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Courses

  • 121 Request Info

    Webinar on Optimizing Target Weights for Foods and Beverages

    This training program will elaborate factors affecting the target weight decision and help determine the tolerable risks of under-filling and the costs of over-filling. Attendees will gain an understanding of process stability and process capability concepts and methods for process optimization. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/OPTIMIZING-TARGET-WEIGHTS-501306/APRIL-2016-ES-TRAININGREGISTRY
  • 122 Request Info

    Webinar on FSMA Final Rules - Foreign Supplier Verification Program (FSVP) for Food Importers and Accredited Third-Party Certification

    This 60-minute webinar will offer an overview of the Foreign Supplier Verification Programs (FSVP) and the accredited third party certification rules identifying scope, key requirements and compliance dates or implementation dates. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FSMA-FINAL-RULES-501304/MARCH-2016-ES-TRAININGREGISTRY
  • 123 Request Info

    Conference on 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.
  • 124 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
  • 125 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
  • 126 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
  • 127 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
  • 128 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.
  • 129 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.
  • 130 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.
  • 131 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.
  • 132 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.
  • 133 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.
  • 134 Request Info

    Marketing Products without Getting Hammered by FDA

    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.
  • 135 Request Info

    Seminar on Food Safety - Food Defense

    Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to. These requirements mandate FDA's action in the area of Food Defense, and penalties continue to go higher and higher. With the associated costs related to oversights and recalls, Food Defense is an important economic aspect of any organization. This session is designed for food manufacturers, packagers and handlers and is focused towards helping both domestic and foreign entities in ensuring compliance with being secure and remaining compliant to FDA regulations. This session will cover the security and safety requirements of FSMA, particularly in the context of Food Defense, and will highlight FDA action taken to date in this area.
  • 136 Request Info

    Leadership Certification Training: Transportation Food Safety and Quality for Shippers, Carriers and Receivers

    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.
  • 137 Request Info

    Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.
  • 138 Request Info

    Food Safety - Food Defense

    This session is designed for food manufacturers, packagers and handlers and is focused towards helping both domestic and foreign entities in ensuring compliance with being secure and remaining compliant to FDA regulations. This session will cover the security and safety requirements of FSMA, particularly in the context of Food Defense, and will highlight FDA action taken to date in this area.
  • 139 Request Info

    Tougher Import Rules for FDA Imports in 2015

    FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. A number of factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities.
  • 140 Request Info

    The U.S. FDA'’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food by Karl M. Nobert

    Who will Benefit: Pet Food Industry Representatives Regulatory Affairs Professionals Consultants Scientists Research Analysts State Department of Agriculture Officials Investment Analysts and Venture Capitalists Pet Food Formulators, Manufacturers, Labeler and Retailers Foreign Manufacturers Importers / Exporters Ingredient Producers Financial analysts and investors focusing on the pet, pet food, animal health and companion animal markets