Webinars and Webcasts

Document Management Best Practices for Emerging Life Science Companies

Learn the industry’s best practices for initiating and implementing an electronic document management solution for start-up and emerging Life Science organizations. See how a powerful configurable automated tool can help you meet your document management needs and allow your organization to efficiently utilize the right resources at the right time.

Duration: 60 min.

Training Management Best Practices for Emerging Life Science Companies

Management of employee training is an essential and required quality process that all pharmaceutical, medical device, and biotech organizations must address in a highly regulated environment. See how using a powerful automated solution can meet these training management needs and allow your organization to efficiently utilize the right resources at the right time.
Duration: 60 min.

THE FDA'S EMDR MANDATE: ARE YOU COMPLIANT?

See how a compliant eMDR solution delivers improved on-time reporting and can substantially improve accuracy and productivity. Learn how you can electronically submit and manage your adverse event reports integrated with a complaints management process to better centrally manage and control your adverse event reporting.  See an in-depth demonstration of the product and watch actual submissions being processed and accepted by the FDA’s submission gateway.

Duration: 55 min.

NERC-CIP Compliance Workflows & Documentation Webcast

Learn how automated NERC compliance management can help with CIP-002 thru CIP-009 compliance and documentation. This webcast examines best practices for managing CIP workflows including configuration, change management, and process/plan review workflows; and details the best methods to track and store compliance documentation such as compliance basis rationale, evidence, tasks and review results.

Duration: 60 min.

Completing your EQMS with Automated Audit Management

This webinar provides an overview of the elements that make up a best practice automated audit management system. You’ll also see an implementation-ready (and fully configurable) audit management system.

Duration 55 min.

Patch Management for NERC CIP Compliance: Turning Awareness into Action

This webinar provides an overview of how the AssurX Patch Management solution solves the security challenge of managing cyber asset patching across IT, OT, and IoT infrastructures for effective risk mitigation and NERC CIP-007 compliance with BES Cyber System Security.

Duration 40 min.

Asset Configuration Change Management Best Practices for NERC CIP-010

This 30-minute webinar from AssurX provides a real-world look at challenges that present when operationalizing and automating a CIP-010 compliance system, as well as proven approaches for overcoming those challenges.

Duration 30 min.

6 Elements of a Modern Change Management System

This webinar discusses and demonstrates how an electronic change management system dynamically manages change evaluation, planning, implementation and documentation.

Duration: 50 min.

AUTOMATING YOUR QMS: PITFALLS & ESSENTIAL STRATEGIES

Learn the common pitfalls to avoid and essential steps to take when planning and implementing software automation within your quality management system.

Duration: 25 min.

Automated Corrective Action Best Practices with Denise Robitaille

Developing and managing a corrective action process that improves your company offerings and complies with industry regulations is daunting enough without the requirement to automate it using software. Without control and support, corrective action can deteriorate into a time-consuming waste of resources that is a detriment to your organization. This webinar will cover the best practices for automating a corrective action process and how automated software can facilitate management of this process for improved effectiveness and efficiency.

Duration: 60 min.

Failproof Readiness: Preparing for a NERC Compliance Audit

This webinar covers strategies for responding to NERC compliance audits including NERC Pre-Audit Questionnaires and Reliability Standard Audit Worksheets (RSAWs). Hear clear strategies and learn what’s really required and what you are up against. AssurX will also demonstrate its CATSWeb ER (Electric Reliability) NERC compliance management software that acts as a tracking tool and repository for managing and storing the requisite information and documentation.

Duration: 55 min.

Integrated NERC Compliance (Including CIP) Programs

Coping with changing standards and evidence collection for NERC and Cyber Compliance with a small workforce using spreadsheets and limited compliance applications is challenging, if not impossible, for Registered Entities. Learn how automated, integrated compliance solutions have proven to not just get the job done, but also build proactive compliance programs for utilities, generators, and cooperatives of any size.

Duration 55 min.

Automating Policy and Procedure Management for QMS

Growing Your Compliance Program: A Maturity Model for NERC Compliance

Who Moved My MDR? Assessing Organizational Readiness for EU MDR

In this webinar, experts will discuss how medical device manufacturers and companies that distribute devices and/or drug delivery systems to European Union membered countries will experience an organizational shift once EU MDR is fully implemented in May 2020.

Duration 45 min.

Simplifying NERC Compliance by Automating Reliability Standard Audit Worksheets (RSAWs)

This webcast demonstrates how utilizing a dynamic RSAW management system enables Registered Entities to be spot check and audit ready with current NERC requirements.

Duration: 47 min.

NERC Compliance Best Practices: Evidence Collection, Action Tracking, Schedules and Document Management

This webcast discusses how Registered Entities are handling changing standards and evidence collection for NERC Compliance with limited resources using automated compliance management systems. Learn about the AssurX system can help utilities, generators, and cooperatives of any size achieve and maintain NERC compliance initiatives.

Duration: 55 min.

Ensuring NERC Compliance: PRC-005 Protection System Maintenance

Learn how registered entities are tracking their maintenance programs with the changes to the PRC-005 NERC standard. See how a comprehensive time-based program that addresses component maintenance activities, classifications, and standard directed minimum time-based interval requirements can help utilities, generators, and cooperatives–large to small–achieve and maintain their NERC compliance initiatives.

Duration: 55 min.

A Complaint Management Primer: Compliance-Driven Strategies for Effective Complaint Management

The webinar provides a high level overview of proven strategies for implementing a complaint management process that facilitates gathering, evaluating, investigating and remediating complaints from the premarket stage to closure as well as what practices to avoid.

Duration: 30 min.

Complaint Management for Life Sciences: A Best Practice Approach

Learn best practices for initiating and implementing an electronic complaint handling solution for pharmaceutical, medical device, or biotech organizations. See firsthand how a configurable software platform automates and streamlines the entire complaint management process—from complaint intake, through review, investigation, regulatory reporting, and returned product shipment tracking. Ensure complaints are handled quickly and efficiently, utilizing the right resources at the right time.

Duration: 48 min.

5 Pillars of a Modern Quality Management System

This webinar discusses how the modern QMS has evolved to facilitate all compliance with GxPs, FDA, HACCP, ISO standards and more.  The presenter explores five (5) essential pillars that form the foundation of today’s modern quality management systems. See how leading companies use automation to streamline end-to-end issue management across the enterprise, as well as build cultures that make safer products and drives business change and growth.

Duration 45 min.

EU MDR Implementation and Organizational Change Management

This 20-minute webinar from AssurX provides a high-level perspective on key MDR changes and interdependencies across the product lifecycle.

Duration 20 min.