On-Demand Webinars Archive
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MyQUMAS: Empowering Users Across the Organization
Webinar Overview
Across all organizations today, a major driver is the ability to do more with existing resources by enabling employees to work more efficiently. Part of that drive is a single, integrated platform for Compliance and Risk delivered in one common interface that allows stakeholders in the company to make risk-based decisions, access integrated workflow processes and have visibility into an effective closed-loop process through that common interface.
MyQUMAS is a single interface that delivers a zero training User Interface for viewing, printing and completing a large number of tasks that have been routed to the end user. By providing access to all Compliance related areas of the organization, from both QUMAS and third parties, in a single solution, productivity is greatly increased.
During this 45 minute webinar, QUMAS Compliance Advisor, Warren Perry, will demonstrate the MyQUMAS solution and highlight the benefits it provides. Among others, these benefits include:
- Proactive regulatory defense
- Improved quality and manufacturing operations
- Reduced costs of compliance
- Increased customer satisfaction
- Ability to adapt quickly to manufacturing changes
- Reduced time to market
Featured Speaker: Warren Perry, Compliance Advisor, QUMAS
Originally Aired as Part of the QUMAS Client Webinar Series: May 22, 2008
Managing the Successful Transition to eCTD
Webinar Overview
Starting January 1, 2008, the FDA will require that all electronic submissions be filed in an eCTD format. Companies may also file in paper using CTD format for organizing submissions into modules and volumes.
Patricia Santos-Serrão, a regulatory advisor in the life sciences practice at QUMAS, discusses the common challenges life sciences companies and regulatory affairs groups face when moving from paper and legacy submissions systems to an electronic document management system.
This 35-minute presentation focuses on:
- What the impact of the January 1, 2008 deadlines for eCTD will be on life sciences companies and their processes.
- How to support submission requirements in an efficient and effective manner while significantly decreasing workloads.
- The top 10 questions each company should ask in order to evaluate their readiness to proceed with electronic submissions.
- Understanding different approaches to implementing solutions for electronic records management as well as requirements for electronic signatures.
- Selecting and implementing solutions for preparing functional areas to author documents in eCTD format.
- Case study of a successful transition plan that includes milestones, risks, mitigation strategies and learning outcomes.
Featured Speaker: Patricia Santos Serrao, RAC, Regulatory Advisor, QUMAS
Originally Aired: Thursday, December 6, 2007
QUMAS ProcessCompliance 2.5 Overview*
Webinar Overview
The webinar focuses on new features and benefits of QUMAS ProcessCompliance 2.5 including:
- New UI elements including enhanced CSS support that make it easier to build forms and create new layouts
- Integration with QUMAS Express
- Support for Oracle 10; Crystal 11; Java 1.6
- Import/export schema
- Events Management
QUMAS ProcessCompliance™ provides reliable workflow management and control, allowing an organization to map the system to its own specific processes and enhance both regulatory compliance and overall operational efficiency. The solution is the third generation of the ProcessCompliance solution and incorporates suggestions from many users in each release. ProcessCompliance offers the best combination of industry standard business rules handling, configurable forms design, fully integrated data dictionary and highly scalable workflow – all without a single line of customer specific code. Integrated as part of the QUMAS Compliance Suite, ProcessCompliance delivers complete and consistent compliance processes across the enterprise.
Featured Speaker: Cyril Walsh, Solutions Consultant, QUMAS
Originally Aired: Tuesday, September 18, 2007
*This webinar is restricted to existing QUMAS customers and partners only. If you would like to receive information regarding QUMAS ProcessCompliance 2.5 please email info@qumas.com
Process Management; An Integrated Approach to Change Control
Webinar Overview
A closed-loop system to manage change control, from validated systems to complete Product Lifecycle is critical in today's highly regulated workplace. The ability to provide reliable workflow management and control, but yet allow each organization to map the system to its own specific processes will enhance both regulatory compliance and overall operational efficiency. As Process and Product Improvement Initiatives such as Six Sigma and ISO standards become more common-place across global organizations, the need for enterprise-wide systems that integrate all aspects of process management become vital to the success of any project. An integrated approach to Process Management that allows for a single point of access to both process workflows and controlled documents in the same application is key to effective change control.
Originally Aired: Wednesday, June 7, 2006
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Content Management in Today's Global Enterprise; The Virtual World of Collaboration
Webinar Overview
This executive webinar focused on content management across the enterprise. As global environments become more common-place, with authors, editors and reviewers working from remote locations, the ability to access the correct version of any document, whether draft or final is critical. Controlled, compliant content is created and consumed by multiple departments both within the organization and outside, and the need to maintain secure access to your company's intellectual property has never been greater. Whether it is Finance, Legal, HR, Sales and Marketing, Manufacturing, QA or RA, outside partners or vendors such as CRO's, secure, and controlled access to your content is one of the biggest challenges any organization faces today.
Originally Aired: Thursday, May 25th, 2006
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