Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study

Presented by: Linda Lagrou, Senior Manager IT Quality, Abbott LaboratoriesGaurav Walia, Senior Global Director and Sr. Associate Partner, PQE Group •    Demonstration of CSA practical execution•    Real world highlights of CSA implementation case study•    Use of critical thinking with the implementation•    Use of automation tools with the CSA Approach•    Overarching […]

To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

Read More »

A Sustainable Model For Production System Excellence

Presented By: Woon Lit Ong, Senior Director, APAC & AfME Operational Excellence, Pfizer Global Supply and Rajnish Narula, Director, Business Excellence, Tuas, Pfizer Global Supply Learn about the design, deployment and sustainment of the Pfizer Production System called Integrated Manufacturing Excellence (IMEx, similar to the Toyota Production System TPS). IMEX helps to establish a standardized […]

To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

Read More »

CSV – Effective System Level Risk Assessment

Presented By: Rohit Tyagi, President, SAGAX Team Key Highlights: Regulatory Compliance: How implementing robust CSV processes is essential for pharmaceutical companies to ensure product quality and patient safety, while remaining compliant with regulations. Risk Identification: Learn how to properly assess risk in using a computerized system focusing on patient safety. Data Integrity Assurance: Identifying potential […]

To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

Read More »

Digital Cleaning Validation Lifecycle

Presented by: Rui Almedia, Director, Product Life Cycle Management Services, ValGenesis. Inc. Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how […]

To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

Read More »

Develop a Strategy to Transition to Paperless Validation C&Q

Presented by: Philip Jarvis, Director, Integrated C&Q and Paperless Strategy, Veqtor & Mark Geldard, Director Sales EMEA, Kneat • Discuss how to develop ROI and momentum for a transition to paperless C&Q • How to influence key stakeholders, and build a culture of digital transformation  • Key watch outs and learnings including: o Education on […]

To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

Read More »

Recommended for you

Categories

Categories

Recommended for you

Categories

Categories

Be first to know about our next events!

Register to receive updates

31 E Kings Highway
2nd Floor Haddonfield, NJ 08033

  • Email: info@kenx.org
  • Phone: 858 649 3251
  • Email: info@kenx.org
  • Phone: 858 649 3251
Facebook-f Linkedin-in