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  • 1 Request Info

    HIPAA and the Practice Manager

    This HIPAA training will be addressing how medical practice 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 2016. There are an enormous amount of issues and risks for covered entities these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.
  • 2 Request Info

    Qualification of Clean Compressed Air Systems for cGMP Manufacturing

    In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems. Each of these applications requires a different level of air quality and a different combination of air treatment to meet the needed quality. Because the uses of compressed air within the industry vary so greatly, there is no set standard in place that every process must adhere to. While the FDA may not have issued a directive for compressed air quality in the pharmaceutical industry, there is still a resource available to help select appropriate air treatment components for a compressed air system. A typical pharmaceutical plant might have a compressed air specification of ISO Quality Class 1.2.1—Class 1 for Solids and Dust, Class 2 for Humidity and Liquid Water, and Class 1 for Oil.
  • 3 Request Info

    Webinar On Preparing for OSHA Voluntary Protection Program (VPP) Requirements: Brick by Brick

    Take a closer look at the OSHA VPP certification and how your organization can achieve this affirmation at being top in health and safety management.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 4 Request Info

    Webinar On Medical Device Recalls: a Preventive Strategy

    The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement - control throughout the product's life cycle.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 5 Request Info

    Webinar On Auditing for EMTALA Compliance

    This webinar is designed to walk attendees through a process for auditing your organization's compliance with The Emergency Medical Treatment And Labor Act (EMTALA). More specifically, it will provide an overview of EMTALA, discuss key compliance challenges facing organizations that must comply, and discuss a step-by-step approach for routine and periodic auditing.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 6 Request Info

    Webinar On Bullying Versus Harassment: The Importance of Knowing the Difference and the Legal Significance for Employers

    You know harassment is illegal; did you know there are anti-bullying laws in several states? While harassment is about protected characteristics, what exactly is bullying? How do you differentiate the two when an employee files a grievance? What other differences (and similarities) do harassment and bullying share? These are a few questions that are likely to run through your head if you are concerned about bullying in your own workplace. This webinar will provide answers to these questions, and even more importantly, provide tools to put an end to both harassment and bullying.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 7 Request Info

    Root Cause Analysis to Meet FDA Expectations - 2017

    Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Why should you Attend: A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.
  • 8 Request Info

    Medical Device Employee Training - 2017

    Overview: This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. Why should you Attend: This presentation will provide information and tips on best practices for assuring your employees are properly trained and you can demonstrate it. Improperly or inadequately trained employees lead to both product and process nonconformities.
  • 9 Request Info

    FDA Scrutiny of Promotion and Advertising - 2017

    Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. Why should you Attend: That is expensive and leaves you with a cloud over your name at the FDA. That is never a good thing. You must know what you are doing with DTC advertising, not just hope you do. You will probably earn a Warning Letter by "Winging it."
  • 10 Request Info

    How FDA Trains its Investigators to Review CAPA - 2017

    Overview: In this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
  • 11 Request Info

    Good Deviation Practice - CAPA Process - 2017

    Overview: This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. Why you should attend: The attendee will learn the best practices for the deviation process and the important points from a regulatory standpoint.
  • 12 Request Info

    How to Meet FDA QSR and ISO 13485 Requirements - 2017

    Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
  • 13 Request Info

    Customs-Trade Partnership Against Terrorism (C-TPAT) Supply Chain Security and Compliance for Regulated Industries

    The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism. The program was launched in November 2001, with seven large U.S. companies as the initial participants. By the end of 2014, more than 10,000 members joined the effort. More than 4300 importers in the program account for more than half of the value of all merchandise imported into the U.S. C-TPAT certification can be attained by companies who seek to be considered low risk, enabling their cargo to be processed in an expedited manner with fewer Customs examinations. The certification involves a documented process for determining and mitigating risk throughout a company’s international supply chain. The program is voluntary, but affords those participating in it a huge advantage in terms of international trade.
  • 14 Request Info

    Effective Environmental Monitoring Program: Best Practices in Bio/Pharmaceutical Production

    Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
  • 15 Request Info

    Risk Management, Professional Codes of Ethics, and Ethical Practice for Mental Health Professionals: A Comprehensive Guide to Navigating Ethics and La

    Nowhere but in mental health are there more diverse clinicians providing the same or similar services of counselling and therapy. Various codes of ethics and state laws intersect to govern each mental health care practitioner. Mental health practitioners are faced with a variety of high risk management process and legal situations. These events can expose clinicians to liability, lawsuits, and complaints to state licensing boards. This webinar surveys ethics and law for mental health practitioners. Learn about ethical practices, risk management, and professional codes of ethics. Mental health professionals are faced with a variety of life or death, high risk, legal situations. These events can expose clinicians to liability, lawsuits, and complaints to state licensing boards. For example, dual relationships and standard of care are two of the most common issues associated with the sanctioning of mental health practitioners.
  • 16 Request Info

    What Employers Can Implement to Minimize the Risk of Workplace Violence

    Workplace Violence in your workplace; the consequences are many, unpredictable, and can be severe. Injury or death of employees, customers, and/or visitors from workplace violence, resulting in lawsuits, property damage, increased insurance premiums, OSHA enforcement actions, increases employee turnover and reduced community trust.
  • 17 Request Info

    Webinar On A New Law for Hospitals; Discrimination; Interpreter and More: Complying with Section 1557: OCR and CMS Hospital CoPs

    This webinar will discuss a law that applies to hospitals and other healthcare providers. It addresses a civil rights law for healthcare providers and others and addresses nondiscrimination, required signs and notices, interpreters, and more under Section 1557 of the Affordable Care Act. It forbids discrimination based on sex, race, color, national origin, age, and disability. It builds on long standing and familiar Federal civil rights laws.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 18 Request Info

    Webinar On Structuring and Auditing Physician Employment Agreements: Key Legal Considerations

    In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting employment agreements 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.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 19 Request Info

    Webinar On FDA to Redefine 'Healthy Claim' for Food Labelling

    In order to make a 'Healthy' claim for Food Labeling and promotion, it's important to understand how FDA defines and will likely redefine the 'Healthy' claim. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 20 Request Info

    Webinar On Steps to HIPAA Compliance and Ransomware Prevention

    This webinar will explain what the highest risk factors for being sued for wrongful disclosures of PHI are, and the manner in which patients are now using state laws to sue for wrongful disclosures. He will also delve into specific information about multiple incidents, which will help practices and businesses understand what they did wrong that led to a HIPAA risk of ransomware.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link