Food & Beverage - Compliance

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 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/PROTOCOL-DEVIATIONS-502254/JULY-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/STOP-STRUGGLING-LARGE-WORD-DOCUMENTS-509142/JULY-2017-ES-TRAININGREGISTRY

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

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 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/FOOD-INSPECTIONS-RECALLS-CRIMINAL-LIABILITY-505438/JULY-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/PRESCRIPTION-GMPs-FDA-FORM-483-506801/JUNE-2017-ES-TRAININGREGISTRY

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

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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/COMPLAINTS-SERVICING-FDA-REPORTING-507863/JUNE-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/USA-CANADA-FOOD-MARKETING-CLAIMS-503642/JUNE-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/IMPROVING-PROCESS-STABILITY-CAPABILITY-508219/JUNE-2017-ES-TRAININGREGISTRY

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

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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FDA-REGISTRATION-MEDICAL-DEVICE-IVD-PRODUCTS-508277/JUNE-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CAPA-PROGRAM-CAPA-DATA-505212/MAY-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FDAs-EXPEDITED-DEVELOPMENT-505309/MAY-2017-ES-TRAININGREGISTRY

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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ISO-19011-2011-INTERNAL-AUDITS-505127/MAY-2017-ES-TRAININGREGISTRY

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

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

This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include death, injury and mal-function reporting requirements, record keeping requirements, report timing, clarification of the term ‘becoming aware’ and clarification of reporting using electronic form 3500A.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-MDR-REGULATION-506828/MAY-2017-ES-TRAININGREGISTRY

This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case 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/TEST-METHOD-MEDICAL-DEVICE-508490/MAY-2017-ES-TRAININGREGISTRY

Failure Mode and Effects Analysis (FMEA) is a systematic method for preventing failure through the discovery and mitigation of potential failure modes and their cause mechanisms. Actions are developed in a team environment and address each high: severity, occurrence or detection ranking indicated by the analysis. Completed FMEA actions result in improved product performance, reduced warranty and increased product quality.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/FMEA-RISK-ANALYSIS-MANAGEMENT-508377/APRIL-2017-ES-TRAININGREGISTRY

In-vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery with the advent of personalized medicine. These key products are a distinct class of medical devices regulated in the US by the Food and Drug Administration (FDA).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/REGULATORY-CHALLENGES-VITRO-DIAGNOSTIC-US-508213/APRIL-2017-ES-TRAININGREGISTRY