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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.
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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.
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Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Mukesh Kumar
90 Min
Product Id: 703422
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.
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Regulatory Compliance for Food Supplements in the EU - Registration, Labeling, Acceptable Marketing Claims
James Russell
90 Min
Product Id: 702545
This 90-minute webinar will discuss regulatory requirements for food supplements in the EU. It will cover regulatory structure, registration, labeling, supplement ingredient criteria/safety and advertising considerations. Borderline products such as medicinal and herbal products will also be discussed.
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FDA Regulatory Actions: It's Not Just about Warning Letters
Fredric Richman
60 Min
Product Id: 703344
This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.
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Food Safety and Continual Improvement: Beyond Corrections and Audits
Oscar Rodriguez Gonzalez
60 Min
Product Id: 703361
This webinar will present a proactive approach to improve food safety management systems that go beyond corrective actions to deviations and findings from external audits. It will focus on the continual improvement methodologies to speed up or optimize processes, solve problems and manage complexity.
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Supplier Quality Management: Implement it Now or Pay for it Later
Les Schnoll
90 Min
Product Id: 703357
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
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Are you prepared for a regulatory audit from FDA or any other regulatory body?
Philip Russ
90 Min
Product Id: 703355
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
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3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity
Karl M. Nobert
3 hrs
Product Id: 703269
This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.
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Managing Products in California: Compliance with Prop 65, Green Chemistry and the Rigid Plastic Packaging Act
Lee N Smith
60 Min
Product Id: 703266
This webinar will provide an in-depth understanding of California specific laws, affecting food and other product manufacturers and marketers, such as the Prop 65, the Green Chemistry Initiative, and the Rigid Plastic Packaging Act. We will discuss these laws, how to comply with them and avoid litigation.
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Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations
Anthony Pavel
60 Min
Product Id: 703033
This training on marketing of beverages, fruit juice and sports drinks will focus on FDA’s labeling regulations and requirements, FTC enforcement of advertising claims, and recent developments in consumer class action lawsuits involving beverages. Attendee will learn best practices to ensure compliance with FDA and FTC regulations.
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Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.
Karl M. Nobert
90 Min
Product Id: 702508
This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.
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Bacterial Contamination in a Product Facility
Richard Anfuso
60 Min
Product Id: 703217
This training on food safety compliance will provide the attendees with the knowledge of how food borne pathogens enter a food plant, expand its presence within the facility and contaminate the products. Attendees will learn the best practices for minimizing the presence of these pathogens in the food plant.
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An Approach to Validating Allergen Cleaning Procedures
Ian Ramsay
60 Min
Product Id: 702685
This training on allergen cleaning will cover a rigorous approach to validating cleaning procedures or where cleaning is not possible supporting the need for a ‘may contain’ claim.
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FSMA Update - Overview Three Sweeping Rules: Foreign Supplier Verification Program Rule, Third Party Auditor Accreditation Rule, Preventive Controls Rule and GMPs for Animal Food/Feed Rule
Marc Sanchez
60 Min
Product Id: 703193
This webinar will cover the basic mechanics of new rules under the Food Safety Modernization Act (FSMA); Foreign Supplier Verification Program rule, Third Party Auditor Accreditation rule, Preventive Controls rule and GMPs for Animal Food/Feed rule.
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Class Action Risks in Food Labeling: Changing Regulation, Consumer Litigation
J Mason Weeda
60 Min
Product Id: 703184
This webinar will discuss recent consumer class action suits, their evolution and the trends in consumer claims and provide suggestions to help you avoid these types of cases.
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Preparing for a US FDA Food Facility Inspection
Edwin V Rivera
60 Min
Product Id: 703155
This webinar will provide an update on the U.S. FDA's new Food Safety Modernization Act, its inspectional process and discuss how to prepare for an FDA inspection.
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U.S. Food and Beverage Labeling Regulations
Mark Prinz
60 Min
Product Id: 703074
This webinar on U.S. FDA labeling regulations will highlight key food, beverage, and dietary supplement labeling requirements, including alcohol labeling rules.
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Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality
Mukesh Kumar
60 Min
Product Id: 702805
This medical foods regulatory compliance training will explain the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be provided.
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How's your HACCP? Developing a HACCP program that is effective, appropriate and compliant
Sean McCarthy
75 Min
Product Id: 703069
This food safety training will review what is takes to build an effective HACCP plan, validate and verify it. It will discuss the prerequisite programs needed to even start the process, recordkeeping requirements, to who needs to be involved in the process and why.