Compliance Training Webinars for Regulated Industries

In this Risk management training we will review the concept of Risk Management, its various elements, what is required, and its benefits. How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? The concept of Risk Management and the difference between risk analysis, evaluation, assessment, and management.

The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.

This webinar will provide valuable assistance to all regulated companies that utilize third party vendors that provide products or services to the companies or to the customers or clients of those companies The most critical areas focus on the identification of the need for additional third-party services, development and adoption of the Vendor Management and Oversight Policy, the selection of qualified vendors (including the development of the Request for Proposal and bid process), the contract development and award, ongoing review, and nondisclosure and confidentiality concerns

This webinar will provide valuable assistance to all GSA Schedule contractors. It takes more than a GSA contract number and a sales team to be a successful GSA contractor. It also takes a well-designed and effective GSA compliance program.

In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".

This webinar will provide guidance on how to audit the more difficult areas of a quality management system The applicable ISO 9001:2000 requirements will be examined for each of these difficult areas and then suggestions made on how to more effectively audit them

This Pharmaceutical training examines the system its benefits and its drawbacks and how effective is the system established between the EMEA and the FDA. The authorization of medical products by the FDA is not recognized in the EU. Neither is authorization by the EMEA Recognized by the FDA.

Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.

In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.

This Internal audit training is to align the audit risk assessment, audit ecosystem, audit plan, and audit engagements with the larger organization’s strategy, vision, and values.

This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.

This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.

This Quality compliance training will present and identify ways that your (ISO 9001 8.2.3) process monitoring and measurement tools can Lead your organization to fast and efficient corrections when problems occur.

This Pharmaceutical training starts with the drivers for outsourcing and investigates the importance of measures of success and how they apply in implementing strategy.

This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.

This Internal Audit training will provide valuable assistance to organizations desiring to comply with ISO 9001:2000 and will provide the internal audit functions with methodology and tools to better perform internal audits.

This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.

In this Financial services training will examine the provisions of the PATRIOT Act that affect international financial institutions, along with recent regulations implementing those provisions.