SOX Web-based Seminars

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards.  more...

Webinar on Pharmacovigilance Audit - Webinar by GlobalCompliancePanel This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices. The course will cover all aspects of drug safety and pharmacovigilance compliance including the  more...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/ DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products  more...

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel Change control in IT environments has been a focus for a decade or so, especially for application changes. In this webinar you will learn: The components of a strong change management program, including specifics on configuration management, system hardening, and compliance review. In addition, the types of logging and monitoring required by the PCI DSS will be discussed which will enable  more...

Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in the  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements  more...

Defining Architecting and Managing Risk Assessments - Complinace Webinar by GlobalCompliancePanel Risk Assessments are a vital tool in the Risk and Compliance management arsenal. Unless a business knows at any given time what its exposures are, and how they are evolving, the mitigation steps to manage its risks can never be in lockstep with prevailing circumstances or conditions. Concise Risk Assessments are a vital component of any successful Risk based initiative. Intelligent enquiry is  more...

Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel The Learning Objectives of this presentation include: * Recognize regulatory (FDA/ EU) requirements for batch records and batch record review * Modeling best practices of a technical review of batch records * Discover the essentials of batch record reviewer qualifications and training * Acquire confidence in determining the final decision or recommendations. * Establish  more...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

How to Survive a DEA Audit - Compliance Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these  more...

Conduct Your Own Risk Assessments Following ISO Standard 3100031010 It is essential for any organization to first determine its risk appetite and then to conduct its own self assessment as to its actual risk exposure. The new ISO risk standards provide a straight forward method that is suitable for larger and smaller organizations alike. Aligning your risk appetite with your actual risk exposure can help rationalize and prioritize key business opportunity  more...

Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety - Webinar by GlobalCompliancePanel In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device. During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give  more...