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Courses

  • 1 Request Info

    2-day In-person Seminar FDA and U.S. Customs Import Rules and Export Traps in 2020

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry 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, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.
  • 2 Request Info

    3-Hour Virtual Seminar on FDA Imports Require Precision in 2019

    Overview: After attending this 3-Hour Virtual Seminar, you will have great understanding of how FDA and Customs and Border Protection (CBP) operate a joint program. Why should you Attend: If you understand FDA's and CBP's import program, your business can operate in a competitive way. If you do not, your customers, foreign suppliers, stockholders will see the consequences and not be forgiving.
  • 3 Request Info

    6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV)

    Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
  • 4 Request Info

    Complying With New FDA FSMA Preventive Control Rules: Planning Valid Preventive Food Safety Controls

    Planning, implementing, verifying and validating preventive food safety controls is where the rubber meets the road in terms of prevention. You and your team can come to this training to collectively develop the food safety plan and defense plans, learn to implement the plan, verify plan implementation, and prove that you are actually preventing food safety problems.
  • 5 Request Info

    Conference about Chemical Safety for Sanitation Workers

    Companies must provide effective chemical safety training for all employees including managers, supervisors, operators and temporary workers. The objective of this presentation is to equip the participants with the basic skills and knowledge to assess chemical hazards in their workplace. The participants will also be presented with basic controls for working safely with chemical detergents and sanitizers used in food processing plants. This webinar is the first step to building a foundation for a successful chemical safety program for sanitation workers. All levels of management and workers need to understand the chemical safety information presented and be aware of the actions to be taken to avoid exposer and risk.
  • 6 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.
  • 7 Request Info

    Control Food Safety and Quality by Compliance4all

    Overview: The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes. For food shippers, carriers and receivers, standardization or upgrade to current practices is critical. For buyers, knowing how to establish standards for your food transporters sets the stage for required supply chain controls. The journey from "Where do we start?" to "We are compliant food safety carriers." begins here and establishes a basis for meeting newly evolving FSMA food safety during transportation requirements.
  • 8 Request Info

    Controls Over Transportation of Fresh Organic Foods

    Overview: National Organic Program (NOP) standards were established in 2002. With almost every type of product now flying the "organic" flag from thousands of farms into hundreds of thousands of restaurants and retail establishments, the likelihood of organic food fraud has grown along with the market. Why should you Attend: Overall food fraud losses are estimated at between $10 and $15 billion annually on a world-wide basis. Today thousands of U.S. companies buy, process and sell organic products. With the continuous expansion of the organic industry, pricing variations and food fraud, companies need to protect the consumer, their industry and brand identity investment.
  • 9 Request Info

    Dietary Supplements CGMPS - 21 CFR 111 Compliance 2018

    Overview: This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Why should you Attend: Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term "dietary supplement", and requires that every supplement be labeled a dietary supplement.
  • 10 Request Info

    FDA Policy and Goals Regarding the 483 Response - 2017

    Overview: Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given.
  • 11 Request Info

    FDA Recalls and Traceability Requirements through Food Processes

    Attend this webinar by John Ryan, you will go through traceability requirements and techniques useful during quality deviation investigations & potential FDA recalls. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/FDA-Recalls-and-Traceability-Requirements-2018-Trends-and-Common-Issues-505974/JULY-2018-ES-TRAININGREGISTRY
  • 12 Request Info

    FDA 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. Under 21 CFR 3.2 (e), a combination product is defined to include: A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
  • 13 Request Info

    FDA Regulation of Dietary Supplements

    Overview: 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). Why Should you Attend: To gain a fundamental understanding of FDA’s regulation of Dietary Supplements.
  • 14 Request Info

    FDA Regulations for Environmental Monitoring(EM) Program

    Overview: Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring (Pre-qualification through post-qualification EM) and what each type stands for. List the basic content of a well-designed, effective and compliant EM Program. Explain the relationship between an EM Excursion Program and CAPA.
  • 15 Request Info

    FDA Regulations for instrument Qualification and Validation Processes

    Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Why Should You Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility?
  • 16 Request Info

    Food - Current and Future Safety Regulations - 2017

    Overview: Importers of food products intended for introduction and consumption in the United States through international commerce are responsible for ensuring that the products are safe, sanitary, wholesome, and labeled according to U.S. requirements. Areas Covered in the Session: Understand "Prior Notice" requirements Foreign Supplier Verification Program (FSVP) Prepare for the Foreign Facility Inspection Program Learn what is in the “Investigations Operation Manual (IOM) What can happen to your product when seized Learn what other countries require for food import
  • 17 Request Info

    Food Business!! - Business Continuity & Disaster Recovery

    Overview: This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety. Why should you Attend: Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.
  • 18 Request Info

    Food Microbiology Methods in Validation

    Overview: The Webinar will discuss the practical distinction between and method validation and method verification and the requirements of each analytical approach to comply with ISO/IEC Standard 17025:2005 for a microbiology laboratory accreditation. Areas Covered in the Session: The difference between method validation and verification The performance characteristics for method validation Performance requirements for method verification How to implement a verification protocol that defines a method’s fitness-for purpose Who Will Benefit: Quality Assurance Managers Laboratory Technicians Laboratory Managers Regulatory Compliance Officers Consultants New employees in your food safety and quality laboratories
  • 19 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.
  • 20 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.