Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

Fundamental requirements for process validation in both FDA QSR and ISO 13485. Learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.

This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.

This Medical device training is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.

This Medical device quality audits training review the process used by FDA to perform inspections of medical device manufacturers and will provide advice for quality and regulatory personnel that required providing information to an FDA inspector.

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 Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.

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.

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

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 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 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 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.