Compliance Training Webinars for Regulated Industries

This webinar on handling supplemental pay will help you ensure that your supplemental pay practices are in compliance with the Fair Labor Standards Act. It will review in detail all areas of supplemental pay.

This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.

This 90-minute webinar will review FDA expectations/ requirements for discussing off label uses of medical products on social media, e.g.,Twitter®, Facebook®, etc. We will also discuss key elements of the FDA's new Draft Guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices", Dec 2011.

This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.

This 120-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.

This webinar on HPLC Method Development and Validation will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems.

This webinar will cover Interviewing and Hiring in compliance with employment law and show how you can conduct the selection process with confidence.

This Webinar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.

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.