4.50
(6 Ratings)

Why FDA Regulatory Inspection Comes?

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About Course

FDA may conduct an regulatory inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem.

What will you learn

In this course, you will learn about the why FDA regulatory inspections come and it’s benefit.

Language: English

How to Download Course certificate: Watch Video

About the instructor

Dhaval Surti
Mr. Dhaval Surti, holds a Degree in Pharmacy, from A.R. College of Pharmacy, Vallabh Vidhyanagar, Gujarat, India and Diploma certification in management from Indira Gandhi National Open University. In his vast experience of more than 18 years, he had worked in injectable manufacturing, validation, quality assurance and regulatory audits. He has been part of 4 injectable manufacturing project qualification and has rich experience of project and qualification. He has worked with reputed companies in India includes Sun Pharmaceuticals, Halol-Gujarat, Zydus Pfizer Oncology Pvt. Ltd- Ahemedabad, Aculife Healthcare Pvt. Ltd, Ahmedabad and Emcure Pharmaceuticals Ltd., Ahmedabad. He has also undergone numerous training programs such as MHRA GMP Inspection and Regulatory Workshop conducted by MHRA, ‘Auditor’s Qualification Course’, ‘Cleaning validation’, ‘Process Validation-The Lifecycle Paradigm’, ‘Continuous Process Verification’, training on GAMP5, Quality Risk Management ICH Q8, Q9, Q10 Regulatory Expectations and Practical consideration, Validation in Manufacturing’. As Quality Assurance Head, he led various quality assurance functions which includes validation, in-process quality assurance, quality management system, quality assurance in quality control, training and documentation. In his role as a validation head at Zydus Pfizer Oncology Pvt. Ltd, he has gained rich of experience in area qualification, smoke studies, Equipment qualification (Liquid, Lyophilized, Terminal Sterilized), Media Fills (Liquid, freeze dryer, PFS), Utilities Qualification, Freeze dryer qualification, Process and Cleaning Validation, 21 CFR Part 11 compliance, Cleaning Validation. He holds experience in injectable manufacturing in his initial association with Sun Pharmaceuticals Ltd, Halol, which includes Liquid Manufacturing, Filtration and Filling (Aseptic, Freeze Dried and Terminal Sterilized), Suspension Manufacturing, Filtration and Filing, Emulsion Manufacturing, Filtration and Filing, Pre-filled Syringe, Infusion bag filling, Packing line qualification and operation. Dhaval Surti have a deep desire to bring a positive change to the careers of Pharma Professionals by sharing the experience & knowledge that I gained during my career.

Course Curriculum

Why FDA Regulatory Inspection Comes?

  • SOP
    03:15

Student Ratings & Reviews

4.5
Total 6 Ratings
5
3 Ratings
4
3 Ratings
3
0 Rating
2
0 Rating
1
0 Rating
MF
3 days ago
Excellent
AD
4 months ago
Good
Jayesh Prajapati
5 months ago
Good
KV
6 months ago
Yes but i\'m from Canada..Do you have it in english?
AA
6 months ago
Awesome
SS
6 months ago
Excellent
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