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

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.

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.

This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance

This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.

This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.

This Clinical trial training will focus on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process.

This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.

This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.

This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.

In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.