Thursday February 23rd, 2012
13:30 PM - 17:30 PM
Thermo Fisher Scientific
St Georges Court
Hanover Business Park
Altrincham
Cheshire
WA14 5TP
NextDocs and Thermo Fisher Scientific invite you to a half-day workshop covering the hot topics of a fully integrated Laboratory Information Management System (LIMS), Document Management System (DMS) and enterprise environment - providing seamless communication between lab systems that contain data, documentation and reports with floor operations.
Comprehensive regulatory compliance is achieved through intelligent data management. Secure and traceable sample data, specifications, SOPs, instruments and resource management, calibration and training records, Certificate of Analysis, etc. All of this information and documentation needs to be maintained in an integrated secure system which delivers a complete audit trail, eSignatures, and authentication – on demand.
By attending you will learn:
- How to meet the increasing demands for regulatory compliance so that your organization can mitigate legal risks, improve corporate governance, and maintain the documentation that fully demonstrates regulatory compliance
- How to improve business and operational effectiveness to adapt and meet changing regulations such as 21 CFR Part 11, EPA, FDA, SEC Rules, or ISO Certification
- How to reduce the amount of time spent on manually generating reports, retrieving paper documents and aggregating information required by regulators – and realize hidden cost savings
- How to streamline and simplify reporting between your lab and enterprise systems
- How an integrated informatics solution simplified water, environmental and pharmaceutical regulatory compliance and transformed process efficiencies at Nova Biologicals : http://www.nextdocs.com/en-us/Case%20Studies/FINAL%20NOVA-CS.pdf
- How to maximize your informatics investments and better support critical management decisions
Session Agenda:
| Time |
Topic |
13:30 – 14:00 |
Registration |
14:00 – 14:15 |
Introduction : Overview of LIMS and Laboratory Integration
(Bob Poole, Thermo Fisher Scientific) |
14:15 – 14:30 |
Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Orang Gholikhani, NextDocs)
- Company and Strategy Overview
- Document & Quality Management System
- Regulatory Submission, SOP, Clinical Trial
- Interoperability & Integration
|
14:45 - 15:15 |
Why should a Document Management System be integrated into a LIMS? (Christophe Benninghoff, NextDocs et Cristina Roman, Thermo Fisher Scientific)
- Nova Biological Case Study
- Integration and its day to day benefits
|
|
|
15:15 – 15:30 |
Coffee Break |
15:30 - 16:15 |
Demonstration of a Document Management System for Quality Document (SOP) within a regulated environment. (Christophe Benninghoff, NextDocs)
- Document Creation
- Optimizing Document diffusion
- Make user training easy
|
16:15-17:00 |
Demonstration of Thermo Scientific SampleManager LIMS.(Cristina Roman, Thermo Fisher Scientific)
- Sample Management
- Features required by ISO17025
- User training
- Device Maintenance
- Store Management
|
17:00 - 17:30 |
Q&A |
Thursday February 23rd, 2012
13:30 PM - 17:30 PM
Thermo Fisher Scientific
St Georges Court
Hanover Business Park
Altrincham
Cheshire
WA14 5TP
Register:
For more information and support, please contact :
Nicola Gardner nicola.gardner@thermofisher.com phone : 0161 942 3047