Recorded Webinars

Internal and external audits are critical for ensuring an enterprise-wide state of control over your organizational processes. These webinars provide a comprehensive overview how to manage internal and external audits on a global scale.

Effective CAPA management is central to the vision of an Integrated Compliance Management strategy. Our collection of CAPA and Nonconformance Management webinars has been assembled to show how an effective CAPA process quickly identifies the sources of potential problems and facilitates fast action to resolve issues, and drive an organizations quality and continuous improvement programs.

Companies in every industry today are bound by guidelines for governance, risk and compliance. Each is subject to different areas of scrutiny in varying areas of operations. Regardless of industry, however, successful companies reach corporate accountability by proving to stakeholders that their business is reliable, compliant, and sustainable. These webinars show how achieving the level of operations and reporting requires a unified GRC strategy that guides people, standardizes processes, and integrates technology to embed governance, risk, and compliance (GRC) at every organizational level.

Regulatory trends from 1997-2002 showed that more than 40% warning letters were due to issues with validation, procedures, and documentation. Our webinars explain how an enterprise-wide approach to document management and SOP enforcement can benefit your organization.

The environment, "going green", and safety have become key concerns in this economy. By combining an automated quality management system with environmental health and safety (EHS) management system, companies can leverage a single platform and environmental strategy to spur innovation and increase profitability and sales. Our webinars explain different environmental approaches to help companies achieve these compliance goals and strategies.

Worldwide competition for marketshare continues to grow and every business is looking for an edge. These webinars address current business strategies for finding an edge and remaining one step ahead of the competition.

Of all the continuous improvement efforts Food & Beverage companies have undertaken, none are more vital than quality and safety. By having total automated quality and safety process control, Food & Beverage companies can look at achieving consistent yield and uniformity from product to product, and from batch to batch, with increased traceability and trust along your entire production process for complete sustainability. Our webinars explain different HACCP, safety and quality approaches to help companies achieve their compliance goals and strategies.

For regulated organizations, quality problems and non-compliance have very serious consequences. In addition to consumer safety concerns, failures in quality can result in product delays, fines, recalls and even plant shutdowns. This collection of webinars is designed to highlight the importance of an integrated compliance management to comply with the tightening compliance standards of regulatory agencies.

GMP regulations require a quality approach to manufacturing. Failure to comply with GMP regulations can result in very serious consequences including recalls, seizures, fines, or other penalties that can put a manufacturer out of business. Enterprises need to understand that GMP is a good business tool for refining both compliance and performance. Learn how GMP requirements will help your company better itself as it moves toward a quality approach using continuous improvement.

Established and emerging laboratories face key regulatory, quality, and safety challenges, including meeting timelines and driving down costs, while ensuring the quality, accuracy, and integrity of test results and other laboratory data. As a result, an increasing number of laboratory organizations are seeking solutions for sustaining compliance and ensuring ongoing viability and performance. These webinars address clinical, medical, environmental, research and testing laboratory management operations and their role in overall quality management.

While it seems the possibilities in Manufacturing are endless, even traditional industries are challenged to remain compliant, accelerate production, achieve world-class quality, and exceed customer satisfaction. Our Manufacturing webinars explain how manufacturers must meet quality and compliance requirements and guidelines, including ISO (ISO 9001, ISO 14001 and ISO/IEC 18000) and OSHA to improve a companies’ revenue growth and market expansion while transforming compliance into a competitive advantage.

Manufacturing organizations are beginning to recognize that electronic reporting to regulatory and other government bodies is part of operational evolution. Maximizing the benefits of the evolution means a change in business culture and processes is required, and the impending transition is important to clearly understand. Learn how you can help your organization prepare for the paradigm shift and begin implementing the newest electronic regulatory reporting systems.

Life Sciences companies frequently experience lengthy approval delays as they bring new products to market. Today, submissions to multiple regulatory bodies are often prepared and submitted through a manual, paper-based process whereby managing the lifecycle, tracking changes, assembling and submitting the right data can be a challenge. These webinars review different submission requirements from eCTD and labeling to Clinical Disclosure Transparency.

An increasing number of regulatory mandates and more active involvement among shareholders are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise. By implementing an integrated Risk Management system enterprise-wide, organizations can reduce the potential inefficiencies that result from unanticipated operational disruptions and evolving regulations and restrictions. These webinars demonstrate how effective Risk Management ultimately promotes healthy operating margins, process efficiencies, quality and compliance, and overall profitability.

Businesses rely on suppliers to maintain their efficiencies. Even a minor breakdown in the supply chain, or a slight deviation from quality performance, can cost an organization valuable time and reduce profitability. Learn how an automated supply chain quality management system can support enterprise-wide collaboration, planning, execution, and coordination of the supplier network, and help businesses adapt their supply chain processes to today’s growing competitive environment.

FDA-regulated organizations must comply with record-keeping requirements for a host of regulated information. While the use of automated record-keeping systems results in great advantages for the generation, tracking, maintenance, and analysis of such data, the use of these electronic systems opens up an array of new compliance issues and requirements. One of these key requirements is to perform validation of automated systems. The FDA has placed responsibility for software validation on the user to ensure that the application is suitable for its intended use and complies with 21 CFR Part 11. Learn how validation is used to provide objective evidence that the system is under control and working within defined specifications.

Software as a Service (SaaS)

Whether you’re an emerging growth company or simply looking for a cost-effective risk, compliance and quality system, a SaaS (hosted) solution can you to quickly and easily acquire an essential business application without a significant up-front capital investment. Hear how the SaaS option shifts the burden of implementing an enterprise application from you, as the customer, to the host, enabling you to begin using a solution quickly, a benefit that can rapidly translate into bottom-line results.