Webinar Replays
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QUMAS DocCompliance and QUMAS Bulk Loader
Webinar Overview
One challenge that is faced by all life sciences companies is the management of bulk content. With the shift to migrating from paper paradigms to electronic, as well as the frequent engagements with external resources such as CROs and CMOs, the need for managing the importing and exporting of content to and from a controlled repository in a streamlined fashion becomes critical.
In this 45 minute presentation Patricia Santos Serrao RAC will discuss and demonstrate solutions for the following topics:
- Bulk Loading tools for manually importing bulk content
- Rules based approach to import automation; allowing your technology to do the work for you.
- Getting the most benefit out of your scanning solutions in managing controlled documents; producing agency compliant scanned output
Featured Speaker: Patricia Santos Serrao
Originally Aired as part of the QUMAS Client Webinar Series: May 6, 2008
QUMAS DocCompliance eCTD and Authoring Templates
Webinar Overview
The January 1, 2008 deadline for eCTD has come and gone, challenging more and more companies with making the changes that come when transitioning from paper or legacy format submissions to eCTD. The primary challenges revolve around managing not only the document lifecycle of individual submission documents but managing the submission lifecycle itself. The eCTD format is designed to enhance the full lifecycle of a submission, not just the individual application.
In this 45 minute presentation, Patricia Santos Serrao RAC, Manager of Global Regulatory Solutions at QUMAS, will discuss and demonstrate QUMAS solutions for the following topics:
- Implementing solutions for the authoring of eCTD compliant granular documents for all functional areas contributing to an eCTD
- Different approaches to implementing solutions for electronic records management as well as requirements for electronic signatures
- Tips and advice on configuring taxonomy, document types and streamlining the creation, authoring, reviewing and approving of documents
- Time saving tips on building your submissions to minimize workload as submission deadlines approach
Featured Speaker: Patricia Santos Serrao
Originally Aired as Part of the QUMAS Client Webinar Series: April 30, 2008
Streamlining Change Control in FDA & ISO Environments
Webinar Overview
In today's highly regulated life sciences environment, organizations face a myriad of regulations and regulators affecting all aspects of the enterprise. One area under increasing regulatory scrutiny is change control: specifically, the ability to manage deviations - both planned and unplanned - from the documented way of operating. Changes can occur for all kinds of reasons, including the introduction of new equipment, process improvements, consolidation of facilities to achieve cost efficiencies, or the development of new methods based on scientific discovery.
In this session, Warren Perry, senior compliance advisor at QUMAS, discusses why it is vital for organizations to review the challenges affecting current environments; implement a cohesive, closed-loop approach to automating change management; explore integration considerations with key business and product lifecycle systems; and highlight real-world workflow examples spanning the organization and extending throughout the product lifecycle.
Featured Speaker: Warren Perry, Senior compliance advisor in the life sciences practice at QUMAS
Originally Aired: Wednesday, April 23, 2008
Ensuring Proactive CAPA Management
Will your CAPA solution stand up to regulatory inquiry?
Webinar Overview
Up to 50% of the top ten FDA 483 items are directly related to CAPA (Corrective Actions Preventive Actions). How can you ensure that you have a proactive CAPA management solution in place, and that you are addressing issues that occur in your organization in a way that will meet with regulatory approval?
In this session, Caoimhe Kiely, regulatory advisor at QUMAS, discusses the key considerations for managing corrective and preventive actions; best practices for automating CAPA workflows and processes; and, presents a client case study.
This 45-minute presentation focuses on what a good CAPA management system should include:
- Forms for logging issues that occur across the organization, so that investigations can lead to root cause analysis, severity ratings that initiate priority workflows, and flags and alerts that notify relevant individuals of possible material weaknesses or patient safety concerns
- Corrective or preventive action plans that are automatically routed to employees
- Updated policies, procedures and SOPs based on the outcome of the corrective actions
- Point in time reporting for management or for regulators who are investigating a particular issue, and dashboards for executives
- CAPA linked to risk management
Featured Speaker: Caoimhe Kiely, Regulatory advisor in the life sciences practice at QUMAS
Originally Aired: Wednesday, Feb. 20, 2008
QUMAS 'Upgrade Now' Client Webinar*
Webinar Overview
This client webinar provides a detailed overview of the QUMAS 'Upgrade Now' program.
Upgrade Now allows QUMAS clients to leverage usability, performance, and support enhancements that are only available in QUMAS DocCompliance 4.01. This packaged offering is designed to make the transition as easy as possible. The focus of this 40 minute presentation is on the various elements of the program, the resulting client benefits and customer experiences to-date.
*This webinar replay is available to QUMAS clients and partners only.
Featured Speaker: Sean Winslow, Director, Global Professional Services, QUMAS
Originally Aired: Thursday, December 13, 2007
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
Establishing a Policies and Procedures System for a Successful Regulatory Review
Webinar Overview
Compliance professionals agree policies and procedures are the cornerstone of any sound compliance program. Yet, many organizations mistakenly believe their Web-based policies and procedures intranet will suffice – only to have it fail when they need it most – during an audit. If your compliance operations are limited to policies and procedures that are scattered around the organization within isolated document repositories or Web-based intranets, can you ensure a proactive and robust regulatory defense?
This 45-minute presentation will focus on how to:
- Replace existing manual and fragmented policies and procedures systems
- Address regulations such as 38a-1; MiFID; NASD reg. 3013
- Build a proactive regulatory defense
- View your policies and procedures the way a regulator does
- Automate the creation, distribution and training of new and updated policies and procedures
- Document to auditors that an issue was an isolated event rather than a systemic problem with your organization
- And, why your current system may need to be upgraded.
Featured Speaker:
Caoimhe Lynch, Chief Strategy Officer, QUMAS
Originally Aired: Thursday August 23, 2007
Neurogen Automates Content and Submissions Management Expediting the New Drug Application Process with QUMAS R&D Solution
Webinar Overview
Life sciences organizations today are challenged to maintain product quality, productivity, ROI and compliance. To be competitive, biopharmaceutical companies must streamline their product lifecycles, including IND and NDA approvals, as well as validation of the production process.
In this webinar, hear how Neurogen Corporation (NASDAQ: NRGN) meets these challenges using the QUMAS R&D Solution™, an all-inclusive content and publishing system, for its content management needs for Nonclinical, Clinical, CMC, Safety, Quality and Regulatory groups.
This 25-minute presentation focuses on the following topics:
- Evolving paper-based and decentralized document filing systems.
- What to look for in an automated solution to expedite regulatory filings.
- Benefits of a fully integrated content management and submission management solution.
- Why a secure and controlled document collaboration system is an essential requirement.
- Expectations for higher quality and more efficient results for today and tomorrow.
Featured Speakers:
Joanne Malia, Computer Systems Validation Manager, Neurogen
Al Starbard, Sr. Director, Information Technology, Neurogen
Patricia Santos Serrao, RAC, Regulatory Advisor, QUMAS
Originally Aired: June 5, 2007
QUMAS R&D Solution
Webinar Overview
The QUMAS R&D Solution — an effective R&D strategy in a box — assists Life Science companies in expediting the new drug application process with better quality submissions, fewer iterations and shorter review and approval cycles.
This 45 minute webinar focuses on the following topics:
- Document management - keeping the needs of each functional area of R&D in mind (Clinical, Non-Clinical, CMC, RA)
- Managing all of your publishing needs with one publishing tool
- Benefits of integrated content management and submission management solutions
- What to look for in content management and submission management integrations
- The needs of document collaboration with internal and external authors
- Intelligent Authoring Templates: Help your authors focus more on content and less on guidances
Featured Speaker: Patricia Santos Serrao, RAC, Regulatory Advisor, QUMAS
Originally Aired: Thursday, February 22, 2007
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QUMAS Express — the latest approach to a 'view only' client.
Webinar Overview
This webinar introduces QUMAS Express, the background and requirements for the product, outlines the product Features and Benefits, and gives an overview of the product functionality and interface.
QUMAS Express enables "business or non-technical" users of QUMAS DocCompliance to view documents with ease, delivering only the functionality needed to view a document and its associated information, such as properties. Users can also mark documents as Read and Understood, search for documents and print documents.
QUMAS Express also enables members of Workflow Approval or Release Approval Panels to approve or disapprove workflows - only users with the relevant roles and permissions will be presented with this functionality. QUMAS Express is available for DocCompliance Versions 3.3 and 4.0.
Featured Speaker: Caoimhe Lynch, Strategy Officer, QUMAS
Originally Aired: Thursday, January, 11, 2007
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Strategies Pharma Should Use To Manage Risk And Compliance
Webinar Overview
Pharmaceutical companies are challenged with managing a wide array of risks alongside meeting a complex web of regulatory obligations. From litigation risks, R&D forecasting, intellectual property protection, laboratory practices, brand protection, manufacturing systems validation, marketing requirements, clinical trials compliance and privacy - the list of risks and compliance requirements is daunting. This executive webinar looks at the unique risks and compliance obligations that pharma companies face compared to other industries and the best practices for leveraging technology to manage risk and comply with regulations within pharma.
Originally Aired: Wednesday, June 21, 2006
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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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