Public Education

Learn the tools, methods and exercises you can use to navigate Social Dynamics to make work life more stress free and enjoyable. 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/How-to-Navigate-the-Social-Dynamics-of-Your-Organization-508486/APRIL-2019-ES-TRAININGREGISTRY

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong More: https://www.globalcompliancepanel.com/seminar/a-to-z-microbial-control-monitoring-validation-901945SEMINAR/?SEO

This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you. We'll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection. More: https://www.globalcompliancepanel.com/seminar/death-by-CAPA-Does-your-CAPA-program-need-a-CAPA-901954SEMINAR/?SEO

This two-day seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. More: https://www.globalcompliancepanel.com/seminar/HIPAA-2019-What's-new-901951SEMINAR/?SEO

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs. More: https://www.globalcompliancepanel.com/seminar/seminar-on-phase-I-GMPs-901939SEMINAR/?SEO

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs. More: https://www.globalcompliancepanel.com/seminar/seminar-on-phase-I-GMPs-901939SEMINAR/?SEO

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. More: https://www.globalcompliancepanel.com/seminar/tougher-import-rules-for-FDA-imports-in-2019-901948SEMINAR/?SEO

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations More: https://www.globalcompliancepanel.com/seminar/applied-statistics-with-emphasis-verification-901933SEMINAR/?SEO

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties More: https://www.globalcompliancepanel.com/seminar/applying-ISO14971-and-IEC62304-901942SEMINAR/?SEO

Why should you attend: Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test? More Information Click Here: https://www.globalcompliancepanel.com/seminar/biostatistics-for-the-non-statistician-901936SEMINAR/?SEO

Learn the tips and tricks of visualizing Excel Data with Smart Art presentations and charts. Register today for the webinar. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Visualizing-Excel-Data-with-Smart-Art-Presentations-and-Charts-505000/JANUARY-2019-ES-TRAININGREGISTRY

Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts. Why should you Attend: These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used. After this webinar, you will be able to evaluate which type of NIR would be best for your application

Overview: This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals. Why should you Attend: Understand the definition and scope of human factors Recognize the benefits of user centred design Identify opportunities where HF may improve current processes and designs Discuss the regulatory environment in several jurisdictions

Overview: FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole for firms even though it may seem innocent in your eyes.

This course offers practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues, Also we will discuss why supervision is so important in reducing and preventing human error, And also you will learn how to measure human error rates at your department and keep track of metrics.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

In this webinar speaker will explain How to write or record information in a compliant way (includes text, numbers, electronic signatures etc), In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Overview: Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.

This Project management training will provide you with a solid foundation for managing that first project or to simply sharpen existing project management skills, It is not just important to learn about project management - project management has its own body of knowledge, Also The webinar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.

Overview: The logistics industry is huge, worldwide and critical to our global economy. The industry consists of transportation, warehousing, logistics and technology companies that move goods (physical assets) from producers to consumers. The industry has grown rapidly in size and sophistication as supply chains became bigger and more demanding. Block chain is one of the technologies that may provide the next advancement in connectivity, speed, transparency, security, productivity and cost savings for the logistics industry.