This seminar on CSV will explore proven techniques for reducing costs linked with implementing and maintaining computer systems in regulated environments. This course will not only provide a full understanding of the regulations and guidelines for raw data and other records but also provide templates and examples to develop inspection ready documentation.

 The objective of the seminar is to provide an overview of regulations like 21CFR Part 11 and GAMP 5; in addition to software validation concepts, CSV deliverables, and data integrity and security. It also aims at offering the opportunity to understand the basics in Computer System.

 WHY SHOULD YOU ATTEND

 Get the concentrated inputs from Industry leader who is constantly involved in Computer Systems Validation in India and Abroad.

• Bullet point on how to perform best can help you and your company produces great compliant results.

• Reduce the professional stress by mastering the CSV.  It is the most troubling issue of the time for all Pharma company.

• Make gain for your Company and thereby increasing your professional Success.

• To make Pharma People aware about latest regulatory Guidelines.

• Motivate them to learn it and help them avoid 483, Warning Letter and data Integrity related issues.

• Provide ROI in the form of improved Quality, Less rejection and Confidence of doing it Right For the First time

 The following areas will be covered: 

·         Making Pharma people aware of the latest regulatory guidelines.

·         Helping them avoid 483-warning letters and data integrity related issues.

·         Providing ROI in the form of improved quality, fewer rejections and confidence of doing it Right For the First time.

·         Having good control on SDLC life cycle, data life cycle and GxP Work flow

 Speaker Profile:

 Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems. He has 30 years of experience as  Software Validation Specialist, Expert Trainer CSV-  Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9, Risk assessment- Proactive CSV Approach . He has worked with nearly 80% of the biggest companies in the pharmaceutical industry as a CSV Consultant and Trainer.

 Don’t miss this amazing learning opportunity. Be an early bird and RESERVE YOUR SEAT now!

 Thank you! Looking forward to meet you at the seminar with other prominent Indian pharmaceutical companies.

For more detail please click on this below link:

https://goo.gl/w7zCHP

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Tel: +91-80-6566-0080

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