Presenting Documents During Regulatory Inspections In Pharma


Pharma regulatory inspections by USFDA & other regulatory agencies are a common scenario in the pharma manufacturing units. The documents presented during these inspections are a very important assets & proper preparation is required for that specially the person who is going to present the documents to the audit inspector should be the best prepared. In this mini course learn what all should to be taken care of during these inspections. The various regulatory agencies which carry these regulatory audits / inspections are USA – Food and Drug Administration (FDA), UK – Medicines and Healthcare Products Regulatory Agency (MHRA), Australia – Therapeutic Goods Administration (TGA), India – Central Drug Standard Control Organization (CDSCO), Canada – Health Canada, Europe – European Medicines Agency (EMEA) etc.

What will you learn

  • How to present the documents during pharma regulatory audits
  • How to speak & what to speak
  • How to be prepared with documents

Language: English

How to download course certificate: Watch Video

Topics for this course

2 Lessons07m 56s

Presenting Documents In Audit

Part 1: How to present the documents & handle questions4:37
Part 2: How to communicate3:19

About the instructor

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.
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6 Courses

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Pharma manufacturing

Material Includes

  • 2 Learning Videos
  • 1 Course Certificate

Enrolment validity: 30 days

Target Audience

  • Pharma Production
  • Quality Control
  • Quality Assurance
  • Pharma Engineering
  • Warehouse Packaging

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