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  • 61 Request Info

    Webinar On Protocol Deviations: Documenting, Managing and Reporting

    Deviations have often been misunderstood, misclassified and misreported. This webinar will help you to answer questions about deviations such as: What is a deviation? What’s the best way to manage deviations? Can they be avoided? What is their importance? Does deviations impact subject safety or data integrity? How can the research team anticipate, manage, and minimize the impact of protocol deviations?Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 62 Request Info

    Webinar On Stop Struggling with Large Word Documents: Manage with Ease

    Designed to save you time, this webinar will cover features new to Word 2013 and offer tips for further automating your work with them. Need-to-know shortcuts for setup, navigation, selection and formatting will be demonstrated along with automatic report covers, auto Table of Contents, differing Headers and Footers, Bookmarks, Cross-References, and more.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 63 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 Event link
  • 64 Request Info

    Webinar On Food Inspections, Recalls and Criminal Liability

    Food Inspections, Recalls and Criminal liability address the spectrum of proactive to reactive compliance elements within the food industry. From pre to post harvest, from food manufacturing to retail/restaurant, compliance activity is both embraced and, in some cases, avoided. This webinar will cover foundational statutes of state and federal inspection activity (USDA and FDA) of food, as well as recall authority. Current trends in recalls will be explored. We will also analyze recent changes to the prosecutorial landscape of criminal liability in regards to food.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 65 Request Info

    Webinar On Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions

    In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 66 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 Event link
  • 67 Request Info

    Webinar On Complaints, Servicing and FDA Reporting

    This presentation provides a framework for understanding, managing, and reporting adverse events to the FDA. It uses plain English to describe the regulatory requirements as well as common quality tools such as flow diagrams and fault tree analysis. This approach helps participants understand and implement the essential parts of the regulations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 68 Request Info

    Webinar On USA and Canada Food Marketing Claims

    This webinar on Food Manufacturing Claims will detail the labeling requirements for foods under the Federal Food, Drug & Cosmetic Act and its amendments in addition to the CFIA and Health Canada.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 69 Request Info

    Webinar On Improving Process Stability and Capability - Tips, Traps and Guidance

    Learn the "What", "Why" and "How" of improving process capability and stability. Topics discussed include: FDA Guidance, pharma and biotech industry experience, pitfalls to avoid, sampling procedures and data quality.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 70 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
  • 71 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 Event link
  • 72 Request Info

    Webinar On FDA Registration: Medical Devices, IVD and Combination Products

    The medical device submissions process in the US is a complex process. The regulations at times can be confusing and appear to be vague or contradictory. It is imperative to understand the similarities and differences in submissions approaches when formulating a marketing strategy for your medical device. Incorrect classification decisions for medical devices for example, can be costly and extend the submissions process far beyond what it should. Formulating a proper submissions strategy begins with understanding the regulatory requirements, the avenues or approaches to submissions, the power of proper device classification, and how those submissions should be best undertaken. This webinar will explain and explore these topics.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 73 Request Info

    Webinar On Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates non-conformances and potential non-conformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Application of risk management to your CAPA program will be discussed throughout the webinar.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 74 Request Info

    Webinar On Understanding the Quality Indicator Survey Process (QIS), Quality Indicator Programs (QIP) and the processes and requirements of CMS for Fo

    Based on a 2010 survey 40 percent of the 15,000 long term care facilities failed to meet the bases of 42 CFR. This Webinar will focus on the opportunity for Food Service Operations to perform within the intended regulation, understand and interpret intent. This webinar may be used as a training tool for food service managers who want to perform higher in the (QIS), or who have failed in the past to implement CMS guidelines.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 75 Request Info

    Webinar On FDA's Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals

    FDA's Breakthrough Therapy, Accelerated Approval, Priority Review and Fast Track designations can reduce product approval timelines if pursued and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about what's best for your product development program.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 76 Request Info

    Webinar On ISO 19011:2011-Guidelines for Auditing Management Systems to Conducting Effective Internal Audits

    This webinar will utilize ISO 19011:2011, ICH Q10 and FDA guidances and explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program, an overview of various cGMP regulations and how to reinforce their quality system, along with potential efficiency enhancements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 77 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 Event link
  • 78 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 Event link Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 79 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.
  • 80 Request Info

    Webinar On Solving Statistical Mysteries - What Does the FDA Want?

    This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations.Use of statistics has been part of the FDA's guidance and regulations for many years. Use of statistical tools is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link