![Hitendrakumar Shah](/img/default-banner.jpg)
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Hitendrakumar Shah
Индия
Добавлен 2 апр 2018
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
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
Third Party Audit Services
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Просмотров: 196
Видео
GAMP 5 - Hardware Categories
Просмотров 131День назад
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GAMP 5 Sofware Categories
Просмотров 86День назад
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Cleaning Validation - Prospective, Concurrent and Retrospective Concept
Просмотров 161День назад
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Do you have SOP for audit trail review based on risk based approach
Просмотров 16414 дней назад
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CPP vs CQA
Просмотров 28614 дней назад
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Why Continued Process Verification
Просмотров 20921 день назад
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NADH GXP COMPLIANCE SERVICES
Просмотров 21928 дней назад
Dear all; I have been serving hashtag#pharmaceuticals for more than 23 years. Our company NADH GXP COMPLIANCE SERVICES !!! is serving the hashtag#pharmaceuticalcompanies for a long period. Our team is expertise in; 1. Different types of hashtag#audits - Mock Audits, Third-party Audits, GAP audits, Due diligence audits, for cause audits, internal audits etc. 2. Training - We provide in-house has...
Why root cause analysis? And not stem or leaf cause?
Просмотров 170Месяц назад
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Cleaning validation Vs Cleaning Verification
Просмотров 150Месяц назад
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Process validation
Просмотров 169Месяц назад
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Cleaning Validation - Should we wait for swab and rinse samples results?
Просмотров 225Месяц назад
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Pharmaceutical Water System - Key Questions and Answers
Просмотров 2 тыс.8 месяцев назад
Pharmaceutical Water System - Key Questions and Answers
Pharmaceutical Quality System (PQS) - Key Questions and Answers
Просмотров 1,4 тыс.9 месяцев назад
Pharmaceutical Quality System (PQS) - Key Questions and Answers
Cleaning Validation - Key Questions and Answers - III
Просмотров 1,7 тыс.9 месяцев назад
Cleaning Validation - Key Questions and Answers - III
Process Validation - Key Questions and Answers 2
Просмотров 8429 месяцев назад
Process Validation - Key Questions and Answers 2
Process Validation - Key Questions and Answers 1
Просмотров 1 тыс.9 месяцев назад
Process Validation - Key Questions and Answers 1
Product Quality Review (PQR) Key Questions and Answers
Просмотров 1,5 тыс.10 месяцев назад
Product Quality Review (PQR) Key Questions and Answers
Cleaning Validation - Key Questions and Answers -II
Просмотров 1,4 тыс.10 месяцев назад
Cleaning Validation - Key Questions and Answers -II
Cleaning Validation - Key Questions and Answers - I
Просмотров 2,9 тыс.10 месяцев назад
Cleaning Validation - Key Questions and Answers - I
Delta Ferrite Content in GMP Welding
Просмотров 62510 месяцев назад
Delta Ferrite Content in GMP Welding
How to Submit Comments on DRAFT FDA Guidelines
Просмотров 39511 месяцев назад
How to Submit Comments on DRAFT FDA Guidelines
FDA Form 483 and Warning Letter - Understanding FDA Procedure
Просмотров 2,2 тыс.Год назад
FDA Form 483 and Warning Letter - Understanding FDA Procedure
PPT
Please share the cleaning validation presentation Sir
What is purpose to do this vedor assessment
Sir How NDSRI impurities risk assessments carried out ??
Bijoy Ghosh here
Is this evaluation required for Domestic product, is our India FDA need Nitroseminr impurity evaluation.
Very valuable information thanx sir
Most welcome
Sir could you please make a video on how to become an auditor. Explain qualification and eligibility criteria. If any other... Pls explain sir. Thank you 👍
Sure I will
@@hitendrakumarshah3718 thank you sir
Nitrosamine impurities topic
Sure. Will do the same
Y
Thanks
Please describe about step 6 which was not defined in PPT
Hi, it is described at about 30 minutes time point. But I think due to some techncial issue, the slide is not appearing. But the discussion is there realated to IQ.
Please share ppt sir
You can download training ppt from the link below we.tl/t-9BOgkOmbRm
Thanks for sharing
Thanks
nice info
Thanks
nice
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Thanks
Good info
Glad you think so!
Thanks for sharing
Its my pleasure !!!
Thanks
Welcome
Thanks
Welcome
welcome
Nice
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Nice
So nice
Good
Thanks
Nice information
welcome
Nice Information
So nice
Thanks
Its my pleasure !!!
Nice sir
Thanks and welcome
Nice
Very nice
Nice
So nice
Nice explained
welcome
Perfect
welcome
Thank you
You're welcome
Thanks
welcome
Thanks
welcome
Thanks
welcome
Thanks
welcome
Thank you so much for clarification
welcome
You're most welcome
Thanks
Welcome
Thanks for sharing
My pleasure
Thanks
welcome
Thanks
welcome
Thanks
Welcome
Thanks
Welcome
Thanks
welcome
Thank you for sharing your contact details
Our pleasure!
Thanks
welcome
Thank you for clarity
Keep watching
Nice Sir
Thanks and welcome
Thank you sir
So nice of you
What is "Not of standard quality" sir any guideline available.
You can refer the Schedule M