FDA GxP and Best Practices Regulatory Compliance Training - Live Webinars, Recordings & CDs

This social media compliance training for healthcare companies will cover the legal and regulatory requirements governing the use of social media. A scenario-based learning approach will be used to show how to create a successful social media team by selecting members from relevant stakeholders, and prepare social medial policies and procedures.

This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.

This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.

This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

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

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 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.

This webinar on SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors.

This 3-hr virtual seminar on the Electronic Common Technical Document will help you understand the background, technical aspects, document structure, and use of the electronic Common Technical Document.

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

This 5-hr GMP requirements training for Combination Products will help you understand FDA's draft guidance on GMPs for Combination Products and provide practical solutions and tools for revamping your quality system to meet this new paradigm.

This full day GCP training course will provide comprehensive learning on the Good Clinical Practices of Research involving human subjects. It will cover all key areas including recruiting study subjects, the Informed Consent process, Adverse Event Reporting and preventing protocol deviations.

This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.

This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs.

Get a complete understanding of GCP through a comprehensive analysis of GCP official text - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.

This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.

The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.

This FDA GMP (Good Manufacturing Practice) inspection training will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.