Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 30th Mar'25 to 09th Apr'25
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
Data Integrity in Quality Control Laboratories
Data Integrity is currently the major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. The emphasis of all regulators is on the AL ...
- Basic & Intermediate & Advanced
- 60 Mins
- Apr 22, 2025
Live Webinar
Brief understanding of CAPA (Corrective and Preventive Action)
CAPA stands for Corrective and Preventive Action. It's a systematic process used in industries like manufacturing, healthcare, and pharmaceuticals to identify, address, and prevent problems or non-conformities. CAPA is a crucial part of a quality management s ...
- Basic & Intermediate & Advanced
- 60 Mins
- Apr 28, 2025
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