Education Training Courses

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.

Hospitals must file a National Practitioner Data Bank report on any physician's surrender of privileges if an investigation is underway. This has always been a Data Bank reporting requirement, intended to discourage plea bargains which allowed physicians to avoid being reported if they agreed to waive hearing rights. Under the new Guidebook, expanded descriptions of "investigation" and "surrender" stretch what is to be considered a reportable surrender of privileges. OPPE and FPPE and other peer review can be affected, as are physicians ability to make practice decisions without inadvertently tripping Data Bank reporting triggers. Medical staff bylaws and policies need to be reworked under the new Data Bank Guidebook.

Overview: We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties. Why should you Attend: Formal written contracts establish the legal relationship between the parties; they state the terms and conditions of that relationship and the rights and obligations of each party.

This one-hour training focuses on basic HIPAA Compliance training revolving mostly around Title II of HIPAA, Administrative Simplification. Participants will learn broadly about the enactment of the Healthcare Information Portability and Accountability Act and modifications and changes since the Act was established in 1996. Specific attention is paid to sensitivity around information sharing, patient privacy and securing medical records. There have been many updates to HIPAA since its original enactment, and participants will be able to document and put into their respective practices procedures and systems that guarantee up to date compliance with this important law. Numerous methods for creating and maintaining secure systems for protecting information are explored. In addition, participants will learn when and how information can be safely and securely shared with third parties, in a manner in which privacy is protected.

Overview: Attend this session to review, step-by-step, how you can comply calmly and confidently with this fundamental HIPAA requirement. Why should you Attend: The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U.S. Department of Health and Human Services (HHS) recently announced alarming results of the Phase 2 Covered Entity HIPAA Compliance Audits. 87% failed the Risk Analysis Audit and 94% failed the Risk Management Audit! Follow up investigations are underway, and penalties have not been announced yet. HIPAA enforcement, driven by Congressional and public demand is increasing dramatically. HIPAA Risk Analysis - Risk Management is OCR's highest compliance priority and is required of all Covered Entities and Business Associates. And it should be the foundation of every health care organization's HIPAA compliance program.

Overview: The local Medicare Administrative Contractors (MAC)s are responsible for adjudicating claims based on Comprehensive Error Rate Testing (CERT) reviews and educating providers on the findings and top trends identified. If a CERT reviewer determines that a MAC's payment decision was incorrect, the claim may be subject to payment adjustments, postpayment denials, or other actions. This webinar will introduce you to the CERT process and what categories of improper payment categories your organization should be monitoring. Is your organization aware of the categories of improper payments audited by CMS and CERT so you can be proactive in resolving before they are sent to the carrier? Why should you Attend: CERT contractors audit Medicare Part B by auditing you. This webinar will educate you on the CERT process and how your organization can be proactive in identifying your improper payment categories to maintain compliance.

This 3 hours webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. 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 regarding the do’s and don’ts with HIPAA -I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors. We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations.

The session will provide an overview of the Federal Civil False Claims Act (FCA) and how it works, the prohibitions of the Anti-Kickback Statute (AKS) and the physician anti-referral law (known as Stark II), and their available safe harbors. It will also show how violation of the AKS and/or Stark II can raise FCA concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants. We will start with a review of the Federal False Claims Act and discuss how it works and how it is being used to fight health care fraud. We will discuss how the various health care fraud task forces use the Federal False Claims Act and its whistleblower provisions to identify and prosecute health care fraud.