
Steps to Design and Develop an Effective Closed Loop Change Control System
Michael Kagan
90 Min
Product Id: 703489
This webinar will discuss how to design an effective change control system – electronic as well as paper-based – with traceability and closed loop verification built into the process.

The False Claims Act (or Whistleblower Act) and Hospital Fraud
Shauna Itri
60 Min
Product Id: 703547
This webinar will provide an overview of False Claims Act (FCA) and will discuss the procedures for filing a FCA case. It will review examples of FCA cases that have been successful and have recovered money for the government and rewarded whistleblowers for reporting fraud.

2014 Current Best Practices for Public Company Management
Barth Aaron
60 Min
Product Id: 703527
This webinar will review current best practices for Boards of Directors and senior management on the issues of Say-On-Pay votes, ISS and other shareholder advisors positions, SEC and exchange positions on independent boards and related regulation and positions.

Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs
George Gasparis
90 Min
Product Id: 703562
This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.

Current Issues in the Regulation of Dietary Supplements
Eric B Alspaugh
90 Min
Product Id: 703556
This webinar will explain FDA regulations and current good manufacturing practices (cGMPs) for dietary supplements. Attendees will learn how to comply with these regulations and avoid enforcement actions.

Transforming the Cargo Clearance Process
Suzanne Richer
60 Min
Product Id: 703264
This Customs and Border Protection compliance training will help the attendees understand the latest CBP developments relating to the entire cargo clearance process and how these will impact import clearances.

Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
John E Lincoln
90 Min
Product Id: 700354
This webinar will help attendees evaluate their existing Quality Management System (QMS) in light of the changes in the FDA's CGMP / QMS enforcement paradigm. Attendees will learn how to document a risk-based QMS at their organization for both compliance and cost savings.

Complying with and Applying Regulator's Rules and Guidance as it Relates to Social Media and Personal Electronic Devices (Financial Services)
Donna Sardanopoli
90 Min
Product Id: 703502
This webinar will discuss FINRA Regulatory Notice 10-06, 11-39 and SEC Social Media Guidance. Attendees will learn how to ensure compliance with all rules, regulations and guidance as it relates to social media and electronic devices.

Changes in US FDA Enforcement
Edwin L Bills
90 Min
Product Id: 701699
This FDA compliance training will discuss major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity.

Giving and Receiving Feedback: How to Create and Improve an Employee Development Plan
Gail Birks
60 Min
Product Id: 703506
This webinar will explain different performance appraisal models and will identify the pros and cons of performance appraisals. Attendees will learn how to create and improve an employee development plan.

How to Discipline and Discharge a Poor-Performing Employee Where a workers' compensation Claim has been Filed: Avoiding Retaliatory Discharge Lawsuits
Jeffrey Weintraub
60 Min
Product Id: 703503
This webinar will explain how to discharge a poor-performing employee where a workers’ compensation claim has been filed. Attendees will learn how to minimize the risks of retaliatory discharge lawsuits when taking adverse action against these kinds of employees.

Understanding CFR Part 210-211 Requirements for Drug Products
Jamie Jamshidi
90 Min
Product Id: 700931
This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. Attendees will learn how to comply with these regulations.

Managing OSHA Inspections and Accident Investigations
Kenneth S. Weinberg
90 Min
Product Id: 702176
This OSHA Inspection and Accident Investigation training will provide practical tips for safety professionals and managers on what the OSHA inspectors will look for, how to respond to a letter of complaint, how employees and unions figure into the inspection equation, and what you must do to expedite the inspection and help resolve issues before they become major problems.

Home Health Intermediate Sanctions: Everything Changed on July 1
Robert Markette
60 Min
Product Id: 703542
This webinar will discuss CMS alternative sanctions for home health agencies and the considerations for CMS imposing these sanctions. It will cover types of sanctions available to providers, how sanctions are imposed, information dispute resolution (IDR), how to obtain an IDR, how an IDR differs from an appeal and much more. It will also discuss incorporating survey and certification issues into your compliance program as a means to avoid citations.

OSHA Laboratory Standard
Randall Charpentier
90 Min
Product Id: 703510
This webinar will provide an overview of OSHA chemical hygiene plan. It will discuss requirements of OSHA’s occupational exposure to hazardous chemicals in the Laboratory Standard (29 CFR 1910.1450), including labeling requirements.

Supplier Qualification Audit, A Risk Based Approach
Yasamin Ameri
60 Min
Product Id: 703477
This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

Review of Major Lending Regulations and Required Documentation
Roy Johnson
90 Min
Product Id: 703496
This webinar will provide an overview of major lending regulations and required documentation to ensure loans are in compliance with the law. It will discuss Regulation Z, Regulation B, Regulation X, Regulation O, Regulation U including Fair Debt Collection Practices Act and Flood Disaster Protection Act.

Integrating Risk Management into the CAPA System
Edwin L Bills
90 Min
Product Id: 700525
This webinar will explain what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes so that they will not run afoul of the FDA during inspections

FDA Guidance: Medical Device Recalls
Angela Bazigos
90 Min
Product Id: 703473
This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.

Successful Export Controls Compliance: How to Conduct a Thorough Due Diligence for Exports to Sanctioned Countries
Suzanne Bullitt
60 Min
Product Id: 703282
This export controls compliance training will focus on Office of Foreign Asset Controls (OFAC) regulations. Attendees will learn best practices for managing due diligence processes for their exports when dealing with sanctioned countries.