Compliance Training Webinars for Regulated Industries

This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generic and drug areas and the opportunities in the biologics areas. The fruits of the program can bring a higher success rate in the commercial operations with its impact on cost of goods, reduced reporting requirements or at least a reduction in the level of reporting for supplements and less complex or stressful inspections.

This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

Direct your organizations decision on whether to follow the ISO certification path or a Lean The purpose of this webinar will be to present how Lean - Six Sigma and quality management system problem

Using a reliable process to meet current quality standards to determine the verifiable causes of problems. Root cause analysis is a systematic method to determine the causes of non-conformances. To meet current quality standards, medical device companies must use a reliable process to determine the verifiable causes of problems.

This seminar will provide you with the tools you need to establish and maintain strong internal controls that meet Sarbanes-Oxley standards by reducing risk and protecting company assets. This presentation will provide you with the tools you need to establish and maintain strong internal controls in the A/R & A/P department that meet Sarbanes-Oxley standards.

This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis. This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

Understand why the VMP is a project management tool and why it’s a living, breathing document. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.

The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.

This presentation will cover the GLP requirements for animal studies, and the methods that laboratories employ to comply with the regulations. This webinar will be directed at personnel who must conduct or review the performance of non-clinical laboratory studies related to safety. GLP studies apply to animal studies that are required in all regulated areas.

In this presentation each on the categories and requirements of the PCI/DSS standard 1.1 will be compared to settings within the Virtualization configuration of a VMware ESX Server 3.x machine. Security professionals who wish to have a closer look at the security settings possible on a virtualization host for consideration when crafting detailed policies.

Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts. Bioassays are defined as any biological assay that can be used to show that a product will perform its’ stated function. Due to the nature of bioassays they are inherently variable and require extra care to achieve consistent performance.

Companies are unsure on what exactly to qualify or re-qualify test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. The USP has developed a new standard for analytical instrument qualification (AIQ). It will be official by August 1, 2008.

This Corrective and Preventive Action (CAPA) webinar will teach how the risk based approaches be implemented under CAPA.

This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents

Attend this seminar to learn about proven industry practices for network qualification. Configuration management and change control as the most important network qualification steps.

Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report. The US FDA is increasingly stating that many regulated activities should be "risk-based". Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach.

This webinar will focus on various legal issues to consider when your firm outsources its services or operations.

The keystone of AML compliance is the reporting to proper authorities of those transactions and activities considered to be suspicious