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Validation Requirements for Pharmaceuticals

This course will take to understand practical approach for validation requirements as per FDA, EU and other guidelines
0.0
0.0/5
(0 reviews)
2 students
Created by Hitendrakumar Shah

9.2

CourseMarks Score®

10.0

Freshness

N/A

Feedback

7.9

Content

Platform: Udemy
Price: $11.99
Video: 8h 57m
Language: English
Next start: On Demand

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Detailed Analysis

CourseMarks Score®

9.2 / 10

CourseMarks Score® helps students to find the best classes. We aggregate 18 factors, including freshness, student feedback and content diversity.

Freshness Score

10.0 / 10
This course was last updated on 2/2021.

Course content can become outdated quite quickly. After analysing 71,530 courses, we found that the highest rated courses are updated every year. If a course has not been updated for more than 2 years, you should carefully evaluate the course before enrolling.

Student Feedback

We analyzed factors such as the rating (0.0/5) and the ratio between the number of reviews and the number of students, which is a great signal of student commitment.

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Content Score

7.9 / 10
Video Score: 8.9 / 10
The course includes 8h 57m video content. Courses with more videos usually have a higher average rating. We have found that the sweet spot is 16 hours of video, which is long enough to teach a topic comprehensively, but not overwhelming. Courses over 16 hours of video gets the maximum score.
Detail Score: 9.2 / 10

The top online course contains a detailed description of the course, what you will learn and also a detailed description about the instructor.

Extra Content Score: 5.5 / 10

Tests, exercises, articles and other resources help students to better understand and deepen their understanding of the topic.

This course contains:

0 article.
0 resource.
0 exercise.
0 test.

Table of contents

Description

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.

Requirements

• The person who is interested in learning should learn in focussed way to understand the concepts and practical approach.

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

This course is for

• Pharmacy students, Pharmaceutical professionals, consultants etc. This course is essential for auditors, quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers

How much does the Validation Requirements for Pharmaceuticals course cost? Is it worth it?

The course costs $11.99. And currently there is a 52% discount on the original price of the course, which was $24.99. So you save $13 if you enroll the course now.

Does the Validation Requirements for Pharmaceuticals course have a money back guarantee or refund policy?

YES, Validation Requirements for Pharmaceuticals has a 30-day money back guarantee. The 30-day refund policy is designed to allow students to study without risk.

Are there any SCHOLARSHIPS for this course?

Currently we could not find a scholarship for the Validation Requirements for Pharmaceuticals course, but there is a $13 discount from the original price ($24.99). So the current price is just $11.99.

Who is the instructor? Is Hitendrakumar Shah a SCAM or a TRUSTED instructor?

Hitendrakumar Shah has created 3 courses that got 8 reviews which are generally positive. Hitendrakumar Shah has taught 38 students and received a 3.9 average review out of 8 reviews. Depending on the information available, Hitendrakumar Shah is a TRUSTED instructor.

More info about the instructor, Hitendrakumar Shah

Pharmaceutical Compliance Consultant,cGMP Trainer & Auditor
A Quality oriented professional with over 21 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc. · Independently handled – Quality assurance and Quality Control department for more than 13 years.· Audits faced- USFDA (7 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (8 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.· Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV Visible spectrophotometer, AAS etc.· Technical support-o cGMP and data integrity gap audit.o Support in facing regulatory audits & compliance report reviewo Support in product development and/or regulatory submission or evaluation of readymade dossiers which can be used after site transfer for commercial manufacturing.· Expertise in GXP Computerised systems-o Major Software handled – Lab solution software, Empower 3 software, LIMS, TRIMS & Track wiseo Provide technical support to process owner during Computer system validation, Review of Computerised system validation documents for compliance, auditing the computer system supplier, performing GAP audit of Computerised systems, Evaluation of Computerised systems with respect to cGXP compliance , data integrity controls and ease of operating pragmatic approach· During tenure audited more than 500 vendors/suppliers and trained more than 5000 candidates. I am approved Auditor by the multinationals I worked and also I am CQI-IRCA Certified QMS/Lead Auditor as per ISO9001:2015).

9.2

CourseMarks Score®

10.0

Freshness

N/A

Feedback

7.9

Content

Platform: Udemy
Price: $11.99
Video: 8h 57m
Language: English
Next start: On Demand

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