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Courses

  • 41 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 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/IMPROVING-PROCESS-STABILITY-CAPABILITY-508219/JUNE-2017-ES-TRAININGREGISTRY
  • 42 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
  • 43 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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FDA-REGISTRATION-MEDICAL-DEVICE-IVD-PRODUCTS-508277/JUNE-2017-ES-TRAININGREGISTRY
  • 44 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 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CAPA-PROGRAM-CAPA-DATA-505212/MAY-2017-ES-TRAININGREGISTRY
  • 45 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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/QIS-QIR-CMS-FOOD-SERVICE-HEALTHCARE-502170/MAY-2017-ES-TRAININGREGISTRY
  • 46 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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FDAs-EXPEDITED-DEVELOPMENT-505309/MAY-2017-ES-TRAININGREGISTRY
  • 47 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
  • 48 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 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/SOLVING-STATISTICAL-MYSTERIES-506995/MAY-2017-ES-TRAININGREGISTRY
  • 49 Request Info

    Webinar On Medical Device Reporting Requirements for Manufacturers Final Guidance

    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
  • 50 Request Info

    Webinar On Test Method Validation to Verify your Device Performance

    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
  • 51 Request Info

    Webinar On Regulatory Challenges Facing In-Vitro Diagnostic in U.S.

    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
  • 52 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
  • 53 Request Info

    Webinar On Understanding Corrections and CA&PA;

    This presentation explains the differences as well the QMS requirements to help you understand, implement, and maintain the effective systems.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/UNDERSTANDING-CORRECTIONS-CA-PA-509049/APRIL-2017-ES-TRAININGREGISTRY
  • 54 Request Info

    Webinar On FDA to Redefine 'Healthy Claim' for Food Labelling

    In order to make a 'Healthy' claim for Food Labeling and promotion, it's important to understand how FDA defines and will likely redefine the 'Healthy' claim. 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-HEALTHY-CLAIM-502129/APRIL-2017-ES-TRAININGREGISTRY#
  • 55 Request Info

    Webinar On How to Buy COTS Software, Audit Vendors and Validate the Software

    This presentation will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and evaluating software vendor(s). Presentation will highlight essential data and systems subject to Part 11 & Annex 11 (ERES - Electronic Records and Electronic Signatures) compliance while listing requirements for IT infrastructure, Laboratories, Manufacturing/ Operations, R&D, Regulatory and other GxP relevant areas of an FDA regulated manufacturer. 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/COTS-SOFTWARE-AUDIT-VENDORS-505707/MARCH-2017-ES-TRAININGREGISTRY
  • 56 Request Info

    Webinar On Quality Systems Inspection Technique (QSIT) and How to use it to Your Advantage

    Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, "FDA's Quality System Inspection Technique (QSIT)," is intended to facilitate manufacturer compliance with the FDA's Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.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/QUALITY-SYSTEMS-INSPECTION-TECHNIQUE-505266/MARCH-2017-ES-TRAININGREGISTRY
  • 57 Request Info

    Webinar On The new Food Concern Spectrum: Food Authenticity

    While the concerns over food fraud trend after notable events, this webinar steps up into a higher elevation approach to the issue. Food Fraud is one of five key areas of food concerns under the umbrella of food authenticity. The list of concerns includes: Food Quality, Food Safety, Food Fraud, Food Defense, and Food Security. This course will help attendees understand the specific risks for each of the five concerns and how they are different from each other.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/FOOD-AUTHENTICITY-502280/MARCH-2017-ES-TRAININGREGISTRY
  • 58 Request Info

    Webinar On Secrets for Writing Excellent SOPs (Standard Operating Procedures)

    Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.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/SECRETS-WRITING-EXCELLENT-SOPs-504929/MARCH-2017-ES-TRAININGREGISTRY
  • 59 Request Info

    Webinar On How the FDA & FTC Regulate Advertising & Promotion of Drugs & Dietary Supplements

    This webinar will cover FDA regulatory compliance requirements for all manufacturers and distributors who want to advertise and/or promote OTC drugs and dietary supplements in the U.S. The relationship between FDA and the FTC will be covered. Guidance will be provided on how to advertise OTC drugs and dietary supplements while avoiding misleading or unsubstantiated claims.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-FTC-REGULATE-ADVERTISING-509777/MARCH-2017-ES-TRAININGREGISTRY
  • 60 Request Info

    Webinar On Three Years into the Drug Supply Chain Security Act (DSCSA): Where Does Industry Stand?

    The federal Drug Supply Chain Security Act (DSCSA) established new licensing, track-and-trace and preemption requirements for prescription pharmaceutical manufacturers, distributors and dispensers in the U.S. Three years have now passed since enactment of this law, but FDA has yet to publish key implementation standards. In the meantime, industry must comply with various deadlines. Individual state agencies also continue to act to fill perceived voids, complicating efforts toward national uniformity for operations.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/DRUG-SUPPLY-CHAIN-SECURITY-ACT-DSCSA-502056/MARCH-2017-ES-TRAININGREGISTRY