
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.

Validation of Analytical Methods According to the New FDA Guidance
Dr. Ludwig Huber
75 Min
Product Id: 703623
This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods.

Introduction to Tariff Classification: Are Your Products Classified Correctly?
Reynaldo Roman
60 Min
Product Id: 703889
This training program will discuss why the role of Harmonized System (HS) classification is crucial to the import process. The HS classification is a multipurpose, global classification tool developed and maintained by the World Customs Organization. It is used by customs agencies around the world to classify the products entering a country’s borders and forms the basis for the customs tariff of 179 countries. In fact, most countries consider the misclassification of products to be a trade violation; making tariff classification a major trade compliance issue.

U.S. Payments Landscape - Its Significant Changes and How it Affects Merchants Accepting Payments
Armen Khachadourian
60 Min
Product Id: 703863
Different payment approaches are starting to remove the requirement for a payment card at the point-of-sale (POS), leveraging cloud-based services or mobile devices. This training program will enumerate how significant changes in the U.S. payments landscape are effecting how merchants accept payments.

South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam
Robert J Russell
90 Min
Product Id: 702546
This training on South East Asia regulatory compliance for life science products will discuss the regulatory structure and requirements for compliance with in-country regulations for pharmaceuticals, medical devices, biologics and combination products. This webinar will focus on a high-level composite of requirements in Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand.

Offensive Behavior and Harassment that Violates Title VII of the Civil Rights Act of 1964 - The Supervisor's Role
Kelly Rietow
60 Min
Product Id: 703890
Employee complaints go with the territory when you are a manager. But how do you know when your complaints and concerns may indicate policy violations or illegal behavior? This webinar will help attendees understand the definitions of harassment and offensive behavior, protected classes, the supervisor’s role, and preventing retaliation.

Why Fraud Happens and What to do: Critical Concepts on How to Prevent, Detect and Mitigate Fraud
Lynn Fountain
90 Min
Product Id: 703878
Auditors and financial managers are not expected to have the expertise of forensic investigators, but they should have adequate knowledge of the aspects of fraud and maintain a skeptical mind when it comes to reviewing potential violations. Like internal controls, the economy, and business strategy, fraud continues to evolve and auditors must stay abreast of its root causes. This training program will highlight these root causes and detail suggested mitigation and investigation techniques.

Export Audit Compliance Focused Assessment
Rossano V Gerald
60 Min
Product Id: 703881
This training program will address the export audit compliance procedures that will emphasize the appropriate documentation often used in the country market system and its product competitiveness research methods for conducting trade transactions. It will focus on identifying customers, such as the end users, distributors, and sales agents and examine the compliance procedures within foreign law justification. Finally, the webinar will address the sales documentation and other record-keeping compliance procedures that should be used by the exporter when dealing with customs for particular goods requirements for foreign business environment.

Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal
Rotimi Toki
90 Min
Product Id: 702677
This webinar will provide guidance on how to develop and implement an effective cleaning validation plan, customized for specific scenarios, to ensure that the allergen is removed from the food processing line or equipment.

Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9
Rita Hanover
90 Min
Product Id: 702783
This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study.

Evaluating the Effectiveness of your ERM Program: Risk Assessment, Recognizing Risk Awareness, and Building a Strong and Effective ERM Program
Gary W Patterson
60 Min
Product Id: 703626
This webinar will detail ERM core elements and discuss the basics of risk assessment. Attendees will learn to identify critical risk areas and mange backlog of risk areas as well.