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.