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BIOVIA Quality Webinars

Today’s science-based companies are very aware of the importance of Quality in conducting a successful business and sustaining competitive advantage. Therefore, many enterprises have a Quality Strategy in place.

Although a Total Quality Strategy is required and executable, the actual implementation might be challenging. Quality has to ensure both Regulatory Compliance and Operational Excellence through high quality processes, documents, materials and products underpinned by meaningful metrics. At the same time processes need to be streamlined and cost efficient to reduce compliance costs and cost of poor quality.

The BIOVIA Total Quality solution supporting an advanced Total Quality strategy includes capabilities for Quality Process Management, Quality Control and Testing, Materials Quality Management, Quality Document Management and Quality and Process Data Analytics.

Webinars will continue to be added to this series, please check back often.

Past Webinars in the Series

Title and Speaker

The Impact of the new Clinical Data Management, IDMP & Electronic Submission Mandates
Speaker: Warren Perry and Kyle Boelter, Dassault Systèmes

Gain insights into recent and upcoming mandates for e-Submissions, Clinical Data Interchange Standards Consortium (CDISC), and IDMP and understand how these changes may impact the way your organization manages the lifecycle of its documents and data.

Download this webinar to learn about:

  • IDMP standards
  • Submission e-Mandate and timing
  • CDISC standards and timing
  • Building a connected system that maintains data from the lab to the patient
 Watch Now

Data Integrity – A GAMP® Approach
Speaker: Sion Wyn, Director, Conformity Ltd.

Data Integrity is currently a key focus area for regulatory agencies worldwide. The use of information technology and computerized systems in all aspects of life sciences continues to grow, and is leading to the automation of more and more product life cycle processes.

Download this webinar and discover:

  • What are the key regulatory concerns and key focus areas related to data integrity?
  • The main objectives, concepts, and definitions of data integrity
  • What steps regulated companies and their suppliers need to take to ensure data integrity
  • The new ISPE GAMP guidance on this topic
 Watch Now

Digital Continuity: The Holy Grail
Speaker: Kevin O’Leary, Head of Quality, Regulatory and Compliance Solutions, Dassault Systèmes Guillaume Kerboul, Business Consultant Director Life Sciences Industry, Dassault Systèmes

Discover what ‘Digital Continuity’ is, how other industries have approached it and how Life Science organizations can benefit from this next frontier in pharma innovation.

This webinar to learn how a digital continuity strategy will enable you to;

  • Choose the correct path towards global data harmonization and standardization, adopting standards such as IDMP, ICH
  • Achieve greater transparency across the entire drug lifecycle
  • Drive compliance, but also improve business process and data management efficiency, resulting in a significant competitive advantage
  • Leverage a ‘Single Source of Truth’ to increase collaboration and visibility across the entire ecosystem

Register today to find out how you can design quality and regulatory compliance into every stage of your product life cycles

 Watch Now

How to Enable Data Quality Across the Product Lifecycle in the CPG Industry
Speaker: Nick Reynolds, Principle Applications Scientist, Dassault Systèmes BIOVIA

Your data related to product quality, safety and regulatory compliance are intrinsically linked.

Yet so often this essential data is spread out in disparate, error prone, paper based systems.

This webinar introduces a solution: an integrated system which connects all stages of the product lifecycle. From ideation and creation to product development and manufacturing.

This webinar outlines how, through "Digital Continuity", data can be maintained from the ideation/discovery phase through development, safety and environmental testing and regulatory approval to manufacturing.

This is for you if you want to:

  • Make better decisions and make them faster
  • Improve overall data quality and integrity
  • Save time usually wasted identifying data and ensuring accuracy
  • • Encourage standard work practices across your organisation

Register today to find out how you can design quality and regulatory compliance into every stage of your product life cycles

 Watch Now

Spending too much time on Annual Product Quality Reviews?
Cyril Walsh and Stephane Vellay
BIOVIA

  • Do you struggle with the collation of data from multiple disparate systems when generating your Quality Reports?
  • Are you spending too much time waiting for data, on CAPAs, deviations, process monitoring charts, batch record details, from the other stakeholders before you can create the appropriate reports?
  • Are you confident in the data integrity and accuracy of information you are receiving from colleagues?
Download this complimentary webinar and learn how to significantly reduce the time required to generate large documents such as Experiment Summaries, Certificates of Analysis and Annual Product Quality Reviews (APQR)

 Watch Now

One Quality for Enterprise Excellence
Ken Hayward
BIOVIA

Moving to a unified quality strategy will ensure enterprise wide data integrity and consistent reporting

Many companies look at their quality and compliance programs as obligations or burdens. However, connecting quality and compliance processes is all about business performance, and having the ability to execute and accelerate the business, while reducing risk, improving quality and meeting all regulatory demands.

Connecting quality and compliance processes and the ensuing productivity gain is an opportunity that all regulated companies should recognize.

Download this webinar to learn about:
  • Enabling business interoperability through technology: collaboration & control in a global world
  • Integrating the manufacturing process and quality excellence
  • How digital continuity makes quality data and documentation available throughout the product lifecycle
  • The benefits of a total quality approach for achieving business performance excellence

 Watch Now

EQMS and Quality Metrics – An Indispensable Part of a Total Quality Strategy
Dr. Daniela Jansen
BIOVIA and Cyril Walsh, BIOVIA

  • Is your Quality Organization faced with some of the following challenges?
  • Disparate quality systems and data sources
  • Inability to access Quality Data and Documents in a timely manner
  • Managing Data flows between suppliers, CRO’s, CMO’s and partners in a compliant way
  • Conducting the Product Quality Review or Annual Quality Review efficiently

As the FDA requests the implementation of Quality by Design, life science organizations are realising the positive business impacts of moving from mere compliance to a broader ‘Total Quality’ approach.

A Total Quality Strategy aligns corporate and operations objectives by clearly defining roles, responsibilities, processes, activities, points of collaboration, technologies, and metrics across the entire value chain and in each functional area therein.

Register for this webinar to learn how to address common Quality challenges, by leveraging core Total Quality components, EQMS and Quality Metrics, to drive increased efficiency, reduce costs and improve quality and compliance.

  • How to minimize non-value-added manual tasks and increase efficiency in Quality Data and Document Management
  • How to reduce the cost of periodic reporting for review and compliance (Annual Product Review – APR, and Periodic Review – PQR)
  • How to support collaboration and communication within your internal and external ecosystem
  • How an integrated, end-to-end Quality solution can help drive Compliance, Process and Quality Excellence across the entire product lifecycle

 Watch Now

QMS Demonstration: The Core of your Total Quality Strategy
Cyril Walsh,
Sr. Solutions Consultant, BIOVIA
Daniela Jansen, Ph.D.,
Sr. Solution Marketing Manager, BIOVIA

The basis for a Total Quality Strategy is a comprehensive as well as a flexible Quality Management System.

Join this demonstration to see how an electronic QMS can assist your organization in:

  • Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
  • Collaborate and operate efficiently on SOP content
  • Manage users training requirements/expectation
  • Ensuring compliance to 21 CFR Part 11 and immutable audit trail.
  • Taking the resource burden out of creating dashboards/ periodic reports

Total Quality will then not only ensure compliance but lead to improved product and process quality with increased consistency and reliability, reduced costs, improved productivity, and improved cross functional collaboration.

 Watch Now

The Importance of Implementing a Total Quality Strategy in Life Sciences
Matthew Littlefield,
President and Principal Analyst, LNS Research
Daniela Jansen, Ph.D.,
Sr. Solution Marketing Manager, BIOVIA

In a recent survey conducted by LNS Research of over 1000 companies, the top quality management challenges facing Life Sciences companies are quality departments being viewed as a policing function and disparate quality systems and data. There are many reasons life sciences companies face these challenges, from poor organizational structure that allow silos to persist to the lack of a comprehensive Total Quality approach.

In this upcoming webcast, President and Principal Analyst LNS Research, will present a new framework for understanding how to implement a Total Quality Strategy in life sciences. This framework is built upon the well-established ISA-95 model to include a complete value chain perspective and drill down to examine the interactions between quality functions and business processes across research, development, compliance, manufacturing, and delivery. In the webcast benchmark survey data will also be presented and many questions will be answered including:

  • How can my company start on a Total Quality journey?
  • What is the difference between a plant level non-conformance and enterprise CAPA?
  • What are the critical integration points for EQMS, Quality Control and Testing, and Materials Quality Management and more?
  • What is the relationship between enterprise quality processes, materials and document management?
  • What quality metrics drive business performance?
  • What are the business benefits of a Total Quality Strategy?
  • How many companies today have implemented quality management best practices and how many are planning to?

 Watch Now

Bringing your Total Quality Strategy to the Next Level
Daniela Jansen, Ph.D.,
Sr. Solution Marketing Manager, BIOVIA
Cyril Walsh,
BIOVIA Sr. Solutions Consultant

The basis for a Total Quality Strategy is a comprehensive as well as flexible Quality Management System. In order to achieve complete Quality coverage organizations need to go beyond a traditional Quality approach including all quality relevant processes, materials, documents, and metrics for every phase of the product lifecycle from ideation to post-market. Quality must become a behavioural change that is enabled by adequate tools and systems. Total Quality will not only ensure compliance but lead to improved product quality with increased consistency and reliability, reduced costs, improved productivity, and improved cross-functional collaboration.

During this webinar BIOVIA will highlight:

  • Key items to consider when implementing a Total Quality Strategy
  • Quality related challenges that can be addressed by a Total Quality approach
  • The business benefits of a Total Quality Strategy that goes beyond Compliance
  • How BIOVIA Total Quality can improve Quality throughout the entire product lifecycle
  • How to leverage an integrated EQMS as the core of your Total Quality approach

 Watch Now

Building Compliance and Operational Excellence into your Quality Lab Operations
Presenters:
Gene Tetreault, Sr. Director, Products and Marketing for the Laboratory Informatics Portfolio
Dr. Daniela Jansen, Product Marketing Manager

Typical paper-based Quality Testing systems are not only inefficient and extend process times; they are also the one overarching cause of high compliance risk. The inherently error-prone, paper-based Quality Testing systems deployed at many Pharmaceutical and Biological manufacturing sites can become serious issues during FDA Quality Testing inspections. FDA-issued 483 warning letters are only the beginning of a significant remediation and "corrective and preventive action" (CAPA) process that takes additional time and money away from what the Quality Testing system should be focused on the release of product.

This webinar will discuss these challenges and illustrate a typical workflow with the BIOVIA Quality Testing solution that helps to overcome these challenges.

 Watch Now

 

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