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Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory

This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data,

Enforcement of HIPAA regulations is being stepped up and new fines and penalties make being ready for an audit in advance essential.

This webinar provides step by step instructions on how to design and manage a CAPA system that meets and exceeds compliance requirements

FDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy

This GCP compliance in Clinical Trials training aims to provide an overview of the parameters critical in ensuring GCP compliance and in doing this, will translate GCP in a more practical, applied sense.

This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations,

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

In this GCP compliance webinar learn how to prevent and handle protocol deviations and violations

This 6 hour training course will cover areas of human resources for which supervisors are responsible, such as hiring, performance management, counseling, discipline, terminations

This Employee Motivation training will demonstrate proven strategies for motivating employees to make lifestyle changes, improving employee engagement and wellness.

This 6 hour training course will provide proactive measures and best practices for handling human resources policies and practices legally and effectively

This webinar will explain the different types of Personnel Files. Attendees will learn about the types of personnel files that need to be separated from other types, and those that require separate security measures.

This OFCCP training will provide a comprehensive primer on affirmative action, its key principles, and current framework for developing compliant programs.

This Child Support Garnishments training will help you understand the requirements to compliantly and effectively handle garnishment orders and withholding.

This webinar will explain the hidden dangers in writing an employee manual or handbook. Learn the Do's and Dont's and how to make its content binding on your employees.

This HIPAA risk analysis webinar will discuss how to go about a Risk Analysis for HIPAA, how to use Risk Analysis to prioritize your security efforts and how risk Analysis can help you win stimulus funding and avoid penalties.

This webinar on patient information security and payment card rules will detail what the PCI Data Security Standard requires for protection and how the PCI DSS relates to the HIPAA Security Rule.

This webinar on Wellness Programs will show you how to distinguish between real and fabricated wellness reports by identifying phony metrics, and choose a wellness program that best fits your organization.

This webinar on Physician Quality Reporting System for Anesthesia Claims webinar will help you understand the importance of reporting PQRS for anesthesia services, the documentation involved

This Care Management Outcomes training will show why the savings numbers are usually made up and how you can get the most valid outcomes from your carriers or care management vendors.

The BRC GFSI audit is a risk assessment driven program.This webinar will guide the manufacturer through the process of conducting and documenting the required risk assessments.

This Food Safety Modernization Act training will provide an introduction to and summarize the key provisions of FSMA. The implementation schedule and potential expectations for food manufacturers and processors will also be outlined.

This HACCP Validation and Verification webinar will serve as an in depth guide to the methodologies to be employed in HACCP validation and cover key steps to meet verification requirements.

This Food Recall training will help you create a robust process for planning and conducting a food recall and crisis communication.

Attend this webinar to learn strategies and practical examples for document control to comply with GFSI audits and for legal compliance.

This training on UK Bribery Act will help you understand its requirements and how it will impact your organization. Learn how to identify areas of risk, proactively mitigate them to avoid significant fines and loss of reputation.

This 4 hour virtual seminar will focus on the challenges associated with smaller entities when designing, building and/or assessing a risk management program and associated system of internal control.

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel.

This 4hr training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors sections (classes of solvents,options for describing levels,analytical procedures).

This USP 1226 webinar training will discuss the requirements of USP 1226, what are FDA expectations related to method verification.

This Disinfection and Cleanroom Cleaning training will teach you how to choose the best disinfectants, know the different performance parameters of disinfectants, methods to qualify disinfectants, writing and executing cleaning procedures.

This 90 minute webinar will help comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.

Attend this webinar to understand various sterilization processes and their general compatibility to various types of challenging medical products.

This 6-hr webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.

This 4-hr Latin America Regulatory compliance requirements 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 4 hour training will focus on best practices in design reviews and show how you can add high value to your products and processes by improving the performance while reducing the life cycle costs significantly.

This medical device quality systems training will show how you can design and maintain your quality system to meet requirements to target the US, Canada and EU.

This webinar will show how you can perform meaningful, results driven 510(k) / change analysis activities and reporting so as to satisfy FDA requirements.

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback.

The seminar will train companies in FDA regulated industries on proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

The seminar will serve regulatory and quality professionals in Medical Device companies by helping them create effective Risk Management and Quality Management Systems.

This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.

This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.

This webinar on safety reporting in clinical trials will focus on the major revisions that FDA made to its IND safety reporting requirements.