1:00 p.m. – 2:30 p.m. ET
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.
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
Speaker
Jim McElroy, Manager, Compliance Engineering,Novartis
Jim McElroy is a Manager, Compliance Engineering at Novartis. He has over 20 years of experience in the pharmaceutical industry. He has held various positions: Research Scientist, Process Technologist, Senior Scientist, and Compliance Manager. In the last few years, he has led various efforts to automate compliance business processes leveraging latest Microsoft technologies. He has recently managed the qualification of a 60+ million dollar facility upgrade. He has implemented ISPE guidelines and streamlined several quality functions within the Novartis organization. These changes have resulted in tremendous savings. He has frequently interacted with the FDA, internal auditors and external auditors. His experience in dealing with regulatory organizations has resulted in successful audits. He has implemented an electronic document management system (using Microsoft SharePoint as a platform). He is spearheaded a project to implement a Paperless Cleaning Validation application using Sharepoint 2007. He is developing a paperless system that will give end-users a rich environment to manage changes and ensure compliance with safety and GMP practices
Nagesh Nama, President,ValiMation, Inc
Nagesh Nama has worked with the pharmaceutical industry for over 16 years providing services and managing turnkey projects in the areas of software solutions, business process automation (BPA), validation and GxP compliance. Over the past few years, Mr. Nama has developed a highly successful methodology to design FDA compliant Business Process Management (BPM) solutions/products and resolve technology compliance issues in the industry. He is involved in task groups and frequently speaks at many computer validation, automation and technology conferences. He works with ValiMation abacusBPM’s clients to develop corporate wide strategies for BPM, 21 CFR Part 11, risk based validation and compliance, computer validation and IT infrastructure qualifications. Mr. Nama has a Master’s in Engineering from the University of Massachusetts at Amherst.
Registration contact
Leon Lewis
Assistant Manager, Programs and Web Seminars
Tel: +1 (301) 656-5900 ext. 149
Fax: +1 (301) 986-1093
Email: lewis@pda.org
Jason E. Brown
Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email:
brown@pda.org