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Courses

  • 1 Request Info

    CAPA Training and Causes of Warning Letters

    Overview: A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system. Why should you Attend: A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation and effective means of assessing various elements of CAPA expectations for products produced and distributed under the FDA regulations.
  • 2 Request Info

    Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes 2017

    Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.
  • 3 Request Info

    Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR [Data Integrity]

    Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
  • 4 Request Info

    Implementation and Management of GMP Data Integrity

    Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods,laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations.
  • 5 Request Info

    Project Management for Non-Project Managers

    Overview: This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. Why should you Attend: It is not possible to present a complete treatment of project management in the span of 60-90 minutes. It is however possible to focus in on those most critical project management aspects that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
  • 6 Request Info

    Equipment Validation, Tracking, Calibration and Preventive Maintenance

    Overview: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.
  • 7 Request Info

    Webinar On Working with Data Models in Excel 2013+

    Many Excel data crunchers mourned the loss of easy access to PowerPivot as Excel 2013 was released. However, one of its most powerful features, the ability to analyze multiple related datasets, is now included in most versions of Excel as part of the data model.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/WORKING-DATA-MODELS-EXCEL-2013-501673/AUGUST-2016-ES-TRAININGREGISTRY
  • 8 Request Info

    Worhshop On Design of Experiments for Process/Product Optimization

    This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. Design of Experiments (DOE) is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance.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/Design-of-Experiments-for-Process-Product-Optimization-800009/NOVEMBER-2016-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar On SMED - Single Minute Exchange of Die (reduced changeover)

    (SMED) is a methodology that was created by Shigeo Shingo in the Toyota press room to reduce the time needed to setup and changeover the huge stamping presses. The goal is first to reduce setup times by 50% and ultimately to less than 10 minutes.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/SMED-SINGLE-MINUTE-EXCHANGE-DIE-501874/NOVEMBER-2016-ES-TRAININGREGISTRY
  • 10 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
  • 11 Request Info

    Webinar On 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

    All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.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/21-CFR-PART-820-QUALITY-SYSTEM-501907/DECEMBER-2016-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar On Device Master Record - Can DMR show the way to comply with QSR?

    Device Master Record (DMR) is the output of design controls and the source document for every medical device. An accurate, complete DMR gives the 'recipe' for making a medical device. From the smallest component or ingredient and simplest operation or step to the finished medical device including labels, labeling, primary, secondary and beyond packaging to installation, servicing and maintenance instructions, the DMR has everything including the exact format and content of a medical device's device history record (DHR/batch record).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/DEVICE-MASTER-RECORD-501904/DECEMBER-2016-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar On Stability Testing for Dietary Supplements

    The purpose is to present recommendation for supporting the voluntary shelf-life (expiration) dating claims of dietary supplements. The purpose of stability testing is to provide evidence on how the quality of formulation varies with time under the influence of a variety of environmental factors. Stability testing permits the establishment of recommended storage conditions and shelf lives.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/STABILITY-TESTING-DIETARY-SUPPLEMENTS-501914/DECEMBER-2016-ES-TRAININGREGISTRY
  • 14 Request Info

    Webinar On Train the Trainer: Key Tips for Engaging Adult Learners

    Adult learning is defined as ‘the entire range of formal, non-formal and informal learning activities which are undertaken by adults after a break since leaving initial education and training, and which results in the acquisition of new knowledge and skills’. In order for adults to acquire new knowledge and skills, we must deliver training to meet their learning needs. In this course, you will learn about the theories and methods to engage in Adult Learner.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/KEY-TIPS-ENGAGING-ADULT-LEARNERS-501938/DECEMBER-2016-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar On Understanding and Implementing USP 1058 - Analytical Instrument Qualification

    This webinar is designed to provide both a regulatory compliant and practical overview of equipment / instrument qualification, including requirements associated with instrumental system validation.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/USP-1058-ANALYTICAL-INSTRUMENT-501960/DECEMBER-2016-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar On Statistical Concepts of Process Validation

    If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This presentation provides the background you need on the statistical approach to process validation.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/STATISTICAL-CONCEPTS-PROCESS-VALIDATION-501979/DECEMBER-2016-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar On New Technologies Affecting Healthcare

    This course covers the new technologies affecting healthcare. During this discussion, we will look at how IoT, data analysis and advanced AI is enhancing the outcomes of individuals as well as driving new engagement models outside of the traditional care environment. As the shifting payment models are driving from fee-for-service to paying for quality outcomes, the new technologies offer continuous engagement with those in most need of follow on care.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-TECHNOLOGIES-AFFECTING-HEALTHCARE-501980/DECEMBER-2016-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On Good Post-Market Surveillance

    Post-Marketing Surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. The purpose of post-market surveillance is to protect individual health and public health through continued surveillance of products once they are placed on the market by reducing any risks.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-POST-MARKET-SURVEILLANCE-501998/JANUARY-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Why and How to use Design of Experiments

    Design of Experiments (DOE) is a key tool for quality management and continual improvement, as well as part of the Six Sigma body of knowledge. It allows the scientific determination, beyond a quantifiable reasonable doubt, of whether there is a difference between two or more treatments (such as a control or experiment) or treatment combinations. This in turn allows us to determine whether a proposed improvement worked and also to pinpoint the source of poor quality when a cause and effect diagram suggests multiple sources.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/DESIGN-EXPERIMENTS-501996/JANUARY-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella

    As the global distributers and manufacturers of Medical devices and pharmaceuticals expand their quality management system (QMS) to cover the pharmaceutical and medical device requirements under one umbrella, the need to understand the quality system requirements that are unique to each industry becomes very crucial.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/BLUE-PRINT-PHARMACEUTICAL-MEDICAL-DEVICE-501995/JANUARY-2017-ES-TRAININGREGISTRY