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  • 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 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
  • 4 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
  • 5 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
  • 6 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
  • 7 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
  • 8 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
  • 9 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
  • 10 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.
  • 11 Request Info

    Webinar On Incident to Billing Services

    Overview: Incident-to coding for your non-physician practitioners (NPPs) services in conjunction with a supervising physician continues to generate confusion- and 2018 will be no exception. So, it's no surprise that these claims generate higher than average denials, and lead to hefty penalties for physician practices ranging from $163K to $1.5 million - but they don't have to. Obviously, being paid 100% vs. 85% for your NPPs services is the goal. However, correctly maneuvering through complex incident-to guidelines so you can avoid audits and fines is anything but easy. That's where expert coder, Rhonda Granja, B.S., CMC, CMOM, CMA, CPC, comes in. Rhonda has put together a 60-minute training session to help you cut through the confusion of these difficult coding situations. Even if you don't see Medicare patients, you should still take note. Private carriers usually end up following suit with CMS at some point.
  • 12 Request Info

    Health Care Leasing 101: Learning the Basics to Stay Out of Trouble

    Overview: In this session Mr. Wolfe will provide an overview of the regulations that impact health care leases. He will also discuss best practices for negotiating and drafting leases on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: As health care organizations develop leasing arrangements with referring physicians, it's critical that they understand the key business, legal and regulatory considerations and trends that Mr. Wolfe will discuss in this webinar. For example, a new exception for timeshare arrangements recently went into effect under the Stark Law.Any health care organizations looking to enter into a new timeshare leasing arrangement should understand the requirements of this new timeshare exception.
  • 13 Request Info

    The Role of the HIPAA Security Official

    Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your organization needs to understand the role of the HIPAA Security Official, the requirements, and make sure the current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive course.
  • 14 Request Info

    Evolution of the Quality Management System - How to go from Surviving to Thriving

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
  • 15 Request Info

    ISO 14971 Risk Management Training-IEC 62304 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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901456SEMINAR?trainingregistry-March-2018-SEO
  • 16 Request Info

    IT Infrastructure Qualification Plan | Information Technology 2018

    GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance. Effective IT Infrastructure Qualification on the other hand, confers the following benefits. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901384SEMINAR?trainingregistry-March-2018-SEO
  • 17 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901525SEMINAR?trainingregistry-March-2018-SEO
  • 18 Request Info

    Regulatory Requirements Cleaning Validation | FDA Guidelines 2018

    This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901285SEMINAR?trainingregistry-March-2018-SEO
  • 19 Request Info

    Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901549SEMINAR?trainingregistry-March-2018-SEO
  • 20 Request Info

    HIPAA 2018 - Understanding Compliance Program Requirements

    Being in compliance with HIPAA in 2018 involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a breach investigation you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901513SEMINAR?trainingregistry-February-2018-SEO