Maximizing Your TrackWise EQMS InvestmentDate: Wednesday, May 20, 2015Time: 4:00pm GMT / 11:00am EDT / 8:00am PDT
GxP Compliance Strategies for Continuous Process ImprovementDate: Tuesday, June 2, 2015Time: 11am ET / 8am PT
FDA Initiatives and Regulatory Trends for Life ScienceDuring this webcast, Larry Spears, former Deputy Director for RA at the FDA CDRH, and Dirk Dusharme from Quality Digest, discuss FDA initiatives and trends over the next several years and what impact that will have on Life Science establishments.
Overcoming Complaint Handling Challenges with TechnologyDuring this webcast, Sparta
System experts explore how integrating the complaint handling processes,
including eMDR, into an overall enterprise quality management solution
facilitates a seamless environment for complaints to initiate
investigations, CAPAs and other quality activities – streamlining
processes and reducing complaint investigation times and assessment
A Multi-Billion Dollar Brand Perspective: Managing Product Quality throughout the Global Supply ChainGlobal product quality is impacted by financial pressures, regulatory requirements and a complex, global supply chain. This webcast examines some of the biggest challenges in ensuring global quality across a complex supply chain and what best practices have been incorporated at PepsiCo to achieve business value.
Utilizing Enterprise Quality Management to Optimize the Supply Chain and Gain Greater Visibility Into Processes Across the Business EcosystemThis webcast discusses how organizations can more effectively enable CMOs and Suppliers to more easily collect and share quality related information; how to more efficiently provide Supplier and CMO quality information across departments within a manufacturer; and, how to build a culture of quality and collaboration both internally and externally through the use of information.
The Impact ISO9001 Revisions Will Have On Your Business and QMSDuring this webcast, Sartorius and Quality Digest discuss the values of
ISO 9001's core competencies and how the new ISO 9001:2015 changes will
affect manufacturers quality processes.
Product Registration Tracking for the Chemical and Agrochemicals IndustryDiscover how to streamline and automate your submissions process, fulfill regulatory requirements more efficiently and access key information to enhance decision making and improve manufacturing/supply chain planning.
CAPA – The Driving Force Behind Quality Management WebcastA corrective and preventive action (CAPA) solution is one tool to achieve these objectives. This webcast explains the essential elements for implementing an effective CAPA system to help increase patient safety in the pharmaceutical industry.
Recognize How Global Change Control Impact Your Product QualityDuring this webcast you will learn how medical device companies can satisfy key business drivers such as global supply chain and M&A needs by implementing an efficient enterprise change control system.
The Technology of QualityThis webcast, co-hosted with Quality Digest, explores technology trends and the quality management tools available to ensure and enhance the quality and safety of products & services. Using these tools have enabled leading organizations to achieve 20-35% quality process productivity improvement. These tools further increase value across the enterprise by providing visibility and traceability, lowering the amount of recalls and ultimately increasing patient safety.
Unlocking Quality & Value Across the Supply Chain with EQMSWith design, manufacturing and assembly of products often spanning multiple locations and even countries, learn how manufacturers are striking a balance between the manufacturing process and quality control, improving quality and value across the supply chain with enterprise quality management.
Dominate Complex Registration Tracking Through AutomationLearn how an automated registration tracking system provides seamless integration with other processes such as change control, commitment tracking, pharmacovigilance reporting and Annual Product Reviews for true enterprise wide regulatory management.
Introduction to TrackWise 8.7 The release of TrackWise 8.7 continues our strategic investment into industry leading products and technologies that deliver immediate business value for our customers. TrackWise 8.7 is the most comprehensive TrackWise offering ever, providing access to new tools and services such as TrackWise Mobile, Analytics and Stratas.
Stratas 1.1 Stratas is a new cloud solution that extends TrackWise beyond your four walls to seamlessly connect external third parties to your company’s internal processes, thereby reducing risk and improving efficiency throughout the supply chain. The release of Stratas 1.1 features the ability to conduct service provider and supplier audits that provides a critical view of systems and compliance with operational and business procedures Observations and findings from these audits can be used to build a foundation for risk management and help align audit resources and manage compliance risks.
Recipe for Success: Food Safety Regulations and the Role of Quality ManagementAs food markets become more global, governments in the United States and around the world are increasing their focus on food safety by implementing sweeping new regulations while reinforcing adherence to existing regulations. Meeting these food safety standards requires better traceability, improved supply chain visibility, and more efficient quality process standardization from food and beverage manufacturers. Learn how leading food and beverage manufacturers are able to monitor and coordinate quality-related processes across the supply chain, achieving measurable benefits in product safety, operational efficiencies and brand value.
Increase Control over Quality Management Through Strong Supplier RelationshipsLearn
how pharma/biotech companies can connect external suppliers and
contractors to their company’s internal processes through a cloud-based
supplier quality management
solution and the financial impact that has on the bottom line.
The Best Recall is the One You Never Have to Do - WebcastToday’s Consumer Products companies are relying more and more on global suppliers to reduce costs and stay competitive. But this adds to the complexity of developing finished goods, limiting the visibility of procedures and processes used, thus increasing the risk of a product recall. In this webinar, learn where issues happen, how they can impact the company, and how an enterprise quality management solution can help companies reduced that risk.
EQMS & Complaint Management DemoComplaints are one of the origination points of quality events, and probably the most critical. And the complaint investigation process can take many directions. Learn how a global complaint management system allows for collaboration to quickly determine the cause and take the necessary actions.
Managing Quality Across the EnterpriseManufacturing companies today are challenged by mounting pressures such as market demand, cost reduction and product recalls to ensure quality and compliance across a complex supply chain. In this webcast, listen to industry experts discuss the quality issues faced today, and learn about the best practices leading manufacturers are leveraging to manage quality across the enterprise, standardizing processes to improve efficiencies, reduce costs and ensure better business outcomes.
Using Analytics to Improve Quality in the Supply ChainProtecting a company’s brand, reducing risk and ensuring product safety are critical factors for today’s manufacturing companies. To support these dynamics, companies need to ensure the quality of products, and have insight into the quality processes across the supply chain. Moderated by Quality Digest, listen as industry experts discuss the value of real-time analytics within quality management software systems, providing critical visibility into every aspect of your quality processes.
Boost Supplier Performance Levels Using an Automated Audit ProcessMedical Device companies are held responsible for defective products when in the marketplace, regardless if it was a 3rd party supplier responsible for the damaged part. Learn how an automated audit solution allows companies to create a closed-loop system that integrates with other quality related systems and processes when managing supplier quality.
Extending TrackWise Beyond the Four Walls with StratasHear how Stratas addresses critical marketplace needs by integrating and extending quality related processes across the organization's entire supplier and partner network.
The Evolution of Automated Audit ManagementLearn
how companies are planning and executing audits more efficiently by
automating the steps in the audit lifecycle, including; scheduling,
preparing, responding and corrective action (CAPA). In addition,
discover ways to mitigate risk, bolster productivity, improve product
quality, and increase visibility for better decision making.
Understanding UDI Lifecycle Steps to Improve Patient SafetyA UDI system will provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls and provide a foundation for a global, secure distribution chain. This webcast explains the UDI lifecycle steps and the benefits of an automated UDI system to enable more accurate reporting, review and analysis of adverse event reports so that problem devices can be identified and corrected more quickly to improve patient safety.
Leveraging Audits to Strengthen Supplier RelationshipsManufacturing companies rely on supply chain integrity when dealing with a multitude of suppliers to produce their products. Learn effective techniques of supplier audits that enable companies to raise performance levels and strengthen supplier relationships.
Increased Productivity and Efficiency with TrackWise MobileListen as we discuss the benefits of having a mobile quality system in your company and watch as we walk through a day-in-the-life of a quality issue using TrackWise Mobile.
Technology Trends Influencing Enterprise Quality Management SystemsJoin Dirk Dusharme of Quality Digest and Judy Fainor, Sparta Systems' Chief Architect, as they examine some of the most prevalent trends effecting highly-regulated industries.
Understanding the Value of QualityLearn about Aberdeen's recent manufacturing research regarding the increasing importance of using quality to address operational inefficiencies at the global level as well as increasing product and service competencies.
Build Your Strategic Sourcing Strategy Focusing on QualityIn this webcast, LNS President and Principal Analyst Matthew Littlefield will share results of a recent EQMS study involving over 500 manufacturers. This new research highlights the right quality metrics to measure and provides a roadmap for making dramatic improvements in performance.
Drive Business Success Using an Effective Complaint Management SolutionListen to Dirk Dusharme, editor-in-chief of Quality Digest and industry expert, Dick DeRisio, as they explain some challenges they've experienced with complaint handling and the strategies learned to manage through the process with successful results.
Tools for Effective Supplier Controls in Support of the Medical Device IndustryLearn about industry trends in warning letters citing compliance issues associated with supplier controls and how you can augment supplier management tools with automated software.
Ensuring Global Regulatory Compliance for Product Registrations: Strategies for Risk Reduction and Operational EfficiencyLearn from industry and regulatory experts on how to create a robust quality management system for complying with country-based and regional-based regulatory requirements for new product registration, product changes, and labeling changes. Gain insight into how to use automation for effectively tracking product registration and related correspondence to ensure global regulatory compliance.
Importance of Supplier Quality Management in Electronics/High Tech CompaniesListen to LNS Research share results of a recent EQMS study involving over 500 manufacturers. This new research highlights the right quality metrics to measure and provides a roadmap for making dramatic improvements in performance.Effective Strategies for Compliant HandlingLearn as the presenters explain some challenges they've experienced with complaint handling and the strategies learned to manage through the process with successful results. (1:05:57)
Protect Your Brand: Ensuring Food Safety and Compliance with a Quality Management SystemLearn how your company can manage risk and protect brand reputation in the ever changing food and beverage environment. (1:10:35)Global Change Control: Managing Change as a Best Practice, Not Just ComplianceLearn how implementing and managing a successful, automated change control solution improves cycle time and time to market, supports global supply chain initiatives, enhances product quality and flexibility to adapt to changing regulations and in turn, reduces operational cost. (59:10)
Turning Quality Data into Quality Insight with TrackWise AnalyticsLearn about the exciting new TrackWise Analytics solution and how it can be used to gain improved system ROI, greater visibility into existing quality issues, and ultimately enable organizations to be more proactive in managing quality across the enterprise. (51:53)
Tracking your Product Registration Process is That EasyEffortlessly meet regulatory requirements, strategically drive competitive product portfolios, and maintain a competitive market edge with an enterprise quality software solution. (41:47)
Flawless Execution of your Audit Process Through Automation Learn how a quality management solution helps auditors to plan and execute internal and external audits more efficiently in the manufacturing industry. (57:04)
GLP and GCP Auditing: Why Preclinical and Clinical Auditing Belongs in a Comprehensive EQMS Explore preclinical GLP and clinical GCP auditing solutions and learn how to automate workflow processes by managing all steps in the preclinical and clinical audit lifecycle. (52:52)
Do More for Less with an EQMSLearn how you can manage costs and improve operational efficiencies by centralizing and harmonizing manual systems for business critical processes through use of an enterprise quality management system. (58:49)
Simplifying the Audit Management ProcessLearn how TrackWise can simplify and improve productivity, reduce costs and streamline your audit processes in the most effective manner. (48:34)
EQMS: Accelerating Quality OutcomesThis webcast will allow quality professionals to better estimate and communicate the value of their quality management systems accelerating quality management outcomes that can be measured by their financial and operational peers. (1:01:02)
Managing Product Quality and Business Process Efficiency Throughout the Global Supply ChainDiscover how to manage risk and ensure full supply chain visibility and oversight, including supplier relationship risk assessment and risk-based auditing. (31:17)
A Complete Quality Management System Extends Across the EnterpriseExplore how a true enterprise quality management system has the inherent ability to harmonize all quality processes from each functional area, across all regions, and throughout the critical supplier network, providing the necessary visibility and transparency to quality issues and global trends. (50:16)
Closed Loop Quality for Consumer Products ManufacturersThis webcast outlines key quality metrics and how closed-loop quality management software can help consumer products companies achieve operational excellence. (59:05)
Enterprise Quality Management for Manufacturing: Increasing Brand Reputation through High Quality ProductsThis webcast discusses how companies can manage suppliers in various regions based on their commercial risk, performance capabilities, strategic development and corporate vision requires central harmonized and standardized processes with visibility to management. (45:47)
How an EQMS can protect your customers, keep you compliant, and have a positive effect on your bottom lineThis webcast explores how to bring related processes together on a global basis, and integrate systems to create transparency and effective and timely decision making. (1:04:44)
Product Registration Tracking - Avoid Costly Errors & Improve EfficiencyIn this webcast, you will hear a Becton Dickinson case study that illustrates how global registration tracking can be made more efficient and less risky. (41:47)
Improving Total Cost of Ownership with Enterprise Quality Management SolutionsLearn how utilizing a single platform to manage quality and regulatory issues enables a broader and deeper view across the organization. (58:53)
Managing the Complex Supply Chain EcosystemLearn about industry trends and best practices on managing the complexities of the supply chain. (58:17)
Cost-Effective On-Demand TrackWise TrainingExplore how Sparta Systems on-demand TrackWise training solution can assist your company with training audiences on the basic concepts of TrackWise. (43:26)
Best Practices for Implementing a Global Change Management SolutionHow implementing a global change control cycle system as part of an organization's enterprise quality management system improves quality, streamlines the product release process, and reduces risk. (54:12)
Medical Device Regulatory ReportingIn this presentation learn from Howard Press, formerly of the FDA what's changing in e-Reporting, options for compliance and guidance on justifying automation. (59:56)
Supplier Quality Management Strategies for Enterprise Quality Management Systems This webcast is designed to cover SQM from every angle, from identifying new suppliers and the corresponding evaluation process to ongoing supplier oversight to ultimately decommissioning the vendor. (54:20)
Environmental, Health and Safety, Incidents and Risk Management: Improving Efficiency, Accountability and Safeguards This presentation explores how organizations can maintain compliance and efficiently manage and track key processes and actions based on organizational SOPs, local government rules, and both federal and international compliance guidelines in conjunction with global regulations and standards for Environmental Health and Safety Management. (54:36)
Enterprise Integration: Harnessing the Full Value of an Enterprise Quality Management SystemThis presentation reviews the business drivers for integration of quality management software with enterprise applications such as enterprise resource planning (ERP), customer relationship management (CRM) and laboratory information management (LIM) systems. Examples of enterprise QMS integration are also presented. (59:33)
Food Safety Legislation and Regulation - Ready or Not?Industry experts from Axendia and Sparta Systems provide an update on the status of legislative proposals on food safety, discuss how to prepare for the next generation FDA audit and identify key risk areas based on anticipated penalties for non-compliance. (1:11:00)
Training Management Best PracticesThis session provides an overview of the common pain points for companies using manual and segregated training management methods. Review this webcast to learn how a fully integrated, web-based training management improves training as an integral part of an organization's corporate-wide quality and compliance programs. (46:27)
Introduction to TrackWise 8This introduction to the latest release of Sparta Systems' industry-leading TrackWise software, provides an overview of product enhancements such as our next generation configuration management functionality and our new workflow visualization feature. (59:14)
Integration with Enterprise Applications: A Technical LookThis webcast takes a look at enterprise architecture and canonical models, solution architecture, TrackWise integration architecture and multiple real-world case studies, including integration with global complaint systems, clinical trial data and mobile devices. (59:33)
Complaint Handling and Regulatory Reporting for the Pharmaceutical Industry This webcast discusses best practices for the recording, investigation, resolution and reporting of complaints in accordance with good manufacturing practices (GMPs) and regulatory compliance mandates. (52:18)
Global Quality Management as a Business Imperative co-presented by Forrester and GenzymeForrester presents best practices and what to look for in a Quality Management Solution. Jon Voss, Vice President, Corporate Quality Operations Systems at Genzyme presents a case study. (1:03:51)
Quality Across the Supply Chain co-presented by Simon Jacobson, AMRThis joint Sparta Systems-AMR Research webcast will show how to embed quality throughout the supply chain. The webcast explores how the ownership of quality can be extended into the supply chain providing visibility, traceability and end-to-end quality excellence. (54:34)
Client Case Study: TrackWise, from Procurement to Implementation, at the European Medicines Agency (EMA)Learn how the European Medicines Agency managed a successful QMS implementation. The presentation also reviews the benefits of an electronic, configurable QMS, and the lessons learned that will prepare the organization for future process automation. (42:51)
- Noven Pharmaceuticals
- Gulf Coast Regional Blood Center
- Global Pharmaceutical Manufacturer