Compliance Training Webinars for Regulated Industries

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.