehension of:· Analytical Equipment ValidationWho should take this course?Who Should Apply?:· This training is suitable for anyone involved in validation efforts in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical, and Skin/Cosmetic industries.· People participating in validation operations ranging from product development to post-approval manufacturing concerns will gain a comprehensive understanding of what regulators are looking for.· Documentation involves research chemists, quality control chemists, CROs, productions, RAs, and others.· Personnel directly involved in process/product development, production, and quality control/assurance departments will benefit.· Beginners will learn the ins and outs of Pharma Validation, while experienced professionals can expect to refresh· Graduates in any stream of science are eligible to apply.

Overview

Section 1: Demo Session - Industry Overview

Lecture 1 Introduction

Lecture 2 Industry Overview- Process Flow, SDLC; Types/ Usage/ Advantages/ Disadvantages,

Lecture 3 Equipment Validation, Types of Equipment, Deliverable

Lecture 4 Equipment Validation: Deliverable - Continued…

Lecture 5 Equipment Validation: Deliverable - Continued…

BTech Biotechnology, Biochemistry, Biomedical or related Field. BSC Biotech, MSC Biotech.