Conflict Minerals 2014, SEC's Disclosure Requirements: The Past and Future
Lawrence Heim
60 Min
Product Id: 703565
This webinar will provide a thorough understanding of the SEC conflict minerals disclosure requirements. It will help you develop strategies for the next filing covering calendar year 2014.
14 U.S. Code of Federal Regulations Part 13 Investigative and Enforcement Procedures
Mont Smith
90 Min
Product Id: 703526
This Federal Aviation Administration (FAA) compliance webinar will discuss in detail 14 CFR Part 13 investigative and enforcement procedures. It will cover investigative procedures, administrative actions, legal enforcement actions, Rules of Practice for FAA hearings, formal fact-finding investigations under an Order of Investigation, Rules of Practice in FAA Civil Penalty Actions, Civil Monetary Penalty Inflation adjustment, and the Flight Operations Quality Assurance (FOQA) program.
Chargebacks - What can be done to minimize the risk?
Brent Meyers
60 Min
Product Id: 703119
This training will help you understand the concept of chargeback and how they are misused. Learn the best practices to protect your business from the risk of chargebacks.
Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment
Jerry Dalfors
90 Min
Product Id: 703560
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
FDA Regulation of Tobacco Products: The Deeming Regulation - Impact on E-Cigarettes
Azim Chowdhury
60 Min
Product Id: 703107
This webinar on tobacco regulations will discuss FDA regulatory requirements for tobacco products. It will prepare you for FDA’s Deeming Regulations for cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products.
Effective Management of Intellectual Property Records
Charlie Sodano
75 Min
Product Id: 702496
This webinar will show how you can build and maintain research records, that are used to support patent claims, to meet stringent requirements and ensure that they can support in filing patent applications and defend in case of litigation.
Developing and Facilitating Effective Compliance Risk Assessments
Kenneth Barden
75 Min
Product Id: 703530
This webinar will explain various approaches available for assessing risk in a company’s business portfolio. Attendees will learn best practices for conducting risk assessment to evaluate compliance risks, rate them, and prioritize them accordingly. Learn how to implement mitigation measures to reduce any adverse impact.
ISO 22000 vs GFSI (SQF, BRC, IFS, and FSSC 22000): Meeting key Requirements
Mark Kruk
60 Min
Product Id: 703557
This webinar will focus on ISO 22000 Food Safety Management System and its comparison to the Global Food Safety Initiative (GFSI) Standard. It will provide an overview of key requirements and will discuss differences and similarities between both the approaches. It will also address key strategic business factors to consider when selecting a particular approach.
Multistate Handbooks: Multitasking Policies Effectively
Deirdre Kamber Todd
60 Min
Product Id: 703528
This webinar will explain how to develop and maintain a high-quality multi-state employee handbook. It will cover common federal and state issues in multistate handbook drafting including NLRB, EEOC, PPACA, disability, pregnancy and leave.
Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER
David Lilienfeld
90 Min
Product Id: 703479
This pharmacovigilance webinar will provide attendees an understanding of post-marketing drug safety surveillance, its role in lifecycle management, and the practices and regulations governing its conduct. It will describe the structure of the pharmacovigilance world including the ICH, the FDA, CIOMS, MHW, and EudraVigilance.
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.
Current Trends in FDA Inspections
Michael Ferrante
90 Min
Product Id: 703485
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.