Compliance Training Webinars for Regulated Industries

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.

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.

This will teach part 1 of defining and refining objectives and selecting the best of alternative courses of action.

The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented. This webinar will be valuable for anyone developing cell, tissue or gene therapy products, including those in the biopharmaceutical industry.

This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented.

This presentation will start with a review of the requirements for C-TPAT by member type and explain in detail what the validators are looking for at your company. Every member of the Customs and Border Protection’s C-TPAT program will go through validations.

In this webinar, we will review basic FDA expectations for evidence of adequate analysis and testing to identify the severity and likelihood of use errors, and validation of risk mitigations through usability testing with representative users. As applied to the overall Design Controls process phases, will be presented.

This webinar will provide valuable assistance to all regulated companies that need to validate their systems The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma

This webinar will provide valuable assistance to all companies that are required to maintain an OSHA 300 Log. This seminar will teach you how to analyze cases to produce accurate OSHA 300 Logs.

This OSHA compliance training will cover all the requirements of OSHA training that a medical practice or facility is required to provide.

AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.