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.

3 results Found
Live Webinar

Quality Risk Management ICH Q9(R1)

The customer and regulatory agencies expectations are very clear. Quality Risk management is back bone in all - processes, procedures, facilities & systems, practices etc. The basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk M ...

  • Basic & Advanced
  • 90 Mins
  • May 23, 2024
Live Webinar

Stability Studies for the pharmaceuticals ICH Q1A(R2)

The guideline defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States. The purpose of stability testing is to provide eviden ...

  • Basic & Advanced
  • 90 Mins
  • Jun 10, 2024
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