FCC 740 and When to Disclaim
Alvaro Gutierrez
90 Min
Product Id: 703918
This training program will detail the functions of the Federal Communications Commission (FCC) and the Telecommunications Certification Body (TCB). It will breakdown the contents of the FCC Form 740 and offer guidance for effectively completing the form.
Affordable Care Act New Tax Penalties: Impact on Individuals and Employers
Cherie Hennig
120 Min
Product Id: 703686
This webinar will instruct participants on the new penalties issued to individuals and employers who lack coverage altogether or whose healthcare coverage fails to meet Affordable Care Act (ACA) standards. Attendees will also learn how to compute the required annual payment, i.e., the shared responsibility payment. This two-hour webinar will focus on requirements set forth for individuals and employers filing the new form 1095-C.
How to Conduct an Internal Investigation - Vital Piece of EEO Compliance
Gayla Sherry
60 Min
Product Id: 703826
No two investigations are the same – even a seasoned veteran who has handled discrimination complaints and conducted internal investigations can still benefit from a deeper understanding of how to ensure EEO compliance. The risk of not properly conducting an investigation is substantial in terms of fines, penalties and settlements, but also court costs and deterioration in the organization’s reputation. This webinar will present plain language ideas for conducting investigations.
Don't be Blindsided by ERISA: Understand Your Fiduciary Responsibilities to Your Health and Retirement Plans
Steve Flores
60 Min
Product Id: 703522
This webinar will focus on the key elements that employers need to know in order to avoid potential fiduciary liability under Employee Retirement Income Security Act (ERISA). It will cover who is a fiduciary, the responsibilities of fiduciaries and how to implement safeguards to reduce the potential for ERISA liability.
Fraud in Clinical Research
David Lim
60 Min
Product Id: 703899
This training program will instruct attendees to better understand ethical and legal requirements when conducting medical/clinical research and study. The webinar will focus on what/how to identify, address and prevent fraud in medical research.
FDA vs. EU Inspections - Getting Prepared and What are Differences
Marie Dorat
75 Min
Product Id: 703516
This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products
Dev Raheja
60 Min
Product Id: 703898
This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.
Export to Mexico Documentation and Procedures
Rossano V Gerald
90 Min
Product Id: 703917
This training program will detail appropriate multiple trade agreements that importers and exporters require when conducting trade transactions, focusing particularly on trade requirements and procedures while exporting to Mexico. The webinar will provide import compliance materials that examine U.S. Customs and Border Protection regulations for record keeping that can be used in the international logistic arena.
Common Pitfalls in Wage and Hour Compliance
Gayla Sherry
60 Min
Product Id: 703913
This training program will offer an overview of the Fair Labor Standards Act (FLSA) which is the guiding law pertaining to classification, deductions, travel time, not tracking hours worked and misclassifying independent contractors. It will also focus on leading wage and hour violations. Recent case histories will also be reviewed for emphasis.
Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance
Michael Walsh
60 Min
Product Id: 703466
This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.
Building an Effective BSA/AML Compliance Program
Armen Khachadourian
60 Min
Product Id: 703864
The prevention of money laundering is a key focus of regulatory authorities in developed countries around the world. Money laundering regulations are designed to inhibit the movement of funds derived from criminal activity and to restrict the availability of money to fund terrorist activities. This training program will detail the historical context of AML regulations, best practices to implement an effective AML program, and reporting guidelines for the same.
Health Canada's Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Foods and Beverages
Sara Zborovski
60 Min
Product Id: 703852
Health Canada takes an active role in ensuring compliance with the regulatory requirements for advertising, marketing and selling food in Canada. In addition to rules to ensure the safety of food for Canadians, there are strict rules to ensure that manufacturers do not make false or misleading representations about food to Canadian consumers. This training program will introduce participants to various key legislations and its regulators, and discuss regulatory measures to ensure compliance.
Clinical Trial Liability Lawsuits
Jonathan Mcdermed
60 Min
Product Id: 703645
This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.
ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System
John G Lanese
90 Min
Product Id: 701441
This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.
Compliant and Effective Recruiting Including Compliance Challenges with Passive Candidates (NJ, PA, DE and NY State Regulations)
Deborah E Watson
90 Min
Product Id: 703693
This course will highlight the key components of an effective and compliant recruiting process and discuss federal and state regulations that impact recruiting. The webinar instructor, a senior human resource executive and business strategist, will also analyze the challenges in passive candidate recruiting.
Qualified vs. Non-Qualified Deferred Compensation Plan - 409A, ERISA and Govt. Filing Requirements
Steve Flores
60 Min
Product Id: 703666
This presentation will provide you with a good foundation to help you design and administer these nonqualified deferred compensation plans in a legally compliant manner. You will learn the differences between qualified and non-qualified plans, ERISA, 409A & Govt. filing requirments.
HIPAA Security and Breach Notification Rules - Protecting Security of PHI
Jim Sheldon-Dean
90 Min
Product Id: 703869
Staying HIPAA compliant entails ensuring you have the right policies, procedures, and documentation, and have performed the appropriate risk analysis of confidentiality, integrity, and availability of the electronic protected health information (PHI). This course will discuss how to create the right breach notification policy for your organization and how to follow through when an incident occurs. In addition, a policy framework to help establish good security practices will be presented.
Global and FDA Regulation of Electronic Cigarettes
Azim Chowdhury
60 Min
Product Id: 703849
The global regulatory environment for tobacco, e-cigarette and e-liquid products is rapidly evolving as legislators and regulators in the United States, European Union and Asia attempt to understand the health and safety concerns presented by these novel products, and develop appropriately tailored laws and regulations. This training course will present an overview of e-cigarette regulations in Asia, the European Union and around the world. It will also detail the key provisions of FDA’s deeming regulations.
Laboratory Investigation Out-of-Specification Results
John G Lanese
90 Min
Product Id: 701697
In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation.
Do You Really Need To Do A Recall? If So, What Is Required?
Cheryl Wagoner
60 Min
Product Id: 703895
This training program will provide practical pointers on documenting the recall decision. Recall can be a very costly process for a manufacturer. It is really important from a regulatory perspective to properly document the decision process whether a recall is necessary or not. The new guidance can help provide some direction in making the decision. Though guidance documents are not binding, they do tend to reflect the current thinking of the FDA. Beyond the guidance, the webinar will also illustrate best practices for documenting the recall process in the event that you determine a recall is warranted.