Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
John Chapman
60 Min
Product Id: 701003
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Employee Final Settlements: What You Can Do To Achieve Final Finality
Jonathan Evan Goldberg
60 Min
Product Id: 703298
This webinar will focus on techniques and strategies for negotiating employment dispute settlements. Attendees will learn best practices for ensuring finality.
How to Create Legally Compliant Commission Agreements
Stephanie Yang
60 Min
Product Id: 703343
This webinar will focus on the requirements of a commission agreement in California and differences between an earned commission and an unearned commission. Attendees will learn best practices for creating commission agreements for California employees and how to avoid the pitfalls.
Preparing a Qualitative Risk Management Dashboard for your Board GRC process
Kurt Kendis
60 Min
Product Id: 703359
This webinar will explain the fundamentals of a qualitative dashboard. It will discuss the steps in the process necessary to design, develop and implement a risk management reporting dashboard for GRC purposes in a short and efficient time frame.
Food Safety and Continual Improvement: Beyond Corrections and Audits
Oscar Rodriguez Gonzalez
60 Min
Product Id: 703361
This webinar will present a proactive approach to improve food safety management systems that go beyond corrective actions to deviations and findings from external audits. It will focus on the continual improvement methodologies to speed up or optimize processes, solve problems and manage complexity.
Managing the Trial Master File - Considerations for Moving to Electronic TMFs
Eldin Rammell
60 Min
Product Id: 703256
This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.
Mobile Medical Applications: Software Regulatory Requirements
Tim Stein
90 Min
Product Id: 702812
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.
Supplier Quality Management: Implement it Now or Pay for it Later
Les Schnoll
90 Min
Product Id: 703357
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
Travel Pay and Expense Reimbursements - Do You Comply with the Law?
Miles Hutchinson
90 Min
Product Id: 703342
This webinar will explain various laws affecting travel pay and expense reimbursements. Attendees will learn best practices to comply with federal travel regulations.
Are you prepared for a regulatory audit from FDA or any other regulatory body?
Philip Russ
90 Min
Product Id: 703355
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
Conducting a Risk Analysis to Comply with Meaningful Use, HIPAA and HITECH
William Miaoulis
90 Min
Product Id: 703347
This webinar will discuss how to do a security risk analysis to meet the requirements of HIPAA, HITECH and Meaningful Use attestation. It will describe ways for effectively completing a risk analysis at the organizational level, the network level and the application level.
Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance
Laura Brown
60 Min
Product Id: 703336
This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).
Optimize Your Import Contracts for Compliance and Risk Management
Scott Lowden
60 Min
Product Id: 703326
This webinar will provide tools and tips for optimizing imports contracts to ensure compliance and reduce risk. Attendees will be able to review their contracting practices, PO forms and purchasing procedures to make the best use of their advantages as a buyer.
Regulatory Documentation for Clinical Trials
Adam Ruskin
60 Min
Product Id: 703329
This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.
Detecting and Preventing Revenue and Receivables Fraud
Peter Goldmann
90 Min
Product Id: 703318
This webinar will explain numerous types of accounts receivable fraud (A/R fraud). It will provide attendees best practices for detecting and preventing all major forms of this type of fraud.
Purchasing Card Compliance with IRS Guidelines
Brent Meyers
60 Min
Product Id: 702655
This webinar on purchasing card compliance highlights the evolution of IRS involvement in the use of credit cards for business use, more commonly referred to as Purchasing Cards. It will explain changes in the way these transactions are governed so your business can operate optimally in the credit card space.
Anti-Corruption Program including the Foreign Corrupt Practices Act (FCPA)
Robert Brewer
75 Min
Product Id: 703316
This webinar will explain the anti-bribery and accounting provisions of the Foreign Corrupt Practices Act (FCPA) and will also discuss the UK Bribery Act. Learn the best practices for avoiding penalties for FCPA, UK Bribery Act, or local law violations.
All about NAFTA and its Impact if You Have to Abide by It
David Ross
60 Min
Product Id: 703348
The webinar will provide detailed information on how to comply with NAFTA basics such as Harmonized Tariff classification, valuation, Country of Origin determination and marking requirements. Attendees will also learn how to comply with NAFTA’s often complex rules for eligibility thus mitigating the risk of violations that are subject to stiff fines and penalties from US, Canadian and Mexican Customs authorities.
Independent Contractor or Employee - Guidelines to Insure Compliance
Kenneth Sprang
60 Min
Product Id: 703227
This webinar will discuss the criteria used by the DOL, the EEOC and the IRS to distinguish between contractors and employees and how you can avoid mis-classifying employees as independent contractors.
Valuation: How to Determine Customs Value
Reynaldo Roman
60 Min
Product Id: 703304
This webinar will explain the WTO Agreement on Customs value and valuation methods. Attendees will learn how to use the valuation methods to determine Customs value.