Validation Requirements for Pharmaceuticals

Validation Requirements for Pharmaceuticals

This course will disuss in detailed about stability study requirements, process validation, analytical method validation, water system validation and equipment qualification. All the information is based on current FDA, EU,PIC/S and other regulatory agencies. This learning will upgrade your learning with respect to qulification and validation.

All these learning session will first start with introduction and awareness about the topic.

The Qualification learning will take you through Validation & Qualification concept,Organising and planning for validation,Understanding VMP, VP,VR and VMR concepts,Role of QRM in Qualification,Process flow for Qualification,Understanding different steps in qualification, Analytical instrument qualification as per USP

The process validation learning will take you through understanding different guideline expectations about process validation EU,FDA,ANVISA,TGA,WHO etc., Common regulatory expectations, Traditional approach and Hybrid approach, CQA and CPP, What is normally missing in process validation, Concurrent validation approach, Continued process verification vs product Quality Review, Designing process validation protocol/Report, Detailed difference between EU and FDA guide etc.

The analytical method validation learning will make you aware about FDA expectations about analytical method, Brief on QBD approach, How practically approach for validation, Role of QRM in analytical method validation, Brief information on ICHQ14 - Analytical method development, Detailed on ICHQ2(R1) – Analytical method validation, Understanding of all validation parameters, Overall evaluation, Revalidation criteria.

The water system validation session will make you understand about Different types and usage of water, Qualification and Validation of water purification system, Identify the suitability of the water system, Why three phases PQ or water system validation - Details, Sampling issues and some common problems, Developing Water system validation – Life cycle approach, Discussion on some FDA warning letter observations.

This course will take to understand practical approach for validation requirements as per FDA, EU and other guidelines

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What you will learn

• This course has been updated to include various validation aspects which includes, equipment qualification and validation, process validation, short brief about cleaning validation, Analytical method validation, water system validation

Rating: 3.05

Level: Intermediate Level

Duration: 9 hours

Instructor: Hitendrakumar Shah