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Wayne, PA, Feb 22, 2010 - ValiMation abacusBPM is offering three Free Webinars on Paperless Validation in the Month of March, 2010.

Wayne, PA, Feb 3, 2010 - Novartis, Microsoft, ValiMation present: Managing Validation Life Cycle Sans Paper: A Working Model at the DIA Annual Meeting

Track:
Validation (VA)

Day & Time:
June 17, 10:30AM - 12:00PM

Level:
Intermediate

Session Title:
Managing Validation Life Cycle Sans Paper: A Working Model

Session Chair(s):
Nagesh J Nama
ValiMation, Inc.

Session Description:
This session demonstrates that paperless validation is not an oxymoron. A paperless validation plaftorm leverages web 2.0 technology to change the current paradigm. This platform can increase efficiencies while saving millions of dollars for the FDA regulated industry.

Objective:
Discuss the value of a paperless system as opposed to paper or "paper on glass", or how a paperless system places priority on managing good engineering practices (GEP) and processes; Examine how the new paperless platform can save cost while increasing efficiencies; Describe how the industry can leverage this platform to facilitate collaboration which is currently lacking; Explain how to convert mounds of information collected during validation efforts into knowledge.

Presentation(s) & Speaker(s):
Paperless Validation: A Real World Case Study
Jim McElroy
Technical Process Leader - Contract
Novartis Pharmaceutical Corporation

Building a Paperless Validation Platform Leveraging Web 2.0 Technologies
Nagesh J Nama
ValiMation, Inc.

Part 11 Compliance on the SharePoint Content Management and Collaboration Platform
Les Jordan
Chief Technology Strategist, Life Sciences
Microsoft Corporation

Click here for more info....

Automated Validation Lifecycle Management – A Working Model - By Novartis & abacusBPM (Webinar on May 13, 2010)

PDA Web Seminar
Date: May 13, 2010
Time: 1:00 p.m. – 2:30 p.m. ET
0.15 CEUs
PDA# 704
Registration Code:WEB10-8

Seminar Overview

This web seminar presents a platform that changes the status quo completely. The automated validation lifecycle management platform eliminates paper completely and changes the current paradigm. This platform increase efficiencies and thus while saving millions of dollars for the FDA regulated industry. Attendees will witness this paperless platform in action. This working model will:

Showcase a live demo.
Demonstrate the following use cases:
Asset Management: supports real-time “validation” status reporting.
Document Template Management: provides tools to build best practice templates.
Document Authoring: provides tools for authors so that they can focus on content instead of format.
Protocol Executions: supports paperless executions.
Traceability: supports automated traceability between documents.
Risk Analysis: supports automated risk assessments.
Project Management: supports embedded project management features.

Learning Objectives

At the completion of this seminar, you will be able to:

Discuss the value of a paperless system as opposed to paper or "paper on glass".
Showcase a platform that can deliver best practices efficiently at an enterprise level.
How the industry can leverage web 2.0 technologies that already exist in the enterprise to implement GAMP 5 or ASTM-E2500.
Examine how the new paperless platform that can save cost while increasing efficiencies.
How the industry can leverage this platform to facilitate collaboration which is currently lacking.

Please click here for details

Continuing Education Credits

PDA is approved by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Following full attendance, completion and submission of the appropriate evaluation form(s), certifi cates will be mailed within four to six weeks of the event. Continuing Education Units (CEUs) will be awarded as follows 0.15 CEUs for 1.5 hours per Web Seminar.

ACPE# 116-000-10-704-L04-P
0.15 CEUs

Managing Cleaning Validation & Assessments Sans Paper - A Case Study - By Novartis & abacusBPM (webinar on Oct 21, 2009)

Seminar Overview

This web seminar demonstrates Paperless Cleaning Validation and Assessments. This Paperless platform leverages web 2.0 technology to change the current paradigm. This platform can increase efficiencies while saving millions of dollars for the FDA regulated industry. Attendees will witness this paperless platform in action. The current fiscal state of the pharma industry coupled with FDA’s Quality By Design (QBD) initiatives makes it inevitable for the status quo to take the typewriter route. This web seminar will:

Showcase a live demo.
Include web based automated cleaning assessments, automated generation of protocols, online protocol executions – leveraging Microsoft’s .NET™ platform to eliminate paper completely.
Demonstrate that all involved personnel can focus on content, while smart technology can take care of implementing the business and compliance rules

Learning Objectives

At the completion of this seminar, you will be able to:

Discuss the value of an automated system to manage the entire cleaning validation lifecycle sans paper
Discuss the value of a paperless system as opposed to paper or "paper on glass". In other words, a paperless system places priority on managing good practices and processes
Examine how the new paperless platform can save cost while increasing efficiencies
Describe how the industry can leverage this platform to facilitate collaboration which is currently lacking
Identify how to convert mounds of information collected during validation efforts into knowledge
Describe how to implement standards that are typically buried in SOPs and policies

Click here for details:

Continuing Education Credits

ACPE PDA is approved by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Following full attendance, completion and submission of the appropriate evaluation form(s), certifi cates will be mailed within four to six weeks of the event. Continuing Education Units (CEUs) will be awarded as follows 0.15 CEUs for 1.5 hours per Web Seminar.

ACPE# 116-000-09-732-L04-P

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