Compliance Training Webinars for Regulated Industries

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

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.

This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.

This webinar will discuss how to perform pre-study GLP compliance audits and what to look for at candidate nonclinical CRO This webinar will be valuable for any member of a pharmaceutical or biotechnology organization charged with placing or monitoring nonclinical GLP safety studies.

Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI). Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.

This webinar will discuss the FCPA and potential pitfalls that US businesses must be aware of when conducting overseas business.

A proven process for investigators will be presented to address common deficiencies with respect to costs associated with clinical investigator site requirements for studay conduct.

This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations. This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.

Legal penalties of noncompliance can be severe, but having a culture that allows harassment to exist can lead to lower productivity and costly turnover. Progressive companies today have a zero tolerance for harassment in the workplace policy.

Supervisors and managers will learn and demonstrate effective communication skills for meaningful conflict intervention and resolution. Each participant will design a strategy for conflict resolution using a real life workplace conflict situation.

This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss the importance, requirements, and elements of a root cause-based CAPA program, as well as detailing the most effective ways to determine root cause and describing the uses of CAPA data.

Attendees of this Webinar will learn how to transfer analytical methods in FDA and equivalent international environments. When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

This webinar will provide valuable assistance to all regulated companies that use cell or tissue based laboratory practices, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This webinar will describe and show applications of GCCP which can be used in vitro assays to increase quality standards in the laboratory environment.