GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.
GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.
Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.
The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others.
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions.
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Recent events have highlighted sophisticated cybersecurity attacks everywhere including the White House.Corporations have been attacked at an alarming rate. What does this mean for computer systems validation?
The FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Ideally you will not receive a 483, which for the moment indicates you appear to be in substantial compliance.
The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer. You won't have the necessary information to make decisions or ensure qualified people are involved in the process. An ineffective process could result in an audit nonconformance from your Notified Body or even a Warning Letter from the FDA.
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract manufacturers will be explained. Change control forms will be provided and described in detail.
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Recent events have highlighted sophisticated cybersecurity attacks everywhere including the White House! Corporations have been attacked at an alarming rate. What does this mean for computer systems validation?
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.
This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation , but necessary for an effective calibration program, such as instrument classifications. It applies measurement uncertainty or test accuracy ratio to specific calibration procedures and the selection of standards to provide scientifically sound calibrations traceable to national references. The discussion applies the concepts discussed to specific key instruments found in the testing laboratory.
Overview: This course will cover the proper methodologies on conducting a HIPAA Risk Assessment based on the formula used by Federal auditors and via the guidelines of the NIST (National Institute of Standard for Technologies). The course will also cover the most important aspects to be aware of in terms of the Federal auditing process as well as the new risks regarding patients suing for wrongful disclosures.
Why should you Attend:
Have you done a HIPAA Risk Assessment?
Do you know a risk assessment is the first thing the Feds will ask for in an audit?
Is your risk assessment adequate?
Do you have written policies in place for every single one of the implementation specification of the HIPAA Security Rule (even ones that don't apply) - do you know this is required
I will show how to conduct a proper risk assessment point by point and how to also avoid scams in the market.
Overview: This lesson will be addressing how law firms who work with protected health information need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days as it relates to patients'ability to sue and the Federal governments audit process.
I will speak on specific experiences from over 17 years of working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit risks to your firm by simply taking proactive steps and utilizing best practices.
Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising.
The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates.
The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations.
Overview: This session will explain the HIPAA Rules for Web Sites and Social Media. The secret is - HIPAA Rules are easy to follow, step-by-step - when you know the steps. The HIPAA Rules, HHS/OCR guidance, Resolution Agreements provide a simple, easy to use blueprint using your Web Site and Social Media to engage patients and comply with HIPAA.
Why should you Attend: Patient Engagement is a cornerstone of MACRA and MIPS. Communication technology offers indispensable patient engagement tools. Secure, certified technology is available. But provider Web Sites and Social Media are, by far, the engagement tools patients choose. Provider Web Sites and Social Media are inexpensive, easy to build and almost universal today. However, Patient Engagement through Web Sites and Social Media pose serious risks of violating HIPAA Privacy and Security Rules.
This 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 2017. 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 all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers.
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. The course will include tips on how to understand FDA's thinking, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.
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.
Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.
Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.
Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that 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 healthcare practice, business, or organization needs to understand how to put a 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 two-day training course.
Japan's classification system differs from that of the United States or European Union
Medical devices are classified to Class I, II, III, or IV depending on their risk level
Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements
Strict new package insert requirements
Change to MAH Licensing rules
A new MAH License category for In Vitro Diagnostic (IVD) devices
A new registration system for manufacturers
A new QMS conformity assessment system
New formats for pre-market certification and pre-market approval applications
Expanded scope of third party certifications
Rules for software as a medical device
Rules for transferring pre-market certifications
And Much More...
161| Mission Falls Lane| Suite 216, Fremont| CA 94539 Fremont,