Agenda (10.30 - 15.30, including networking lunch)

Enabling pharma 4.0 in validation with case study example

Dr. José C. Menezes


Increasingly complex regulatory challenges in the pharma and biotech industry are forcing companies to go paperless and adopt an end-to-end digital approach in their manufacturing process. While digital validation and automation meet very complex product lifecycle needs, they are only enablers to the intelligence at the heart of manufacturing activity. Companies must not adopt enablers just to meet regulatory requirements but use them intelligently to move beyond, to a state of readiness and maturity that drives their manufacturing vision of the future. This is the culture that Pharma 4.0 is attempting to birth and evolve in the industry. In this session a customer use case will display how using a digital validation system has moved this company to get closer to Pharma 4.0.

Critical Thinking and Its Role in Computer Software Assurance (CSA)

Bjarne Wiboe

Principal Consultant

Ole Bernth

Principal Consultant

The FDA has introduced computer software assurance (CSA), a new approach to traditional computer software validation (CSV), bridging the gap between technology and guidance. The most significant difference between the two methods is that CSV focuses on documentation, i.e., a "test everything" approach, while CSA encourages us to use critical thinking to test more effectively.

The CSA Concept of NNIT encompasses four significant methodologies: 1. LEAN Risk Assessment 2. A comprehensive test strategy that utilizes an extended set of test types 3. Added value through Critical Thinking 4. Software Assurance to establish development processes in control based upon process control points and quality gates.

Overall, CSA provides multiple benefits over traditional Computer Systems Validation (CSV). It is faster, more efficient and offers improved quality assurance compared to CSV. In this session, we’ll discuss new options under CSA.

The Challenges of Paper-Based Logbook Management and How to Avoid Them

Sophia Vraka

Senior Solutions Engineer.

Good practices (GxP) regulations require life sciences companies to document equipment usage, cleaning status and other day-to-day manufacturing activities. When companies rely on paper-based logbooks and manual data entry to manage their logging activities, they expose themselves to human errors, poor data integrity, and a host of compliance risks, all of which can result in product quality issues, rework, and even the dreaded FDA Form 483 observations and warning letters. In this session we’ll examine the challenges of using physical logbooks and how a robust electronic logbook management solution can help you avoid them.

Moving to Pharma 4.0 Using Quality Risk Management

Margarida Ventura

Quality Risk Management Tech Lead

It is a regulatory requirement for Life Sciences companies to perform Risk Management and provide documented evidence to demonstrate compliance with regulation and a company’s own Quality Management System. Considering the Pharma 4.0 framework for adapting digital strategies, we will discuss how replacing spreadsheets with a collaborative, digital approach for Risk Management can assist with compliance, but also to significantly reduce cycle times.


17 Jul 2024

Why attend?

Networking opportunity with your peers

Learn how CSA flips the paradigm of validation

Discuss how the Pharma 4.0 framework affects risk management

See how to achieve a state of readiness and maturity that drives the manufacturing vision of the future in keeping with Pharma 4.0