Online Live Training


As Per FDA Expectations

8th – 9th October 2020 | 10:00 AM | 6 Hours (Each Day)

Course Expert

Mr. Hitendrakumar Shah

A Quality-oriented professional with over 2 decades 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, and Schedule-M Guidelines.


The FDA has issued numerous Warning Letters emphasizing Computer System Validation & Data Integrity non-compliance. CSA requires the use of critical thinking, whereby facts are analyzed impartially to identify patterns, to assess trends and theories, and to evaluate outcomes. Applying a good risk management approach is the foundation that the rest of your validation approach can rest on. Understanding your business process, critical data and requirements that support that critical data should drive the right design- testing efforts. The session provides the industry practitioners the perspective to utilize the appropriate combination of CSA activities to drive enhanced quality and safety resulting in reduced risk.

Who Should ATTEND?

  • Validation
  • Quality Assurance
  • Engineering
  • IT
  • Data Integrity
  • Quality Control
  • Manufacturing Management
  • Laboratory Management
  • Regulatory Affairs

Register Now

Course Investment: INR 6000/-
To confirm your position, Contact now

This course is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection and statistics.

For Registration

Utsav Sahani – Head Registrations

[email protected] | +91 93214 97158