Duration: 90-120 minutes

June 3rd 2020 @ 8:30 PM PDT | 9:00 AM IST (June 4th, 2020)

Level: Advanced Professional

Why Should You Attend?

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

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

Areas Covered in the Webinar:

  • What are the pain points of Validation as it exists today
  • Why is CSV being obsoleted
  • Key principles of Computer Systems Assurance; CSA
  • What is the new RAMP model and how does it compare with GAMP
  • What are the different test types in CSA and where and how to use them
  • What are the documentation requirements for CSA

Key Learning Objectives of your Topic:

  • Understand the proposed CSA approach
  • Learn how to maximize the results of your Risk assessment
  • How to document your Validation under the CSA approach
  • How to roll out validated systems in record time and under budget
  • How paperless validation’s integrated environment supports CSA

Who will be benefited?

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

Instructor Bio:

Mr. Chinmoy Roy is a seasoned life science professional and SME with a skill set that crosses over in multiple areas from engineering to laboratory systems and validation to quality processes. He uses his experience to help companies in a variety of areas to assist them in improving the quality culture of the organization. At Genentech, he led and directed a team of 50+ people in the 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 by conducting Data Integrity audits, devising Data Integrity programs and training employees in Data Integrity Best Practices. In 2019 he was awarded “Best Speaker of the Year” by Institute of Validation Technology (IVT/UBM), USA.

He 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 professional conferences. He has been included on teams of former FDA inspectors to provide them with audit assistance in the areas of his expertise of CSV and Data Integrity. He has been on several Data Integrity discussion panels with FDA departmental managers and industry experts.

He is an Electrical engineer from IIT, Kharagpur and holds a MS degree in Computer Science from WPI. Massachusetts, US. He resides in the San Francisco Bay area.

We look forward to you joining us.

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