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  • 1 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
  • 2 Request Info

    Adapting Hospital Employed and Private Practice Compensation Models for Clinical Integration

    The challenges faced by both hospitals and private groups are real, with different approaches to address each. However, in the midst of the challenges are incredibly opportunities to further link the method by which physicians are compensation more solidly into the mission of the respective organization. This presentation will highlight the key challenges and then provide practice insights into how to adapt both hospital employed and private practice compensation models to the new realities of medicine today.
  • 3 Request Info

    Applied Statistics, with Emphasis on Risk Management 2017- Before 30 April 50% Discount for its All Seminars

    The 2-day seminar explains how to apply statistics to manage risk 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. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: 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, from a risk management perspective Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900928SEMINAR?trainingregistry_SEO
  • 4 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
  • 5 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.
  • 6 Request Info

    Celebrating Ourselves: Beating Burnout

    Who cares for the care provider? Both paid and non-paid persons who offer their compassion, skills and resources to those in need are often at risk for burnout, compassion fatigue or vicarious traumatization, creating costly health and emotional challenges and also gaps in expertise and caring. Care providers must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When caring persons care for themselves they provide better care for others. Seminar participants will be able to: Understand dynamics of providing care Articulate how each person experiences stress uniquely Identify symptoms of compassion fatigue Utilize practical, proven solutions and exercises for stress reduction Set healthy goals and create a future response plan for stress.
  • 7 Request Info

    Complaints, Adverse Event Reporting, and Recalls 2017

    Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
  • 8 Request Info

    Conference about Writing, Negotiating, and Monitoring and Enforcing The Quality Agreement

    Outsourcing and contracting is continuing to increase in the pharmaceutical industry. Regulations have been in place for some time specifying requirements that ensure that appropriate controls are in place. This webinar will discuss the history of the regulations with emphasis on changes particularly specific to the Good Manufacturing Practices A short overview of the GMP’s quality systems will provide an overall picture of how contracting fits into the pharmaceutical Manufacturing and marketing.
  • 9 Request Info

    Developing Technical Training in the Life Sciences 2017- Before 30 April 50% Discount for its All Seminars

    Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers. The first day of this seminar will concentrate on providing foundational knowledge concerning training and development within the Life Sciences. Four 90 minute sessions will be presented on this first day that will guide the participant from a discussion of the role and function of the technical training function to the actual creation of the training organization. Important to this first day, are discussions of performance-based training, the fundamentals of training (jobs, duties, tasks Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900920SEMINAR?trainingregistry-SEO
  • 10 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
  • 11 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
  • 12 Request Info

    Electronic Health Records Software License Agreements 2017

    For physician practices just setting foot into the EHR arena, and for those practices transitioning to a new EHR software package, the fundamental document controlling their experience will be the EHR license agreement. The license agreement will or should determine issues such as how whether and how often the vendor may make online portions of the software unavailable for maintenance or other issues. how many people may use the software and on how many machines the software may be installed (if it has an offline component). what kind of technical support will be provided by the vendor. whether and under what conditions the vendor will use data entered by the practice for its own purposes. how the agreement may be terminated. and, what happens to the practice's data upon termination. Although physician practices may be keen to hasten to implementation of the software, it is crucial that they understand exactly what they are signing. This presentation examines common issues and clauses
  • 13 Request Info

    Enhancing Employee Engagement: Beating Burnout

    Persons who are responsible for the wellness of other persons and systems, such as care providers, managers, customer service staff and administrative professionals, often face stress and burnout resulting in absenteeism, turnover, increased errors and even mortality. This can be very harmful to organizational productivity and credibility, creating costly gaps in care and services. But who cares for the care providers and other employees? Providers and professionals working in education, healthcare, sales and hospitality must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When employees care for themselves first they then provide better care and services to others.
  • 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

    FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900944SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 16 Request Info

    FDA FSMA Rules & Planning Valid Preventive Food Safety Controls 2017

    Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: Understand US FDA final rules for the Preventive Controls for Human and Animal Foods Define and review your current system to identify gaps in your preventive controls planning. Be able to develop and implement a valid preventive control company food safety plan to close any gaps Write and implement appropriate procedures. Know your requirements for control over your supply chain Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901120SEMINAR?trainingregistry-September-2017-SEO
  • 17 Request Info

    FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials 2017- Before 30 April 50% Discount for its All Seminars

    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. Why should you attend: To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?trainingregistry-SEO
  • 18 Request Info

    FDA, GMP Requirements for Exploratory Clinical Studies 2017

    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. Why should you attend: To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.
  • 19 Request Info

    Final Rule on Section 1557 of the ACA 2017

    Section 1557 of the Affordable Care Act provides that current non-discrimination laws, such as the Civil Rights Act of 1964, will now apply to individuals and entities participating in any (1) healthcare program or activity that is paid for in part or administered by the Department of Health and Human Services ("HHS") and (2) federally facilitated and state-based health insurance marketplaces (collectively "Covered Entities"). Section 1557 prohibits discrimination on the basis of sex and requires treatment of individuals consistent with their gender identity in federally funded healthcare programs. The law also reaffirms the previous prohibitions on discrimination based on race, color, national origin, disability and age within federally funded healthcare programs. Additionally, Section 1557 extends these nondiscrimination protections to individuals who purchase health insurance through the health insurance marketplaces.
  • 20 Request Info

    Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements 2017- Before 30 April 50% Discount for its All Seminars

    Defining the basic requirements of Good Clinical Practices Clinical Study Protocol Elements and Device Accountability Role of Institutional Review Board (IRB) and Informed Consent Principles of Ethics and Quality Control Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials And Much More... Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900976SEMINAR?trainingregistry_SEO