Food and Dietary Supplements Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will discuss regulations that impact Natural Health Products in Canada. It will detail how to verify the products’ compliance with published regulations. It will also detail requirements for registration, labeling and acceptable marketing claims.

FSMA has modified the traditional position that FDA would not collect fees from food companies to allow collection of the agency’s costs of remedying certain violations of food law. This training program will offer a background on FDA imposition of fees on food producers, the fee amount, and how it applies to small businesses.

In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.

This training program will help attendees prepare to work within Food Safety Modernization Act guidelines and understand how they will be impacted, and how to adapt. The program will also offer best practices to make your supply chains meet the rising demands of consumers.

This training program will discuss what is a NCC (Nutrition Content Claims), a GLHC (General Level Health Claims), a HLHC (High Level Health Claims), and the conditions for making these claims. Attendees will understand the conditions on the types of foods that can carry nutrition content and health claims and the process to self–substantiate a food health relationship and requirements for FSANZ notification.

The Health Insurance Portability and Accountability Act (HIPAA) rules and regulations clearly state that an impermissible use or disclosure is presumed to be a breach. Therefore, any such incident triggers the required notifications. However, if an organization performs a risk assessment and shows why the incident is not a breach, the required notifications would no longer apply. This training program will focus on how to perform an effective risk assessment that can not only reduce the administrative burden of dealing with presumed breaches, but also help an organization meet other criteria such as those that exist in the Office for Civil Rights HIPAA audit protocol.

This training program will discuss global considerations for supplements and nutritional products as well as the country/region specific considerations for them. It will also elaborate healthcare authorities’ outlook, global expansion challenges, product classification, and marketing challenges in the industry.

This training program is designed for food safety practitioners who are preparing for implementation of the Preventive Controls Rule, and require assistance in effectively managing allergens. Those who have an existing allergen control program realize that though a plan is in place, compliance and ongoing monitoring is essential for success. Operations which have formally relied upon the standards as set forth by certification bodies may wish to reconsider their approach based upon the finalization of the PC Rule.

This training program is designed for food defense and food safety practitioners who are preparing for implementation of the Intentional Adulteration rule. Those who have existing Food Defense Plans should understand how the vulnerability assessment requirements may go beyond most existing food defense plans and what considerations will be needed to comply with the rule. Operations which have relied on the FDA supplied Food Defense Plan Builder software tool should know the limitations of the existing tool, and how to overcome them, and who is qualified to do so.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

This food defense webinar will detail what an organization needs to have in place in order to safely manufacture, package, and or handle food products. It will cover a broad range of production types, facilities, and the transportation of goods. This webinar will highlight key areas of the organization that need to be controlled to ensure that intentional contaminants do not enter the product by potential threats.

The program will discuss the practical development of an adequate monitoring program optimized to fit the Intentional Adulteration Rule. Attendees will learn the difference between monitoring, verification and validation. The program will review the existing Food Defense Plan Builder tool including its limitations and some possible changes. In the absence of a provided tool, the program participants will be shown how to create an effective monitoring program, and the documentation required to support it.

This training program will focus on understanding and accepting our respective responsibilities to help ensure that our food supply is safe by pursuing a food safety culture locally, nationally and globally.

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.

This Food safety training will provide valuable guidance to management, supervision, and quality staff that are involved with record keeping for product and ingredient traceability and recall.

This Bioterrorism act training will provide the attendee a clear understanding of what is expected, how an investigation will proceed, and how to keep records that will minimize the impact of an incident.

This HACCP training will explain the FSIS regulations and policies program requirements.

This Food Safety and Inspection Service (FSIS) training will guide you through the different levels of enforcement that FSIS utilizes.

This Food safety compliance training will explain the CCP Decision Tree and help you understand the principles behind each question. We will review various food processing steps in a variety of situations to determine whether they are CCP’s. What is the thought process in determining a CCP? Can it be done consistently? What criteria are used? Are some processing steps always CCP's e.g. heating? If not, why? One thing to remember is the importance of analyzing the hazards at each step very carefully. The more clearly the hazards are described (including equipment failures, personnel errors etc) the easier it will be to find the CCP.