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Courses

  • 201 Request Info

    Webinar on Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

    The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed pre-market approval process, has resulted in a flurry of companies creating and marketing their own dietary supplements in the United States. With FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.
  • 202 Request Info

    Webinar on FDA Regulation of Dietary Supplements

    FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
  • 203 Request Info

    Webinar on Quality Control for Analytical Materials used in Microbiology Laboratories

    To develop appropriate Quality Control Practices and acceptability criteria to evaluate the performance of analytical materials for laboratory use Upon completion of this session, attendees will learn: To understand intrinsic and extrinsic factors which can affect the performance of culture media, test kits, reagents and other analytical materials To identify Control Points (CP) and Critical Control Points (CCP) in media quality assessment.
  • 204 Request Info

    Webinar on Prepare Your Company to Meet the Final FDA FSMA Preventive Control Rule Requirements for Environmental Monitoring

    In this session you will learn about the newly finalized FDA FSMA rules covering environmental monitoring that cover the food supply chain. Environmental monitoring plays a critical role in the development and implementation of a validated preventive control plan such as those required in the FSMA preventive controls rules. We will discuss costs related to sampling and testing for bacteria and other hazards in different environments such as the farm and in transportation processes. It is important to learn about different technologies for different applications and the data required by the FDA and the data used to manage operations.
  • 205 Request Info

    Seminar on New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods Los Angeles, CA

    In this two day workshop conference you will learn the legal requirements, how to develop a company plan that meets FDA and your customer requirements. You will review and learn how to establish appropriate temperature monitoring, sanitation, container test and traceability, training and data reporting procedures. New low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing will be presented. The session will also review the future of transportation food safety in light of new and evolving technologies. References to upcoming technology providers and Internet links to detailed information will be provided.
  • 206 Request Info

    Safe Production of Meat Products

    This seminar is designed for those that want to be involved with the production of safe meat products. Material to be discussed will provide participants knowledge of how sanitary practices can contribute to the production of safe meat products. Knowledge will be provided about contamination responsible for spoilage and foodborne illness and how hygienic practices can enhance the safety of meat products. Valuable knowledge will be provided about how to more effectively enhance hygiene and conduct effective sanitation practices during production and recommended procedures for efficient and effective cleaning. Also, participants will receive instruction about how to evaluate the effectiveness of a sanitation program. Because of the importance of Hazard Analysis and Critical Control Points (HACCP), participants will learn how to incorporate HACCP into the production operation including plan development, implementation, and assessment.
  • 207 Request Info

    Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls

    Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits. According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that the controls are effective, take appropriate corrective actions, and maintain records documenting these actions". This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls. You will develop a basic plan during this training and have it checked by the instructor.
  • 208 Request Info

    Food Safety and Defense: Key Factors to Safely Manufacture, Package and Handle Food Products

    This Seminar will focus on Food Defense and 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.
  • 209 Request Info

    Webinar on FSMA Final Rules for Preventive Controls for Human and Animal Food

    This 90-minute webinar will offer a general overview of the "7 pillars" of FSMA but will focus on the following two key elements: The preventive control rules for human and animal food. Key requirements and concepts will be discussed such as Hazard Analysis & Risk Based Preventive Controls (HARPC), "qualified individual" and timeline for compliance. The webinar will also address some of the cGMP updates including mandatory training requirements for facility employees. In order to provide guidance to the food sector, the presentation will also describe how "GFSI" prepares industry towards FSMA compliance. The Safe Quality Food scheme will be discussed since it is the global food safety standard the most widely used in the US. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/FSMA-GUIDELINES-501214/JAN-2016-ES-TRAININGREGISTRY
  • 210 Request Info

    St. Louis Conference on Safe Production of Meat Products at Missouri

    This seminar is designed for those that want to be involved with the production of safe meat products. Material to be discussed will provide participants knowledge of how sanitary practices can contribute to the production of safe meat products. Knowledge will be provided about contamination responsible for spoilage and foodborne illness and how hygienic practices can enhance the safety of meat products. Valuable knowledge will be provided about how to more effectively enhance hygiene and conduct effective sanitation practices during production and recommended procedures for efficient and effective cleaning. Also, participants will receive instruction about how to evaluate the effectiveness of a sanitation program.
  • 211 Request Info

    Webinar on How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you

    Overview: An FDA investigation can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown. Why should you attend: How would you respond to an FDA investigation? It could be a 483 observation, a warning letter, or a Consent Decree, all of which will impact how you carry on your business while under investigation. Speaker Profile: Drew Barnholtz serves as an outside general counsel and compliance officer for skilled nursing facilities, hospice providers, home health providers, physician practice groups, durable medical equipment companies, pharmaceutical and start-up businesses. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1j8Ha7T
  • 212 Request Info

    Webinar on FDA Regulation of Medical Device Software

    Overview: The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). Why should you Attend: To gain a fundamental understanding of FDA regulation of medical device software. Areas Covered in the Session: Definition of medical device software FDA's medical device software regulatory scheme Software validation Level of concern Speaker Profile: Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1MCN2jf
  • 213 Request Info

    Webinar onFDA Regulation of Combination Products

    Overview: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Areas Covered in the Session: Definition of combination product FDA Regulatory Pathways Primary Mode of Action User Fees Who Will Benefit: Regulatory professionals working in the field of combination products Speaker Profile: Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1LLEDvl
  • 214 Request Info

    Webinar on Verification or Validation of Methods in Food Microbiology

    Overview: Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Areas Covered in the Session: The difference between method validation and verification The performance characteristics for method validation Performance requirements for method verification Who Will Benefit: Quality Assurance Managers Laboratory Technicians Laboratory Managers Speaker Profile: Michael Brodsky has been an Environmental Microbiologist for more than 41 years. He is a Past President of the Ontario Food Protection Association and AOAC International. He serves as Chair for the AOAC Expert Review Committee for Microbiology. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1L1vuOz
  • 215 Request Info

    Seminar on Complaint-Handling, MDR and Recall Management at Los Angeles, CA

    Overview An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution.
  • 216 Request Info

    Leadership Certification Training: Transportation Food Safety and Quality for Shippers, Carriers and Receivers at San Diego, CA

    Overview: In order to qualify as a food safety transportation leader, you will need to understand what and how to implement FDA FSMA rules on the sanitary transportation of human and animal foods. This training will include detailed information on these rules and will include food safety topics generally established by FSMA to assist in your company's approach to transportation tools, load, unload, driver and transportation food safety practices across shippers, carriers and receivers. Over 84,000 businesses will be impacted by these new rules. The shift from "transportation food safety guidance" to "rules" means that the FDA now has enforcement powers that did not previously exist and these powers impact food importers and exporters as well as all food shipments intended for food consumed in the United States. We will cover how you can assess your current operations and build a plan and complete system designed to meet customer and FDA FSMA requirements.
  • 217 Request Info

    Seminar on Clinical Drug Development and Approval Process at San Diego, CA

    Overview Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and approvals from the Food and Drug Administration (FDA) website. The outline for the class will include organization of a pharmaceutical company including preclinical, pharmaceutical development, clinical pharmacology, clinical, and regulatory. Several therapeutic areas will be used in examples.
  • 218 Request Info

    Validation and Part 11 Compliance of Computer Systems and Data at Zurich, Switzerland

    Overview Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
  • 219 Request Info

    Marketing Products without Getting Hammered by FDA at Zurich, Switzerland

    Overview With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion.
  • 220 Request Info

    Seminar on Marketing Products without Getting Hammered by FDA at Sydney, Australia

    Overview With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion.