Hitendrakumar Shah

Hitendrakumar Shah

A Quality-oriented professional with over 25 years of experience in Production, 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, building 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: Production, Quality assurance, and Quality Control department for more than 13 years.
- Audits faced- USFDA (9 times), ANVISA, MHRA, MCC, TGA, WHO audit, EU regulatory (12 times) &Many

Process validation

0:59

Process validation

12 сағат бұрын

Cleaning Validation - Should we wait for swab and rinse samples results?

0:48

Cleaning Validation - Should we wait for swab and rinse samples results?

Күн бұрын

GMP,cGMP and Advance GMP Program

4:43

GMP,cGMP and Advance GMP Program

14 күн бұрын

Cleaning Validation

0:45

Cleaning Validation

14 күн бұрын

Services offered to Pharmaceuticals

0:49

Services offered to Pharmaceuticals

6 ай бұрын

Pharmaceutical Water System - Key Questions and Answers

20:43

Pharmaceutical Water System - Key Questions and Answers

7 ай бұрын

Pharmaceutical Quality System (PQS) - Key Questions and Answers

17:24

Pharmaceutical Quality System (PQS) - Key Questions and Answers

8 ай бұрын

Cleaning Validation - Key Questions and Answers - III

17:32

Cleaning Validation - Key Questions and Answers - III

8 ай бұрын

Process Validation - Key Questions and Answers 2

12:35

Process Validation - Key Questions and Answers 2

8 ай бұрын

Process Validation - Key Questions and Answers 1

13:23

Process Validation - Key Questions and Answers 1

8 ай бұрын

Product Quality Review (PQR) Key Questions and Answers

14:28

Product Quality Review (PQR) Key Questions and Answers

9 ай бұрын

Cleaning Validation - Key Questions and Answers -II

11:38

Cleaning Validation - Key Questions and Answers -II

9 ай бұрын

Cleaning Validation - Key Questions and Answers - I

15:36

Cleaning Validation - Key Questions and Answers - I

9 ай бұрын

Delta Ferrite Content in GMP Welding

13:03

Delta Ferrite Content in GMP Welding

9 ай бұрын

FREE LEARNING PLATFORM

0:16

FREE LEARNING PLATFORM

10 ай бұрын

How to Submit Comments on DRAFT FDA Guidelines

40:06

How to Submit Comments on DRAFT FDA Guidelines

10 ай бұрын

Training Policy in Pharmaceutical

9:39

Training Policy in Pharmaceutical

Жыл бұрын

FDA Form 483 and Warning Letter - Understanding FDA Procedure

56:04

FDA Form 483 and Warning Letter - Understanding FDA Procedure

Жыл бұрын

Good Auditing Practices

1:12:03

Good Auditing Practices

Жыл бұрын

Quality Risk Management ICH Q9(R1)

1:09:08

Quality Risk Management ICH Q9(R1)

Жыл бұрын

Computer Software Assurance

1:04:52

Computer Software Assurance

Жыл бұрын

Electronic Data Auditing Techniques

1:15:39

Electronic Data Auditing Techniques

Жыл бұрын

Good Review Practices - A Risk Based Approach

1:13:17

Good Review Practices - A Risk Based Approach

Жыл бұрын

Good Behaviour Practices - GMP Training

56:24

Good Behaviour Practices - GMP Training

Жыл бұрын

PROCESS VALIDATION STAGE-1 "PROCESS DESIGN"

9:00

PROCESS VALIDATION STAGE-1 "PROCESS DESIGN"

Жыл бұрын

Excel Spreadsheet Validation

9:49

Excel Spreadsheet Validation

Жыл бұрын

Process Capability & Process Capability Index

11:43

Process Capability & Process Capability Index

3 жыл бұрын

Business Continuity Plan (BCP)

1:01:03

Business Continuity Plan (BCP)

3 жыл бұрын

Value Addded Auditing Techniques

1:18:31

Value Addded Auditing Techniques

3 жыл бұрын

Пікірлер

@ramakrishnaguttula7941

@ramakrishnaguttula7941 2 күн бұрын

Correct Sir

@ramakrishnaguttula7941

@ramakrishnaguttula7941 2 күн бұрын

Good Informative sir

@IshaShah-my2jh

@IshaShah-my2jh 2 күн бұрын

very informative video

@AUDITS-wm2dg 2 күн бұрын

Thanks sir

@IshaShah-my2jh

@IshaShah-my2jh 5 күн бұрын

very informative video thank you sir

@hitendrakumarshah3718

@hitendrakumarshah3718 5 күн бұрын

So nice of you

@suryashree5941

@suryashree5941 5 күн бұрын

Here only you discussed accelerated or intermediate. these conditions only for 6 months, 0,6,9, (exatrapolated 12) But u r recommended examples are long term upto 36 or retest period Sir please explain why u mentioned long term and how to consider long term

@hitendrakumarshah3718

@hitendrakumarshah3718 5 күн бұрын

This training based on ICH guidelines for bracketing and matrixing. You can follow link below for further learning Stability Study in Pharmaceutical Industry kzbin.info/www/bejne/aHi8XmBoecmXj80

@ApnaPeacefulWarrior

@ApnaPeacefulWarrior 5 күн бұрын

👍

@hitendrakumarshah3718

@hitendrakumarshah3718 5 күн бұрын

🙏🏻

@user-zh8um1dc8v

@user-zh8um1dc8v 6 күн бұрын

Why do you Indians not many of you use Arabic language video

@bhushanpdhangar1801

@bhushanpdhangar1801 8 күн бұрын

Sir Training to be provided in hindi also

@janichem7864 11 күн бұрын

Sir which guidelines follow ,either MHRA or FDA If OOT result identify in dissolution test,so in which phase we perform further 6 sample test.to chech either product meet s2 critera or not

@isovenu 15 күн бұрын

Flight attendants communication is wonderful and appropriate example 👍

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Thank you

@isovenu 15 күн бұрын

Request you to please send me the presentation 😄

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Hi, I have shared during the LIVE session. After that, I will not have it.

@poojabhan6629 16 күн бұрын

Sir how I can I become auditor sir

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

You need formal training and then practical training

@MrAjit064 18 күн бұрын

YES

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Thanks

@prabhatsharma6138

@prabhatsharma6138 19 күн бұрын

please provide pdf sir

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Hi, I have shared during the LIVE session. Hope you attended the LIVE session.

@sankaramPampanaboyina

@sankaramPampanaboyina 21 күн бұрын

Sir, pls share the link

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Which link?

@amolgaikwad9491

@amolgaikwad9491 23 күн бұрын

Good information

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Thanks

@gangasridhar 23 күн бұрын

Sir, your training session is very good. We are getting valuable knowledge from your sessions. Thank you for the sessions. Please share the training material.

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Thank you. I have shared during the LIVE session. Hope you attended the LIVE session.

@manojmodi414 25 күн бұрын

Thank you very much Sir

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Welcome

@mojardesh7908 25 күн бұрын

If UCL and LCL are out side from the specification during normal analysis, then how the control limit will be determined for implementation ?

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

How you calulate UCL and LCL? You need to evaluate the trend

@mchitra2165 26 күн бұрын

Very nicely explained all important points. Thanks

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Welcome

@madanmohan9660

@madanmohan9660 26 күн бұрын

Yes I need

@hitendrakumarshah3718

@hitendrakumarshah3718 26 күн бұрын

What exactly you need?

@mojardesh7908 28 күн бұрын

In PQR how we justify that which tool is useful for less number of batches and large number of batches?

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

You should able to evaluate the data. You can choose any suitable tool

@lokeshkota1476

@lokeshkota1476 Ай бұрын

Hi sir

@hitendrakumarshah3718

@hitendrakumarshah3718 26 күн бұрын

Hi, hope you’re doing well

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

You can download the training presentation from the link below - we.tl/t-SG2nFrVncw The link will expire within couple of days. So, download ASAP.

@venkatalaxmi6778

@venkatalaxmi6778 Ай бұрын

Sir can u pls share the PPT to me

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

The PPT is shared during the LIVE Training only.

@deepakchaitanyareddy

@deepakchaitanyareddy Ай бұрын

PLC and scada comes under which category of GAMP

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

These are the complex systems

@vijaypatidar2536

@vijaypatidar2536 Ай бұрын

Nice sir

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

Thanks

@mayursarolkar Ай бұрын

Please provide material

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

Hi, the training material is shared during the LIVE training. After that, I can not share it.

@ashokdara2115 Ай бұрын

Hello Sir, I didn't find KPI in ICH Q7

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

You need to refer APIC guide - interpretation of ICH Q7 guide

@PradeepKumar-bs6hy

@PradeepKumar-bs6hy Ай бұрын

what is the difference between approaches and technique and when we have to use approach or technique?

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Please elaborate your question. It is not clear to me

@temimihiba3095

@temimihiba3095 2 ай бұрын

Thanks great content

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

Thanks

@MOHAMMADMAIMUNUDDINSOHEL

@MOHAMMADMAIMUNUDDINSOHEL 2 ай бұрын

A very informative & helpful content. Thank you sir. For your effort to have learnt me

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

Thank you. Please keep learning

@janichem7864 2 ай бұрын

Any Detail Webinar related to ISO 17025

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

Sure. Will let you know

@janichem7864 2 ай бұрын

Sir any Webinar related to QC Compliance

@hitendrakumarshah3718

@hitendrakumarshah3718 Ай бұрын

Sure, will organise the same

@gangadharveeramallu3910

@gangadharveeramallu3910 2 ай бұрын

Sir plz share the link for downloading the presentation

@hitendrakumarshah3718

@hitendrakumarshah3718 12 күн бұрын

Hi, I have shared during the LIVE session. Hope you attended the LIVE session.