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:
We can no longer stand by and let toxic people erode patient safety, our self-esteem, and the bottom line! This webinar will help you take immediate action! This problem is so severe that Dr. Kusy's research discovered:
Only 1-6% of targets of incivility ever filed complaint
94% of leaders reported working with toxic people
92% rated the severity from 7 to 10 on a 10-point scale
45% said the uncivil person lashed out 2-3 times per week
51% of victims said they would likely leave as a result
You've made your decision about whom to hire.You've gotten them excited about their new job. You're excited about what they can bring to your team. Now what?If you're like most good organizations, you're 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. While this is a good thing, there is great variability in the focus, depth and length of these programs. The most superficial tend to provide surface-level "meet and greets" and focus on initial paperwork and process knowledge. Others go deeper, focusing on helping leaders learn to navigate the organization's culture and understand the informal organization and key players. What does yours do? And do you even have an onboarding program?
In a 60-minute review Michael will cover the history of this tax law benefit and how it has changed. He will illustrate the new Third-Party-Administrator (TPA) methodology for 2019 and beyond to benefit Employers and Employees. This can be done by adding this "turn-key outsourced" solution to your payroll further enhancing your benefits package.
The TPA (creator) of this plan is the ONLY group to receive a Private Letter Ruling from the IRS outlining their plan and how it is the only IRS compliant plan. The IRS came out with a Revenue Ruling (RR-2012-25) on Sept 14, 2012. Now this is the Law of the Land.
In the IRS Annual Guidance Sheet, the Plan and the Revenue Ruling are shown as the only recognized compliant plan structures.
This webinar will cover the value that mentoring can have on your organization's career development efforts. In this webinar, you will learn about the business case for implementing a mentorship program within your organization and provide you with tools and tips that successful mentorship initiatives should exemplify.
Why is proper onboarding so important? Your organization, and the applicants who want you to hire them, invest a great deal of time and resources in the hiring process. During the selection stage, the hiring manager will make the decision to extend an offer of employment with the assumption that the applicant will fit in and be an effective performer who is satisfied in the position and committed to your organization. The applicant accepts a job based on the same assumption.It follows, then, that onboarding is an important subsequent step in solidifying those decisions. It increases the likelihood of achieving the organization's expected outcomes, i.e.,effective job performance, job satisfaction, and commitment to your organization.
HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive.
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
The attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.
We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations
I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK!
In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
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. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.
Why should you Attend:
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts.
Why should you Attend:
These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used.
After this webinar, you will be able to evaluate which type of NIR would be best for your application
This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.
Why should you Attend:
This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals.
Why should you Attend:
Understand the definition and scope of human factors
Recognize the benefits of user centred design
Identify opportunities where HF may improve current processes and designs
Discuss the regulatory environment in several jurisdictions
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Trolling for off-label information in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole for firms even though it may seem innocent in your eyes.
For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperless system. Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.
OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work.
As regulators are focusing their inspection on data integrity, it is important that managers, supervisors and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance.
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.
Why should you Attend: Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle.
Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification within companies around the globe.
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics..
Why should you Attend: The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
Project management is the art and science of getting results by following a roadmap laid down to turn customers desires into concrete products and services by following established procedures in a defined sequence. The Project Management Institute brought active practitioners together to produce the Project Management Body of Knowledge, PMBOK, which is used around the world on all sorts of projects of varying sizes, with or without software support tools.
PMBOK definition: A project is a temporary endeavor undertaken to create a unique product or service. It is temporary because every project has a definite beginning and a definite end. It is Unique because the product or service delivered is different from others. Organizations use projects to achieve their strategic needs, which cannot be attained through normal operational means.
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
Although FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work environment.
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.
Emotional Intelligence is a set of emotional and social skills that establish how well we perceive and express ourselves, develop and maintain social relationships, cope with challenges and engage in life in an effective and meaningful way. Since some of the smartest people I know lack EI (or its measurement on tests EQ) I am sharing several of my observations and experiences with them. One can be brilliant and successful professionally while at the same time struggling to be socially accepted.
This course explores several aspects of EI/EQ and offers enough descriptions to enable the listener to self-identify and decide which of the elements needs self-improvement. It is also a useful tool for management in its quest to be as useful as possible to the people who report to them. We explore the different aspects of EQ and how different tests describe and measure them.
Human Resource Departments have traditionally been concerned with the processing of transactions and administrative functions - often with little or no objective data to provide them feedback on:
The effectiveness of their HR processes
Or the contribution that these processes are making to the organization's business strategy
However, many senior corporate executives are no longer satisfied with this scenario - they want HR to prove its value and Effectiveness through objective data
Human Resources metrics allow HR professionals to:
Be seen as business partners who are customer focused, strategic and change oriented
Make greater contributions to their business' strategic and operational plans
Speak the 'language of business'
Gauge whether they are satisfying the needs of their internal customers
Make continuous, meaningful improvements to HR processes
Show that they are not afraid of measuring their contribution
Avoid being outsourced
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
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