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Courses

  • 21 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.
  • 22 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
  • 23 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.
  • 24 Request Info

    Traceability and Recall Through Food Processes by Compliance4all

    Overview: This 60 minute webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols. A variety of technologies at various price levels that are used for tracking and recall will be covered. There are quite a variety of potential applications ranging from simple case level bar code systems to more sophisticated satellite systems that include sensors for explosives, bacteria and other issues will be discussed. Test data from a number of these systems will be shown in cross country and trans-ocean applications. Farm, distribution center, blending operations, pallet level vs container and case level systems will be explored.
  • 25 Request Info

    Two Days Workshop On Quality Management Systems that Comply with ISO13485:2016

    Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Price:$1400.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/workshop/Quality-Management-Systems-that-Comply-with-ISO13485-2016-800016/NOVEMBER-2016-ES-TRAININGREGISTRY
  • 26 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.
  • 27 Request Info

    Webinar On 3 hours virtual seminar on: Healthcare Medical Software/Applications - Risks, Validation & Interoperability

    The complexity and expanding use of software outpaces what the industry understands and regulatory concerns. This creates challenges to the development of software programs, especially ones that can accommodate future designs and use. Regulations of Medical Device Data Systems (MDDS) lay out criteria for the lowest level of software regulation. Future criteria remain fluid based on changing technology and its likely evolution. In the meantime, providers and suppliers need to establish a regulatory compliant approach that can be adapted to future regulatory paradigms and initiatives.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/HEALTHCARE-MEDICAL-SOFTWARE-APPLICATIONS-507892/JUNE-2017-ES-TRAININGREGISTRY
  • 28 Request Info

    Webinar On Adverse Event Reporting - Best Practices Dietary Supplements

    Adverse Event Reports should be a major concern for dietary supplement companies as adverse events can happen at any time. Adverse Event Report issues can be overwhelming for any business, but with the right system in place, there's no need to fear. Reporting and documenting serious adverse events in a timely manner for the Food and Drug Administration (FDA) is a necessity for the dietary supplement industry.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/DIETARY-SUPPLEMENTS-501765/OCTOBER-2016-ES-TRAININGREGISTRY
  • 29 Request Info

    Webinar On An Introduction to Risks associated with Extractables, Leachables & Elemental Impurities in cGMP Manufacturing: A Project Managers Perspect

    This webinar will present a unique perspective on risks associated with extractables, leachables & elemental impurities (ELEI) in cGMP manufacturing of pharmaceutical, biologic and medical device products. The webinar will start with a definitional review of the topic and then present the current FDA perspective on impurities of these types in product. After that introduction, the instructor will present quality and compliance considerations related to ELEI.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/EXTRACTABLES-LEACHABLES-cGMP-MANUFACTURING-507103/JULY-2017-ES-TRAININGREGISTRY
  • 30 Request Info

    Webinar On Analytical Method Validation under Good Laboratory Practices (GLPs)

    This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements. It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP) with FDA compliance training.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/GLPs-ANALYTICAL-METHOD-VALIDATION-501410/JUNE-2016-ES-TRAININGREGISTRY
  • 31 Request Info

    Webinar On Application of CMS Quality Indicator Process in Healthcare Food Service

    The Centers for Medicare & Medicaid Services (CMS), in collaboration with public and private partners, is transforming how they conduct business and operations, connect providers and empower consumers and their beneficiaries.CMS enhances its partnerships in a delivery system where providers are supported in achieving better outcomes in health and health care at lower cost for the beneficiaries and communities they serve.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/CMS-QUALITY-INDICATOR-501905/DECEMBER-2016-ES-TRAININGREGISTRY
  • 32 Request Info

    Webinar On Applying Human Factors and Usability Engineering Throughout the Medical Device Development Lifecycle

    For medical device manufacturers, human factors engineering has gradually become part of the standard expectations for products on an FDA approval pathway. Though it is possible to execute successful studies that only meet the FDA's minimum standards for human factors, this strategy does not necessarily result in products that have been optimized for safety and usability.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-DEVELOPMENT-LIFECYCLE-505949/JULY-2017-ES-TRAININGREGISTRY
  • 33 Request Info

    Webinar On Audit for FDA Regulated Industry - An Essential Tool for Continuous Improvement

    This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating and reducing compliance risk.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/AUDIT-FDA-REGULATED-INDUSTRY-506266/MAY-2017-ES-TRAININGREGISTRY
  • 34 Request Info

    Webinar On Avoiding Common Mistakes in Medical Device Human Factors

    With the recent finalization of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, device developers have a clearer picture of the expectations for human factors testing on devices for which they seek clearance or approval. However, attempting to meet the FDA expectations using the guidance alone often results in limited understanding and poor execution of human factors studies.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/AVOIDING-MISTAKES-MEDICAL-DEVICE-501849/NOVEMBER-2016-ES-TRAININGREGISTRY
  • 35 Request Info

    Webinar On Benefit and Risk Factors to be considered for managing the FDA IDE (Investigational Device Exemption) Submission for Medical Devices

    Key benefit and risk factors to be considered while submitting an investigational device exemption (IDE) to FDA will be discussed in this webinar. IDE submission allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link
  • 36 Request Info

    Webinar On Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection

    This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/RESPONSE-FDA-INSPECTION-508464/APRIL-2017-ES-TRAININGREGISTRY
  • 37 Request Info

    Webinar On Biotechnology in Food Processing - How Has it Evolved to Help Us?

    This training program will focus on the advancements in biotechnology in the meat, milk, and agriculture industries. It will also weigh out the pros and cons of biotechnology advancement and examine labeling requirements for biotech foods.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/BIOTECHNOLOGY-FOOD-PROCESSING-501581/JULY-2016-ES-TRAININGREGISTRY
  • 38 Request Info

    Webinar on Building Your Company FDA FSMA Preventive Control and Food Defense Plans

    Join this webinar by expert speaker Dr. John Ryan, PCQI, to discuss plan development of the preventive control food safety plan and the food defense plan. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Building-Your-Company-FDA-FSMA-Preventive-Control-and-Food-Defense-Plans-509624/JUNE-2018-ES-TRAININGREGISTRY
  • 39 Request Info

    Webinar On Cleaning Validations Using Extraction Techniques

    Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CLEANING-VALIDATIONS-EXTRACTION-TECHNIQUES-503258/JUNE-2017-ES-TRAININGREGISTRY
  • 40 Request Info

    Webinar On Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints!Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/COMPLAINT-MANAGEMENT-502650/AUGUST-2017-ES-TRAININGREGISTRY