Date

June 3, 2020

Duration

60 -75 minutes

Time

9:30 PM PDT |10:00 AM IST

Level

Advanced Professional

Why you should attend?

Ever since the issuance of USFDA’s guidance on “General Principles of Software Validation” in 2002, the fog concerning validation has resulted in volumes of documentation. Users proceeded to validate their systems believing that it’s “better to be safe than sorry” and that “large volumes of documentation are impressive”. But the USFDA realized that the industry’s approach to validation with such beliefs did not meet the guidance objectives. Consequently, they are contemplating the adoption of a transformation approach to audit validation. Under this approach, an audits’ primary focus would be to assess the process by which they feel assured that systems function as designed. Such a transformational change in audit strategy is being referred to as Computer System Assurance (CSA) instead of Computer System Validation. (CSV).

The webinar has been designed for those involved in the development and/or validation of biopharmaceutical products and processes, equipment installation and maintenance, computerized and process control systems, facilities, and utilities and manufacturing processes. It focusses on the key differences between CSV and CSA and prepares you to stay ahead of the validation curve by proactively adopting CSA concepts into your validation strategy. The design assumes that webinar attendees have the background and experience in validation.

In this webinar, the instructor will discuss the proposed CSA guidance, the business efficiencies that CSA provides, and how quality risk management outcomes may be utilized to effectively obtain assurance of validation

Areas covered:

  • Validation pain points as they exist today
  • Why CSV is being obsoleted
  • The key principles of CSA
  • The RAMP model and how it compares with GAMP
  • Different test types in CSA, and how and where to use them
  • Documentation requirements for CSA

Key learning objectives:

  • Understand the proposed CSA approach
  • Maximize the results of Risk Assessment
  • How to document validation under the CSA approach
  • Roll-out validated systems in record time and within budget
  • Learn how a paperless validation integrated environment supports CSA

Who will benefit?

Professionals across:

  • Quality Assurance/ Quality Control
  • Product and Process Development
  • Validation
  • Manufacturing Operations
  • Engineering
  • Regulatory Affairs


Instructor Bio

Chinmoy Roy is a seasoned life science professional and SME with a skill set that crosses multiple areas – from engineering to laboratory systems and validation to quality processes. He uses his experience to help companies improve their quality culture. At Genentech, he led and directed a team of over 50 people in design, installation and obtaining “fit for use” certification for the world’s largest paperless biopharmaceutical manufacturing facility. In his current role he consults worldwide helping troubled companies turn themselves around through data integrity audits, devising data integrity programs and training employees in Data Integrity Best Practices. In 2019 he received the “Best Speaker of the Year” award from the Institute of Validation Technology (IVT/UBM), USA.

Chinmoy has authored several QA Governance documents and facilitated numerous Quality Risk Assessments for his client companies. He was invited to present and conduct workshops at several worldwide conferences. He has been included on teams of former FDA inspectors to provide them with audit assistance in areas of expertise such as CSV and Data Integrity. He has also been on several Data Integrity discussion panels with FDA departmental managers and industry experts.

Chinmoy is an Electrical Engineer from IIT, Kharagpur, India, and holds a Master’s Degree in Computer Science from WPI, Massachusetts, USA. He resides in the San Francisco Bay area.

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One thought on “The difference between CSV and CSA

  1. Need to understand, How CSA incorporated in paperless validation.

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