On-Demand Webinars For All Audiences
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AMR Research & QUMAS Webinar, Supply Chain Compliance
How Firms Can Ensure Regulatory Compliance Throughout the Supply Chain
Webinar Overview
Join AMR Research and QUMAS for a complimentary webinar focused on regulatory compliance throughout the supply chain!
During this webinar, Roddy Martin, Vice President, Research Fellow at AMR Research, reviews product supply strategies and steps to achieving supply network operational excellence and Ken Hayward, CTO at QUMAS discusses how to ensure regulatory compliance throughout the supply chain.
In discussing regulatory compliance across the supply chain, the following topics are explored:
- Reducing supply chain buffers by eliminating root causes of exceptions
- Ensuring complete adoption of CAPA commitments through consistent change control
- Improving compliance decision making through the linkage of key supply chain systems and data
- Clear communications through statistical dash boards and KPIs
- Reducing change implementation costs through inter site and above site processes
- Improving compliance oversight through broad availability of current and historical state
Featured Speakers:
Roddy Martin - Vice President, Research Fellow, AMR Research, Inc.
As Vice President, Research Fellow, Roddy is responsible for managing the company's value chain analysis and research across all industries. Roddy researches a variety of topics including systems support to operations, IT, and manufacturing strategy. Roddy was a key contributor in the development of AMR Research's demand-driven supply chain model. His research brings together the strategic, business, and organizational issues faced when implementing IT and enterprise architectures, processes, and applications across the value chain. Roddy has over 27 years of experience, most recently as an executive at South African Breweries (SAB), one of the three largest brewers in the world.
Ken Hayward - Chief Technology Officer, QUMAS
Ken Hayward has over 20 years experience in the regulated software and document management industries. With extensive knowledge of compliance related technologies and the business problems they solve, Ken has designed software systems for regulated companies since the early 1980s. Originally a client before joining QUMAS in 2002, Ken worked with the London International Group, Kinesis Systems and PriceWaterHouse Coopers.
Originally aired January 28, 2010
QUMAS Biotechnology Package Overview
Webinar Overview
It's not surprising that in today's economy, companies are actively cutting costs and looking to improve efficiency. Nowhere is that more true than in the emerging biotech industry. Emerging biotech have the need to do more with less while still being competitive with their larger competitors. For some of these companies the thought of investing in a necessary Electronic Document Management System (EDMS) is both overwhelming as well as financially concerning. Fears of the amount of investment both in resources and financially can often lead companies to risk compliance and reduced efficiency.
This session discusses:
- The business challenges that the biotech industry is facing with regulatory and compliance requirements
- Industry best practice configurations of an EDMS for the biotech industry
- The functionality needed in an EDMS that can help your organization to not only be compliant but more efficient
Featured Speaker:
Patricia Santos-Serrão,RAC, Manager, Global Regulatory Solutions, QUMAS
Length:
45 minutes
Originally aired November 11th, 2009
QUMAS eCTD Health Check: What is your eCTD readiness?
Webinar Overview
With the new EMEA guidelines regarding centralized procedure submissions in electronic format taking effect from January 1st 2010, many organizations are concerned about their eCTD readiness. Whether you are currently paper-based, have started the transition to an electronic document management process, or are fully up and running with an EDMS, one thing is certain, transitioning to an electronic submission process can at times feel overwhelming. Questions around how people and processes will be impacted and what role technology can have in the transition are endless. QUMAS Professional Services offers an eCTD Health Check to help you assess your readiness for the eCTD or to help kick-start your readiness initiatives. The QUMAS eCTD Advisory team (lead by an RAC certified Regulatory Advisor) conducts a detailed risk assessment, including a technology, process, and personnel gap analysis. Our team will develop an eCTD readiness roadmap that defines critical milestones, KPI's, and performance objectives to drive your eCTD initiative. We will also develop the internal processes for the delivery of quality submissions to regulatory agencies. We will show you how best to utilize existing systems and tools to put you on the path to "going electronic" with your regulatory agency applications.
This 30 minute webinar outlines the QUMAS eCTD Health Check and discusses ways to access your organizations eCTD readiness.
Featured Speaker:
Patricia Santos-Serrão,RAC, Manager Global Regulatory Solutions, QUMAS
Length:
28 minutes
Originally aired December 8th, 2009
Buy Versus Build When Managing Regulatory Compliance
Webinar Overview
This IDC Health Insights and QUMAS webinar focuses on whether Biotechnology firms should buy an off-the-shelf solution or build a custom solution for regulatory compliance and submissions. The pros and cons of buying vs. building a solution as well as the key challenges facing Biotechnology firms are reviewed. Findings from a recent IDC study on the current purchasing trends for software applications are also shared.
The webinar focuses on the following topics:
- The external forces transforming the life sciences industry
- Key factors driving buy and build decisions
- Current purchasing patterns for enterprise software applications
- Key requirements for a world-class regulatory compliance and submission solution
- How small and midsize Biotechnology firms can implement the same best practices currently in place at Tier 1 Pharmas
Featured Speakers:
Dr. Alan Louie
Research Director at IDC Health Insights
Dr. Louie spearheads the company's research covering innovation and best practices in pharmaceutical R&D and personalized medicine with an emphasis on innovation in clinical development. A recognized thought leader in both the health and life sciences industries, Dr. Louie is a frequently sought-after speaker at top industry events, including Bio-IT World, DIA and the Drug Discovery Technology World Congress. He has authored more than 80 reports on innovation in the life sciences during his tenure at IDC. Dr. Louie brings more than 24 years of technical, product development, and business consulting experience from the diagnostics and biotechnology industries.
Susan Houde
Manager, Quality Assurance, Millennium, The Takeda Oncology Company
Susan Houde is Manager, Corporate Quality Assurance Documentation for Millennium, The Takeda Oncology Company. She played an integral role in the original implementation of (e)DocCompliance at Millennium in August 2004 and again with the upgrade to DocCompliance 4.01 in 2007. Millennium is currently working on implementing MyQUMAS and QUMAS Enterprise Scanning along with an upgrade to 4.2. Susan's role includes managing DocCompliance for controlled documents, along with assisting in managing the day-to-day activities of a very busy Corporate QA Documentation team. Millennium Quality is investigating steps to initiate a Records Management solution, in which Susan will participate. Susan has over 18 years experience within the Quality/Documentation field.
Cyril Walsh, Senior Solutions Consultant, QUMAS
Length:
48 minutes
Originally aired October 29th, 2009
Submission Document Lifecycle: The Life of a Document Before Submission
Webinar Overview
Are you ready to take the step towards going electronic with your submissions but are not sure what you should be doing with your documents even before putting them in a submission?
Perhaps you are shopping for an Electronic Document Management System (EDMS) and/or publishing solution, or you may already have them and are not sure what steps are handled by the tools and what is handled by processes?
You have probably heard the term "submission ready documents" but are not quite sure what that means?
During this 50 minute webinar, Murtuza Vasowalla, Director, Global Solutions Consulting at QUMAS, answers each of these questions and covers best practices in the use of metadata, document templates and formatting technique to consider for supporting global submissions, workflows for document reviewing and approval as well as rendering of documents to PDF. These best practices will help reduce or eliminate post approval editing of documents to have them ready for publishing. Areas to be covered include:
- Document Types and Document Templates
- Document Type / Template Mapping
- Document Types and Extended Attributes
- Document Authoring & Collaboration
- Rendering (Bookmarks / Hyperlinks)
Featured Speakers:
Murtuza Vasowalla, Director, Global Solutions Consulting, QUMAS
Length:
51 minutes
Originally aired August 19th, 2009
QUMAS Compliance Solution
A Complete Guide to Document and Quality Management
Webinar Overview
In this session, Cyril Walsh, Senior Solutions Consultant at QUMAS, presents an overview of the QUMAS Compliance Solution. Cyril will demonstrate the key features of an enterprise compliance solution for Life Sciences organizations.
This 60-minute webinar focuses on the key components of MyQUMAS, the QUMAS Document Management and Quality Management solution, including:
Document Control
- Ability to view, search and print documents from one central portal
- Ability to review and edit SOPs in controlled environments
- Document approval by role-based users
- Ability to provide Read & Understood Training on authorized documents
- Compliance with 21CFR Part 11 (electronic signatures )
Quality Process Control
- Creating a new Change Control Instance
- Utilizing Pre-configured Workflows to allocate tasks
- Electronic Forms Management for Data Capture
- Business Rule Generated Task Allocation for Escalations and Workflow Management
'Compliance Intelligence' Dashboard
- Management of Reports including both document and process tasks
- Trends, workflow and task status reports
Featured Speakers:
Cyril Wash, Senior Solutions Consultant, QUMAS
Length:
60 minutes
Originally aired July 23rd, 2009
Compliance Week Webinar
Compliance Case Study: Leverage Best Practices to Optimize Your Compliance Management Program
Webinar Overview
The cornerstone of a successful compliance operation is the effective management of policies and procedures. With every new or updated regulation, a significant burden is placed on those who manage policies and procedures due to the impact on significant amounts of content from disparate functional groups.
Join us for a live webcast to hear how Lantheus Medical Imaging implemented an enterprise-wide document management program to manage a wide variety of content including policies, directives, protocols, records, regulatory submissions, and SOPs to name but a few. Joined by experts from Thomson Reuters and QUMAS, we will explore:
- The current market trends for compliance
- The importance of policy management
- What a mature compliance program will look like
- Best practices from Lantheus Medical Imaging to successfully implement a compliance initiative
- The role technology plays in helping companies establish a sustainable compliance program
Featured Speakers:
Bruce McCuaig, Vice President, Risk and Compliance, Paisley
Murtuza Vasowalla, Director of Global Solutions Consulting, QUMAS
Mark Weber, Manager, Manufacturing and Document Mgmt. IT Systems, Lantheus Medical Imaging
Length:
60 minutes
Originally aired July 16th, 2009
eRegulatory Submissions - A Complete Lifecycle Tutorial
Webinar Overview
In an industry shaped by new regulations, global competition, and high market expectations, successful Life Sciences companies must bring new products to market faster than ever. Effectively managing the lifecycle of your submissions, and being prepared to handle any type of application that the regulators require, is critical to a firm's success. In this webinar Life Science companies learn how to in expedite their marketing application process with better quality submissions, fewer iterations, and shorter review and approval cycles.
This 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)
- Effectively managing all of your publishing needs (legacy, paper, eCTD, CTD, medical device, and non-CTD regions)
- Benefits of integrating content management and submission management solutions
- How internal and external authors can collaborate and review documents more efficiently
- How to shorten your approval cycles
- Help your authors focus more on content and less on guidances with Intelligent Authoring Templates
This webinar is aimed at Life Sciences executives working in Regulatory Affairs, Clinical, Nonclinical, and Quality departments.
Featured Speakers:
Patricia Santos-Serrão, RAC, Manager Global Regulatory Solutions, QUMAS
Warren Perry, Director of eRegulatory Strategies, EXTEDO
Length:
58 minutes
Originally aired June 10th, 2009
The Sounds of Compliance - Shredding Master Documents
Webinar Overview
Dr. Joerg Stueben, Business Project Manager IDEA for Controlled Documents, Boehringer Ingelheim, presents "The Sounds of Compliance - Shredding Master Documents".
Dr. Stueben gives an interesting account of the initiative by a number of German Pharmaceutical companies to form a working group to determine if paper originals of master documents needed to be retained. They came to some interesting conclusions, and after discussion with the regulatory agencies Boehringer Ingelheim decided to take the innovative step of destroying paper master documents. As part of this initiative, Boehringer Ingelheim is employing the QUMAS Scanning Solution to ensure electronic control of all masters before destruction. Ken Hayward, CTO QUMAS, provides a brief overview of this QUMAS Scanning Solution in relation to the QUMAS eDMS, QUMAS DocCompliance.
View the Scanning Solution Product Brief
Featured Speakers:
Dr. Joerg Stueben
Business Project Manager for IDEA for Controlled Documents
Boehringer Ingelheim GmbH
Ken Hayward, CTO, QUMAS
Length:
44 minutes
Originally aired June 4th, 2009
AMR Research and QUMAS Present Change Control Management Best Practices
Webinar Overview
Change is a key process for all life sciences organizations. Do you know what a good change control process should include? Can you ensure that all of your facilities manage change cohesively? How do you report on change to your shareholders and to regulators?
During this 60 minute webinar, Wayne McDonnell, Research Director, AMR Research reviews effective change management strategies as well as the potential impacts of ineffective change management practices. Cyril Walsh, Senior Solutions Consultant, QUMAS advises of key approaches to change management, complex or simple, and provides guidelines on best practices, while Leo Zwijns, IT Director Quality and Compliance Applications at a top-10 pharmaceutical company, shares his experience of implementing a multi-site change management solution across global facilities.
The webinar focuses on what a good change control system should include:
- Forms for tracking the change control, capturing the details of the impacted areas, the decision flow, and departments/sites involved
- Tracking the change through the phases: Initiation, Impact Assessment, Evaluation, Execution, Implementation and Closure
- Updated policies, procedures and SOPs based on the outcome of the change control
- Point-in-time reporting for management or for change owners who are responsible for the change, and dashboards for executives
Featured Speakers:
- Wayne McDonnell, Research Director, AMR Research
- Leo Zwijns, IT Director Quality and Compliance Applications at a Top-10 Pharmaceutical Company
- Cyril Walsh, Senior Solutions Consultant, QUMAS
Length:
53 minutes
Originally aired April 14th, 2009
QUMAS eCTD Health Check: What is your eCTD readiness? (2008)
Webinar Overview
Whether you are currently paper-based, have started the transition to an electronic document management process, or are fully up and running with an EDMS, one thing is certain, transitioning to an electronic submission process can at times feel overwhelming. Questions around how people and processes will be impacted and what role technology can have in the transition are endless. QUMAS Professional Services offers an eCTD Health Check to help you assess your readiness for the eCTD or to help kick-start your readiness initiatives. The QUMAS eCTD Advisory team (lead by an RAC certified Regulatory Advisor) conducts a detailed risk assessment, including a technology, process, and personnel gap analysis. Our team will develop an eCTD readiness roadmap that defines critical milestones, KPI's, and performance objectives to drive your eCTD initiative. We will also develop the internal processes for the delivery of quality submissions to regulatory agencies. We will show you how best to utilize existing systems and tools to put you on the path to "going electronic" with your regulatory agency applications.
Featured Speaker:
Patricia Santos Serrao, RAC, Manager Global Regulatory Solutions, QUMAS
Length:
28 minutes
Originally Aired: November 20, 2008
Implementing an Electronic Quality Management System? : Key Items You Should Consider
Webinar Overview
In this session, Cyril Walsh, Solutions Consultant at QUMAS, discusses the key considerations for implementing an electronic Content Management and Process Management solution. Cyril takes a look at the business and compliance challenges faced by the Quality department. This includes the rising cost of compliance as well as the compliance risks the quality department needs to address in order to meet their 21 CFR part 11 requirements.
This 45-minute presentation focuses on what a good Content Management and Process Management QMS solution should include:
- Ability to author and review SOPs in virtual environments
- Document approval by internal/external users
- Web-based collaborative reviewing and approval by partners and outsourced vendors
- Controlled access to audit trail and electronic signatures
- Taking control on your quality processes; Deviations, CAPAs and Change Control
- Issue alerts, assess risks, report status and initiate change
Featured Speaker:
Cyril Walsh, QUMAS Solutions Consultant
Originally Aired: October 23, 2008
Managing the Successful Transition to eCTD
Webinar Overview
Since January 1, 2008, the FDA has required 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 deadline for eCTD has been 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
Featured Speaker:
Patricia Santos Serrao, RAC, Regulatory Advisor, QUMAS
Originally Aired: October 9, 2008
New Era in Governance, Risk and Compliance: Increase Efficiency in Managing Risks, Internal Controls, and Compliance Processes Across the Organization
Webinar Overview
Today, financial services institutions are at a critical crossroad for defining, managing and defending their enterprise risk management strategies. The sub-prime mortgage crisis, record write downs, global credit tightening, reevaluation of capital adequacy and regulatory inquiries are pressing issues that challenge and exhaust compliance, risk and litigation resources.
In this 45-minute presentation, we will discuss strategies that risk and compliance managers can use to streamline efforts to achieve greater transparency across the organization including:
- The benefits of a single, consolidated framework for defining, measuring and managing risks, internal controls and loss events.
- Key considerations for actively managing policy and procedure documents in support of internal controls, compliance requirements, and regulatory changes.
- Efficiencies that can be gained from actively monitoring events and managing business processes.
- The advantages of integrating risk and compliance management with global regulatory reporting to provide better insight and assurance of meeting regulators' expectations.
- The importance of interactive dashboards that provide at-a-glance views of risk assessments, compliance, and loss events along with tracking of corporate policies, deadlines, documents, and people.
- Real-world examples of where you can start and how you can measure progress.
Featured Speaker: Murtuza Vasowalla, QUMAS & Stephan Schmitz, FRSGlobal
Originally Aired : Wednesday, May 21, 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
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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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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