Mr.Hitendra Kumar Shah

Area Of Expertise : Training for more than 15 years. To date trained approximately more than 10,000 participants. Audit and Compliance, end-to-end support for regulatory inspections, Qualification, and validation, Vendor audits, etc.
23 Years Of Experience
Training Industry : Multi Industry

A Quality-oriented professional with over 23 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, 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.

2 results Found
Live Webinar

Data Integrity for production personnel

Nowadays, data integrity observations are of paramount importance. Because the observations are categorized as Major in nature. This training will help to understand production personnel and the personnel related to the production department (QA, QC, developme ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Jun 01, 2023
Recorded Webinar

Current GXP expectations on Water system validation compliance

The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...

  • Basic & Intermediate & Advanced
  • 90 Mins