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
- 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?
- Quality Assurance/ Quality Control
- Product and Process Development
- Manufacturing Operations
- Regulatory Affairs