Compliance Training Webinars for Regulated Industries

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.

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.

This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products. Six years after the announcement of the FDA’s cGMP Initiative for the 21st Century, the FDA has finally coalesced on an approach it calls “Quality by Design.” Despite numerous presentations by FDA officials, several pilot programs and the adoption of Quality by Design by the International Conference on Harmonization (ICH), confusion about Quality by Design reigns throughout the pharmaceutical, biotechnology and medical device industries.

This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies. This presentation will provide an understanding of the tools of risk management and how to integrate risk management into an effective internal audit program.