Compliance Training Webinars for Regulated Industries

This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.

This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).

This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.

What credit professionals need to understand to carry out their responsibilities and duties to ensure Sarbanes-Oxley compliance. The Sarbanes-Oxley Act of 2002 makes company executives of publicly traded US companies personally and criminally responsible for the accuracy and reliability of the financial disclosures of their companies.

Learn how to comply Sarbanes Oxley compliance in a cost-efficient manner. Many have questioned whether the Sarbanes-Oxley law requirements can be met in a cost-efficient manner. Absorbing the first-year lessons — and, going forward, is a challenge facing all public companies as they prepare to meet quarterly and annual reporting requirements. And further challenges will arise as new compliance issues emerge and PCAOB regulations evolve.

This presentation will review the ISMS and architectural considerations that need to be addressed. An ISMS can help an organization effectively and efficiently manage information security related risks.

The core of the presentation will be an in-depth look at Section 404 and the COSO Guidance used by most organizations for compliance. We will describe the SOX legislation including the creation of the Public Corporation Accounting Oversight Board (PCAOB) and key sections of the Act.

The training supports SOX Compliance (particularly Section 30 as it pertains to anonymous hotlines), and conforms to key criteria of the revised US Federal Sentencing Guidelines. Know how to promptly and effectively REPORT incidents of fraud or suspicious conduct.

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.

In this webinar, ISO certified lead auditor for 27001, Ed Moyle, and Diana Kelley, Partner at Security Curve, will explain how organizations can use the ISO standards as a baseline for their security and risk management program. This webinar will provide valuable assistance to all companies are building and maintaining information security management systems.

In this webinar we will cover the legal principles developed by the common law concerning employee privacy, the major anti-discrimination laws.

Regulatory expectations for reporting in multi-company development and marketing programs.

In this presentation each on the categories and requirements of the PCI/DSS standard 1.1 will be compared to settings within the Virtualization configuration of a VMware ESX Server 3.x machine. Security professionals who wish to have a closer look at the security settings possible on a virtualization host for consideration when crafting detailed policies.

The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.

AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.

This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.

This presentation will present the major items that your company’s Technology Control Plan and Compliance program must contain. Emphasized are best-practice strategies to make your program compliant and effective.