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Courses

  • 1 Request Info

    Seminar on Validation and Troubleshooting of Pharmaceutical Water Systems

    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
  • 2 Request Info

    Seminar on Death by CAPA - Does your CAPA Program need a CAPA?

    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
  • 3 Request Info

    Seminar on HIPAA 2019 | HIPAA Security Risk Assessment | What's new?

    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
  • 4 Request Info

    Seminar on Phase I GMPs | Drug Development Course

    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
  • 5 Request Info

    Seminar on Phase I GMPs

    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
  • 6 Request Info

    Tougher Import Rules for FDA Imports in 2019

    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
  • 7 Request Info

    Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC

    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
  • 8 Request Info

    Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management

    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
  • 9 Request Info

    Seminar on Biostatistics for the Non-Statistician

    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
  • 10 Request Info

    Webinar on Tricks of the Trade: MS OFFICE for EAs, PAs & Office Managers

    Join this MS OFFICE Training to learn how to take control of your inbox and calendar with MS Outlook; how to use features and functions of the spreadsheet tool. 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/Tricks-of-the-Trade-MS-OFFICE-for-EAs-PAs-Office-Managers-503190/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar On Healthcare Coding, Billing and Reimbursement: An Overview

    Overview: Many people work with various aspects of healthcare coding and billing but may not understand how providers generate their claim data, how they report the data to payors, and how payors use that information to reimburse providers. This webinar provides a high-level overview of all major aspects of healthcare coding, billing, and reimbursement. We discuss key data elements of the two major claim forms (CMS-1500 and UB04) and how that information tells the story of the patient’s encounter with the provider. We review the major coding systems including CPT, HCPCS, ICD-9, ICD-10, DRG, and APC, and examine how codes in each system are assigned and the purpose of each system. We review the typical process flow for how a provider submits a claim and gets reimbursed. We discuss the fundamentals of physician and hospital reimbursement, including a brief conversation of relative value units (RVUs) are and how they are used to reimburse providers.
  • 12 Request Info

    How Asperger Syndrome-High Functioning Autism Impact Theory of Mind and Emotional Intelligence

    This presentation will provide participants with a full understanding of the Theory of Mind and how it relates to Asperger Syndrome/High Functioning Autism. This concept can help explain why many individuals with this diagnosis act the way they do. Participants will learn of Baron-Cohen's attempt at assessing the Theory of Mind through the "Sally-Anne Test" and why this testing technique often creates a false negative allowing one to assume the skill is present when in reality it isn't. You will understand why this test doesn't provide the necessary information needed to address the core social deficits of this population. You will learn how perspective taking is a fundamental concern when treating Asperger Syndrome/High Functioning Autism. Participants will be provided with the latest research in Theory of Mind as it relates to how individuals with this diagnosis think and believe.
  • 13 Request Info

    Ten Best Strategies to Treat Worry and Generalized Anxiety Disorder

    Overview: Nearly everyone worries, over 25% of people believe they worry too much, and about 6% of people will suffer from generalized anxiety disorder (GAD). GAD is particularly important to treat as frequently leads to depression, medical problems, and more distressing anxiety disorders like panic disorder and OCD. In this webinar learn why your efforts to manage anxiety and worry have likely failed and learn the 10 best evidence-based treatment strategies to effectively manage GAD. Why should you Attend: Until the mid 90's worry was very difficult to treat and most therapists still struggle with helping clients to manage their worry, anxiety, and depression. Therapists' and individuals' pitfalls of treatment are two-fold: 1) Fighting anxiety actually fuels anxiety and 2) Failure to address the anxiety spiral such that we wait until too late into the anxiety spiral to use coping strategies.
  • 14 Request Info

    Designing Compliant Physician Compensation Models

    Overview: In this session Mr. Wolfe will discuss best practices for structuring and evaluating new compensation models. His presentation will also focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: Today health care organizations are focused on developing compensation models that position their physician enterprise for success. When health care organizations design a new compensation model, they must make sure the model complies with the Stark Law.This webinar will discuss how to perform this analysis. It will also discuss common compensation model structures in the industry. Areas Covered in the Session: Legal and Regulatory Overview (e.g., Stark, Anti-Kickback, etc.) Critical Components of Compliant Compensation Models Processes for Documenting Fair Market Value and Commercial Reasonableness Discuss Best Practices for Auditing Compensation Plan Implementation Common Compensation Models
  • 15 Request Info

    How to Best Manage the Emotional Rollercoaster of Asperger Syndrome-High Functioning Autism

    Many professionals are frequently frustrated when presented with a client who has social deficits associated with Asperger Syndrome/High Functioning Autism. These individuals often manifest a variety of deficits that are typically beyond the scope of many well-intentioned therapists. Techniques that have been successfully used for years with clients who struggle with similar issues but do not have the Asperger Syndrome/High Functioning Autism are often ineffective when dealing with this population and leave both the client and professional frustrated. Frequently these clients develop significant stress due to faulty social-pragmatic communication. It is this stress that creates the subsequent behavioral issues resulting in emotional outbursts that many professionals find extremely difficult to manage.
  • 16 Request Info

    Drafting and Negotiating Physician Employment Contracts: Key Business, Legal, and Compensation Considerations

    Overview: In this session Mr. Wolfe will provide practical guidance regarding physician employment contracts,including key regulatory requirements, key provisions and common compensation and common compensation models. Why should you Attend: Today the health care industry is seeing unprecedented levels of physician employment. This webinar will discuss key business, legal and compensation issues that should be considered when drafting and negotiating physician employment agreements. The webinar will focus on key regulatory requirements, key provisions, compensation and valuation considerations and potential pitfalls that should be avoided. Areas Covered in the Session: Provide a Legal and Regulatory Overview Describe Best Practices for Developing, Implementing and Auditing Provider Employment Arrangements Review Processes for Documenting Fair Market Value and Commercial Reasonableness Discuss Common Compensation Models for Employed Physicians
  • 17 Request Info

    Leasing Space to Physicians and Medical Groups: Knowing the Rules to Stay out of Trouble

    Many health care organizations lease space to physicians and physician groups and this trend is expected to continue. Unfortunately, these leases carry substantial compliance risk if they are not structured and implemented correctly.The regulatory requirements leases under the health care fraud and abuse laws (Stark Law, Anti-Kickback Statute) are very complex. In recent years, several health care organizations have made compliance missteps which subjected them to substantial penalties and settlements with the government. It’s critical for health care leaders to understand the rules surrounding leases with physicians and groups so they can spot and address issues to help mitigate risk. Many health care organizations have developed policies and processes that outline the structures, rental rates and documentation that are required when
  • 18 Request Info

    Audit Your Physician Contracts Now, Before it is too Late

    Overview: The webinar will focus on practical strategies and key takeaways from recent settlements and enforcement actions. Why should you Attend: Several of the recent Stark Law cases and settlements have highlighted the risks that result from flawed physician contracting. In this webinar,Mr. Wolfe will discuss why physician contracts must be in compliance with a Stark Law exception, and why compensation must be at fair market value and on terms that are commercially reasonable. He will also discuss developing best practices in the industry related to physician contracting and compensation model development.
  • 19 Request Info

    HIPAA, 42 CFR Part 2, and FERPA - Rules for Managing Student Health Information

    This session focuses on the issues of managing health information when it may that of students and may involve substance abuse treatment information. HIPAA and FERPA allow a number of disclosures without consent that SAMHSA prohibits without consent. First we will explain how HIPAA relates to information management and release and explain the processes required for various releases of information under the HIPAA and FERPA rules, including release according to individual access requests, and under consents and HIPAA authorizations. While FERPA overrides HIPAA, both HIPAA and FERPA take a back seat to the rules under 42 CFR Part 2. When substance abuse treatment information is involved, first you need to understand how to identify it. We will discuss how to make it distinguishable from "regular"health information, so that the appropriate extra protections can be provided.
  • 20 Request Info

    National Practitioner Data Bank Expanded Reporting Parameters

    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.