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Courses

  • 1 Request Info

    Webinar on Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot

    This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
  • 2 Request Info

    Webinar on FDA Regulations for Analytical Instrument Qualification and Validation Processes

    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. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.
  • 3 Request Info

    Webinar on October 2016 Clinical Trials Program

    Overview: The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes. Who Will Benefit: R&D and Regulatory Staff Management of R&D Regulatory Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/2aWhBD3 Twitter Follow us – https://twitter.com/compliance4all Facebook Like us – https://www.facebook.com/Compliance4all
  • 4 Request Info

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

    Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, personnel training and certification, inspection and data collection, maintenance and reporting that provides evidence of compliance. 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.
  • 5 Request Info

    The FDA Inspection: Preparation, Management, and Follow - up

    Overview: 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.. Why should you Attend: The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
  • 6 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
  • 7 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
  • 8 Request Info

    Webinar On New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

    If you are a shipper, carrier or receiver of foods not completely enclosed by a container or frozen, you have less than one year to establish a sound compliance system to fulfill the US FDA Law for the Sanitary and Temperature Controlled Transportation of Human and Animal Foods. The session will cover each section of the new sanitary food transportation law you need to protect consumers and your company.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/NEW-FDA-FSMA-RULES-SANITARY-TRANSPORTATION-501510/JUNE-2016-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar On Gluten - Free Labelling with a Special Focus on Fermented, Hydrolyzed or Distilled Foods: How to Prove & Display It Correctly

    Attend this webinar to avoid the pitfalls commonly associated with incorrect gluten-free claims. This webinar session will include an overview of the scientifically valid methods available for conducting gluten testing to ensure that the foods labelled gluten-free do not contain 20 ppm or more gluten.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/GLUTEN-FREE-HYDROLYZED-DISTILLED-FOODS-501470/JUNE-2016-ES-TRAININGREGISTRY
  • 10 Request Info

    Webinar On Labeling of genetically modified organisms (GMO's) in the USA

    Attend this webinar to learn an overview of the status of GMO's in the U.S., how they are regulated by the FDA, FDA's Biotechnology Policy and Biotechnology Consultation program and GMO labeling around the world. The session will refer to all FDA regulations and policies regarding GMOs as well as proposed federal, state and consumer GMO labeling initiatives.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/LABELING-GMOs-USA-501498/JUNE-2016-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar On Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps)

    This webinar will review and provide a practical approach to investigating and reporting complaints of adverse reactions related to HCT/Ps. The FDA has implemented a risk-based approach to the regulation under 21 CFR Part 1271 for HCT/Ps to prevent the introduction, transmission and spread of communicable disease.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/INVESTIGATING-REPORTING-CELLS-TISSUES-HCT-PS-501482/JULY-2016-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar On Process Validation - Current Industry Practices and FDA Guidance Document Review

    Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.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/PROCESS-VALIDATION-FDA-GUIDANCE-501491/JULY-2016-ES-TRAININGREGISTRY
  • 13 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
  • 14 Request Info

    Webinar On How to Conduct a Human Factor Analysis of Instructional Documents, Particularly Master Batch Records (MBR) and Standard Operating Procedure

    This Webinar will cover how to conduct a human factors analysis of instructional documents, which is a critical task to perform for existing documents. The concepts from this session can be incorporated into the creation of new instructional documents also.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/HUMAN-FACTOR-ANALYSIS-PARTICULARLY-MBR-SOP-501574/JULY-2016-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar On Health Canada's Regulations on Natural Health Products vs. FDA's Dietary Supplement Regulations

    This event will offer an overview of what Health Canada considers to be a Natural Health product and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.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/HEALTH-CANADAs-NATURAL-PRODUCTS-FDA-REGULATIONS-501507/JULY-2016-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar On Good Manufacturing Practice for Nutraceuticals

    Gain a complete understanding of FDA requirements for manufacturing of nutraceuticals by participating in this dietary supplements quality compliance training. The webinar will also review the FDA regulatory requirements for commercialization of dietary supplements.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/GOOD-MANUFACTURING-NUTRACEUTICALS-501582/AUGUST-2016-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar On FDA's Updated 'Nutrition Facts' Label: Understanding the changes to Nutrition Facts Labels and Serving Sizes including FSIS- USDA Proposal

    Virtually all labels on packaged food sold in the U.S. will need to be redesigned and substantively modified following a recent update to the information required in the 'Nutrition Facts' box. Importers and domestic producers will have between two and three years to comply with the new rules. This webinar will examine the key requirements as well as timelines and strategies for compliance. This training will provide a comprehensive overview of the sweeping new changes and the impacts on the food and beverage industry.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/FDA-UPDATED-NUTRITION-FACTS-LABEL-502322/MARCH-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On Trial Master File (TMF): FDA Expectations from Sponsors and Sites

    This webinar will help participants learn what is required of a Trial Master File for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor. Also, Attendees will learn which documents are essential, and which ones are not necessary in the event of an FDA audit.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/TRIAL-MASTER-FILE-FDA-EXPECTATIONS-SPONSORS-SITES-501613/AUGUST-2016-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On How to prepare for and Host FDA Inspection and Avoid 483's

    In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483's.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/HOST-FDA-INSPECTION-AVOID-483s-501677/SEPTEMBER-2016-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On FDA's Pet Food Labeling Guidelines

    This webinar will discuss the legal requirements for labeling pet or animal food. It will cover aspects of labeling such as the product name, the guaranteed analysis, the nutritional adequacy statement, feeding directions and calorie statements.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/FDAs-PET-FOOD-LABELING-501705/SEPTEMBER-2016-ES-TRAININGREGISTRY