Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Analytical laboratory audit training/webinar will show how to implement a GXP program and how to audit this program.

This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This Medical device training will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action.

This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

This CAPA training/webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device and it will mention the Differences between the FDA's approach and the ISO approach.

This JPAL (Japanese Pharmaceutical Affairs Law) training will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan.

The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

This water compliance training/webinar covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization.

In today’s evolving GMP landscape, staying ahead of human error trends is critical. This webinar addresses cutting-edge strategies for managing human error as a systemic challenge—not just a behavioral issue. Gain insight into how the latest tools, including AI and predictive analytics, are reshaping compliance, training, and error prevention across regulated industries.

This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.

This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).

This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

This Medical device training will provide valuable assistance and guidance to all medical device companies and user facilities involved in medical device vigilance. A revised medical device guidance document on post marketing vigilance (MEDDEV 2.12-1 rev 5) was published in April 2007 by the European Commission and came into force on January 1, 2008. The 2007 update provides more guidance than the previous version, introduced in 2001, and includes new reporting terminology and concepts such as periodic summary reporting and trend reporting. In addition, the terms advisory notice, near incident, and recall have been eliminated or replaced.

The vigilance guidelines are part of a set of European medical device guidelines, known as MEDDEV documents, which are intended to promote a common approach by all involved parties on interpreting and complying with the Medical Device Directive. MEDDEV includes new reporting terminology and concepts such as “periodic summary reporting” and “trend reporting.” In addition, the timescale for reporting incidents is stricter. The terms “advisory notice,” “near incident” and “recall” have been eliminated or replaced by the new terms. As with the 2001 version, the new version refers to the incorporation of the views of the Global Harmonization Task Force (GHTF) into the European context.