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Orang Gholikhani How to transfer a paper based Deviation Management to a GxP-compliant Quality Management System based on SharePoint 2010
How to transfer a paper based Deviation Management to a GxP-compliant Quality Management System based on SharePoint 2010
Thursday 29 March, 2012 Leipzig, DE Complimentary Half Day Workshop
NextDocs and IDT Biologika invite you to a half-day workshop covering the hot topics of a fully integrated Quality Management System (eQMS) and enterprise environment.
Effective management of deviations is one of the most important requirements for the pharmaceutical industry and regular monitored by authority inspections. Modern Quality Management Systems (eQMS) allow defining a lean workflow based process. But the real challenge is to find out the right balance between own efficiency and the requirements of the customers.
You will leave with a clear understanding of how IDT Biologika has coped with this challenge within the project and the go-live phase and how SharePoint 2010 can be used as a unified platform for all your validated quality and document management requirements in a compliant manner with 21 CFR Part 11.
By attending you will:
• Hear about a successful project where IDT Biologika optimized the company’s Quality process by implementing NextDocs and Microsoft SharePoint technologies.
• Have an overview of SharePoint 2010 in the context of managing quality processes in a life sciences environment
• Gain insight into Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences.
• See a demonstration of a complete Deviation >> CAPA cycle, including initial preparation, notifications to the correct parties and generation of a resulting corrective action.
Experts from the leading service and solution providers will share their experience through presentations and live demos
Session Agenda:
Time Topic
13:30 – 14:00 Registration
14:00 – 14:15 Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Romuald Braun, NextDocs)
• Company and Strategy Overview
• Document & Quality Management System
• Regulatory Submission, SOP, Clinical Trial
• Interoperability & Integration
14:15 – 15:15 Real example of a Quality System implementation (Dr. Jörg Köhler, IDT Biologika)
An overview of how to transfer a paper based Deviation Management to a GxP-compliant electronic Quality Management System inside a CMO-customer-relationship
• Conception and design
• Migration, Implementation
• Lesson learned
15 :15 – 15 :30 Coffee break
15 :30 – 17 :00 Demonstration of NextDocs Quality Management System (Richard Barnfield, NextDocs)
• Deviation
17:00 - 17:30 Q&A
Thursday 29 March 2012
13:30 - 17:30
Registration :
The Westin Leipzig
Gerberstraße 15 • D-04105 Leipzig
For more information and support, please contact :
Orang Gholikhani phone : +33 601168839
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Orang Gholikhani Who would join us in ShareFEST 2012?
ShareFest is the premier Microsoft SharePoint Conference for Life Sciences. Organized and hosted by NextDocs, ShareFEST 2012 will be held on April 19-20, in Philadelphia, PA. The conference attracts several hundred attendees from pharmaceutical companies, device manufacturers, biotechs and service providers from around the world
ShareFEST provides a two day forum for information sharing and discussion on how Microsoft SharePoint solutions are helping address the content/records management and collaboration challenges that are facing the industry.
Over 25 sessions focused on:
•Quality Management
•Collaborative Clinical Trials
•Regulatory & e-Submissions
•Corporate Solutions
•Records Management & e-Archiving
•Upgrade and Migration Strategies
•IT Methodologies and Validation
•Integrating Complementary Technologies
Orang Gholikhani Konferenz Regulatorisches (e)Dokumentenmanagement Pharma
Dear all,
We would be present at Konferenz Regulatorisches (e)Dokumentenmanagement Pharma
30 Januar - 01 Februar 2012, Pullman Berlin Schweizerhof, Berlin
We would be happy meeting you at our booth.
Orang Gholikhani
Orang Gholikhani Automating Data Management while Facilitating Regulatory Compliance
Automating Data Management while Facilitating Regulatory Compliance
Nova Biologicals implements an integrated water, environmental and pharma LIMS/DMS
Paul Pearce, Ph.D., Colin Thurston
Orang Gholikhani NextDocs Hiring : Professional Services Technical Consultants – Germany, France, Sweden, Denmark, UK
Professional Services Technical Consultants – Germany, France, Sweden, Denmark UK
Page Content
We have IMMEDIATE OPPORTUNITIES for both Senior Technical Implementation Consultants and Technical Implementation Consultants for our European market. Our Consultants will be working in small project teams, and are responsible for implementing NextDocs systems with Clients throughout Europe. Work will be carried out at home, on NextDocs premises and also at customer sites. Travel expectations are European based and approximately 25 – 50% of the time.
The role would suit an individual with between 2 and 5 years consulting experience, ideally experienced in Microsoft technologies and/or Document and Quality Management software. Experience of working in the Pharmaceutical/Life Sciences industries would be advantageous, but is not essential.
Our consultants are very independent and are used to working in close dialogue with clients, in a fast-paced environment. Therefore, the ability to communicate fluently in English is essential, as is the ability to manage your own time and commitments accordingly.
Typical Project Role Activities:
•MS InfoPath: Creation and re-configuration of forms and development of form logic using .Net C#. Definition of data connections, deployment of administrator approved forms and mapping InfoPath fields to SharePoint site columns.
•MS SharePoint: Installation, Site creation and migration, List definitions, Content Type definitions, Security configuration.
•NextDocs Application: NextDocs application installation and configuration, SQL Server analysis (structure, SQL queries, etc.). Design of complex workflows to implement business processes (SharePoint Workflow Foundation with Nintex).
•Infrastructure: Server Installations, Windows Server Maintenance, SharePoint Installations and understanding of Active Directory concepts
•Electronic Document Management: Consulting expertise in Electronic Document & Form Management, Versioning, Lifecycles and Workflows, Electronic Signatures, Audit Trail, Compliance, Systems Validation (including involvement in preparation and execution of IQ, OQ, PQ), Digital Signatures and PKI, Data Migration, 21 CFR Part 11 and project documentation tasks.
Position Requirements:
• Computer Science degree or equivalent work experience.
• Programming experience on C# / .Net / ASPX / SQL Server.
• Experience of Server Installations, Windows Server Maintenance, understanding of AD concepts
• Fluent in English with excellent communication skills.
Additional Preferred Skills:
• Experience in the Pharmaceutical/Life Science industries.
• Experience implementing document and/or quality management systems.
• Knowledge of Microsoft SharePoint Server
• Additional languages would be a bonus, particularly German and French.
This is an excellent opportunity to join an expanding company and will suit someone looking for career progression. This position is compensated with great salary and benefits!–-Germany,-France,-Sweden,-Denmark,-UK.aspx
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