Compliance Training Webinars for Regulated Industries

This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report, looking at important terms including Hazard, Harm, and Risk and explaining how to use each one. The program describes development of a Risk Evaluation form that implements the requirements of ISO 14971.

This webinar on archiving GLP records will discuss the options for managing large archiving facilities to small facilities with one-room archives. You will receive practical tips on how to correct mistakes that agencies have cited regarding archiving.

This 6 hour virtual seminar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.

This Webinar will help you understand the current FDA requirements regarding financial disclosure in clinical trials. It will discuss differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.

This 90-minute training on managing discrimination litigation risks will provide a comprehensive primer on reviewing compensation systems for internal equity and discuss why, in light of recent legal and regulatory changes, employers should be performing compensation reviews.

This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing.

This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.

This FINRA regulation based training will discuss how to create social media policies and implement for compliance and enforcement to avoid fines and disciplinary action for regulated companies. It will also discuss FINRA Notice 10-06 (issued Jan 2010), FINRA Notice 11-39 (issued August 2011), and SEC guidance (issued January 2012).

This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.

This 3-hr virtual seminar on HIPAA Security Policies and Procedures will show how you can comply with the extensive requirements for policies and procedures in the HIPAA security regulation.

This 6-hr virtual seminar will focus on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. It will also cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in South Korea.

In this 90-minute training you will learn more about SSAE 16 (formally known as SAS 70), SOC 1, SOC 2 and SOC 3 reporting, how to choose the right report for your organization and how to get ready for the attestation.

This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.

This Recruiting on a Limited Budget training will cover costs involved in the recruiting process and indicate areas that can be reduced or eliminated by deviating from the traditional methods used. It will focus on alternative methods to attract and find excellent hires at a lower cost.

This 90-minute OSHA Recordkeeping training class will incorporate the lessons learned from OSHA’s recent Interpretation Letters into the existing OSHA recordkeeping analysis as well as OSHA’s current Frequently Asked Questions. In this interactive program, OSHA recordkeeping scenarios will be used so that the rules articulated in the recent Interpretation Letters can be applied to real-life factual situations that arise in your work environments.

This HR Audit training will help you assess your organization's risks and discusses the use of HR audits as a continuous audit process that strengths internal controls, provides assurance of compliance, and evaluates outcomes.

This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.

This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.