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:
You have made your decision about whom to hire.You have gotten them excited about their new job.You are excited about what they can bring to your team.Now what? If you are like most good organizations, you are doing something more. The Aberdeen Group reported that 70 percent of all organizations currently deploy some sort of onboarding program with leaders entering new roles.
A common workplace discussion often centers around diversity and inclusion and why it should be celebrated. This training program will discuss creating a strategic plan for diversity and inclusion. It will detail building an audit plan and auditing your HR department in order to determine opportunities for improvement.
Richard Mills delivers in-depth insights on incentivizing individuals, teams and entire organizations with plans that reward positive results and acknowledges mutual success.
Territorial concerns and isolationist actions can be avoided with the proper balance of targets, metrics and milestones. When goals are set for a single sector of the organization and they do not match the goals of another sector, then offsets must be applied to compensate for the actual control that each group has to achieve their respective goals.
Meetings dominate business life today. According to the National Statistics Council, 37 percent of employee time is spent in meetings. Other data indicate there are 11 million business meetings each and every day.
Too many managers do not have the promotable trait called Executive Presence. There are numerous definitions - some focus simply on the communication skills others focus on skills that are too tactical. Leaders need to project the Executive Presence to motivate and challenge their direct reports. Learn the key skills for Executive Presence - that reflect your readiness to be promoted.
VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite).VBA is used to automate tasks that would otherwise have to be performed manually by pressing keys and selecting items with the mouse-and if that sounds like a macro-well it is.
Although Excel has a macro recorder, there's a limit to what it can do. So where the macro recorder's functionality ends, VBA takes over.
This course will show how psychological factors enter into the engineering profession. Many aspects of the engineering profession are nontechnical such as balancing "green" practices with an effective cost structure, engineering ethics, how detail oriented should an engineer be, employee mental fitness for work, manager's leadership style, and communication between engineers. There will be at least one brief exercise that students will conduct on their own with guidance from the Instructor.
This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.
This program covers a general overview of accounting and financial information and how to interpret reports so that you can make the best decisions in your role as a manager in your organization.
Why should you Attend: No matter the title you hold or how brilliant your idea is, it usually comes down to one thing the bottom line dollars and cents. Whether you're currently in apposition of organizational responsibility, or desire to advance your career, sooner or later you'll be called upon to establish financial policy in your area and be expected to evaluate and explain the results.
Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. The key is how to be legally compliant. Understand the process in how to get the proper licensure called DME PAN # and know the Federal & State Guidelines.
This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing compliance risk.
Transition between Directive 2001/20/EC and Regulation EU No 536/2014
Until the Clinical Trials Regulation EU No will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC. This Directive will be repealed on the day of entry into application of the Clinical Trial Regulation.
This course will cover both the telecommunication and technology industries and pinpoint how company operations can be improved. Recommendations on trend and ratio analysis will also be presented as applicable to diversified industries. In addition, the attendee will evaluate sales trends and develop ways to increase sales. Financial statements will be deconstructed and key drivers of organic and inorganic growth will be identified.
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given.
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: This course explains treacherous Ransomware threats attacking the Healthcare Industry and how to prevent, prepare for, respond to and recover from a Ransomware attack. It covers HIPAA Rules that apply to Ransomware, compliance with the HIPAA Rules and how to conduct a HIPAA Breach Risk Assessment to prove a Ransomware attack did not result in a Breach of Unsecured Protected Health Information (PHI) - a violation of the HIPAA Privacy Rule.
Why should you Attend:
Ransomware including new, more treacherous varieties used by cyber-criminals to attack the Healthcare Industry
HIPAA Rules that apply to Ransomware attacks
"Social Engineering" tricks criminals use to sneak Ransomware into Electronic Information Systems
What to do if your organization suffers a Ransomware attack
Best practices to:
Recover from Ransomware Attacks
How to do a HIPAA Breach Risk Assessment to determine if a Ransomware attack resulted in a HIPAA Breach - or not - if the assessment
This lesson will be addressing what human resources managers need to know regarding health records of their employees. We will go through "do's and don'ts"and cover many frequently asked questions I have received through my 17-year career in HIPAA compliance. Human resources managers need to get their HIPAA house in order as this law is now fully enforced across the board 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.
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 individuals 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 within the HR department as a whole
Overview: The webinar will cover how to find out if business associates have the necessary technical, physical and administrative safeguards in place to protect shared protected health information. The webinar will address when a vendor becomes a business associate and how that relationship may change the dynamics.
Understanding the Business Associate Agreement (BAA) process and making sure all ten government mandated requirements are in place will be covered. Find out about the use of Vendor Security Questionnaires and how to implement. The webinar will cover breaches caused by business associates and how to handle such an occurrence. If your healthcare organization needs to understand what your responsibilities are in managing business associates, please join us for this informative and interactive course
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