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:
In this webinar speaker will review the user fees themselves in more detail and discuss the performance goals established as a result. And finally, she will devote the bulk of this presentation to highlighting the program areas addressed with the passage of MDUFA IV.
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
There are many questions about the ongoing inspection and enforcement program, e.g., what inspectors are looking at, what are major findings and what are the FDA expectations about follow up.
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
The following subjects will be covered in detail:
How to compare two or more fields in a variety of layout styles
How to sort and filter results
How to perform ad-hoc grouping of information
How to use Slicers instead of filters to identify which field elements are displayed
How to drill down to see the details behind the summary
How to categorize date/time data in multiple levels
There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.
Data security is the high priority in any organization but especially in a regulated industry. Companies need to safeguard against every possible vulnerability across their entire infrastructure. In order to successfully safeguard data, data governance needs to be implemented.
The Behavioral Based Safety system (BBS) is a valued tool used in conjunction with other safety and health aids, such as, job hazard analysis, fault tree analysis, audits, and inspections. The BBS focuses on the behavior of the worker which is measurable and observable, unlike a person's attitude.
When behavior which can cause accidents and organizational loses are observed, the BBS system will give aids to the safety officer in coaching safe behavior. The final output of an effective BBS system is to create a safety culture.
Microsoft Excel has become the de facto spreadsheet application for business. But do you sometimes feel like you have rows and rows of data and it's hard to make heads or tails of it? This class will help you learn how to manage databases in Excel, and get the most out of them.
For 75-minutes, Excel expert Dennis Tom Fragale will lead you through a full array of powerful and easy-to-use database commands and methods critical to effectively working with Excel databases. In this webinar, you will learn how to improve your Excel database skills so that you can better summarize info-making better, more-informed business decisions
This course offers extensive examination of the FDA's regulations of biological products such as HCT/Ps from pre-clinical testing to post-marketing regulatory requirements. Specific ethical and regulatory considerations will be discussed for various HCT/Ps. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products.
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.
Most users are under-utilizing Excel and could be saving minutes every day and hours every week if they learn some of the many tips presented in this fast-paced webinar. In these days of tight budgets and hiring freezes, its' all the more important for you to use your existing software more efficiently. This webinar will give you the productivity boost you need as you become a more proficient Excel user.
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
In this webinar We will explain the role of Risk Management in Non-Product Validation, understanding how to avoid major mistakes when validating software to FDA standards, This webinar will review the validation planning process with emphasis on avoiding common pitfalls, The attendee should leave the presentation confident in their ability to improve the level of validation success.
Evaluation and Management codes are often vulnerable to third-party auditor scrutiny. Payers frequently use different types of analyses to identify outliers with E/M coding, such as physicians who bill higher-than-normal levels of more intensive codes. Other auditors, such as Recovery Auditors, Medicare Administrative Contractors, and Zone Program Integrity Contractors often follow the same process to use this same type of data to calculate from analytics.
Given the increased scrutiny of these codes, it's important to be confident with E/M and other coding that it is reflective of the accurate documentation during the patient encounter.
During this webinar, we will revisit E/M coding guidelines and other top office services for Behavior Health professionals. There will be sample scenarios used during the webinar to help define the reason for the patient encounter documentation requirements that meet the definition of the code.
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Perhaps if everything always executed as planned then we would not need procedures, but this is not the case in the real world. An SOP or Standard Operating Procedure is used to ensure business processes are well thought through, that each task in a process is performed the same way every time, and important data is recorded, along with errors or deviations so corrective action can be taken. Standard operating procedures used in combination with planned training and regular performance feedback lead to an effective and motivated workforce.
Attachment-based family therapy (ABFT) is a manualized, empirically informed and supported, family therapy model specifically designed to target family and individual processes associated with adolescent suicide and/or depression. ABFT emerges from interpersonal theories that suggest adolescent depression and suicide can be precipitated, exacerbated, or buffered against by the quality of interpersonal relationships in families. It is a trust-based, emotion-focused psychotherapy model that aims to repair interpersonal ruptures and rebuild an emotionally protective, secure-based parent-child relationship.
Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance.
In this webinar speaker will Discuss leadership development as a fundamental element of succession planning, A succession plan is a road map for future leadership at an organization, including direction about how internal talent will be developed, The Succession Planning and Leadership Development Toolkit is a key component of the “Our People, Our Strength” plan - the guiding strategy for shaping the County into a workplace that recruits and retains high quality employees.
In this practical and interactive program you will learn how to manage your recruiting process to attract millennial applicants over the competition, how to develop them and to retain them longer than average, Learn how to brand your organization as a preferred place Millennials want to work.
This one-day seminar will get into the fine details of what we need to do and how to do it.
We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's and don'ts with HIPAA. I want to add clarity for compliance officers.
It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.
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.
The objective of the seminar is to provide information that can be used immediately by personnel involved in production operations, and by supervisors and management in decision making. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement processes and testing within the statistical framework.
Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
Outreach training content includes hazard recognition and avoidance, workers' rights, employer responsibilities, and how to file a complaint; it emphasizes the value of safety and health to workers, including young workers.
Participants receive a participation card from the US Department of Labor.
Managers who want to increase their competitive advantage by anticipating their customers' priorities, needs and expectations
Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs' flexibility and responsiveness
Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department's value to the organization
Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!
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