Payroll Virtual Boot Camp: Wage & Hour

Knowledge of these five areas of wage and hour law is critical for payroll professionals:

• Paying exempt employees
• Calculating gross wages under the FLSA
• Deducting from an employee’s wages
• The nuts and bolts of physically paying employees, and
• Changing payroll frequencies.

A marathon, six-hour training session on April 8 from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will explain these at depth, so that payroll professionals can understand how to implement these and stay compliant with the law. This knowledge also helps them to protect their company from potential financial disasters.

Vicki M. Lambert, president and academic director of The Payroll Advisor™, will be the expert at this session. Kindly visit Globalcompliancepanel to register for this highly important learning on payroll.

Aimed at offering valuable benefits to professionals related to payroll, such as Payroll Executives/Managers/ Administrators/Professionals/Practitioners/Entry Level Personnel, Human Resources Executives/ Managers/ Administrators, Accounting Personnel, Business Owners/Executive Officers/ Operations and Departmental Managers, Lawmakers, Attorneys/ Legal Professionals, or any individual or entity that must deal with the complexities and requirements of Payroll compliance issues; this session will impart its learning agenda in the following manner:

Hour One: Paying Exempt Employees

• What is exempt-exactly?
• What are the categories of exempt employees?
• What is the salary level test-beginning in 2020?
• What is salary basis?
• When you can and when you cannot dock the pay of an exempt employee

Hour Two: Wage and Hour Compliance-Its Overtime and Much More!

• Federal minimum wage
• state minimum wage
• credits against minimum wage
• Youth minimum wage (training wage)
• Board and lodging credits
• Defining the legal work week and workday
• What is considered hours worked and how do they affect overtime
• What is regular rate of pay? Do new 2020 DOL regulations change this definition?
• How is overtime calculated under the FLSA
• Posting requirements
• Meal and rest periods
• Where do the states stand?

Hour Three: Deducting from an Employee’s Paycheck

• Taxes-which are mandatory, which are a courtesy, and which ones the employee controls
• Child support-the limits but not beyond
• Tax levies-federal and state
• Creditor garnishments-how many can you honor and how often
• Voluntary wage assignments for “payday loans”-when are they required to be honored
• Handling fringe benefits such as health insurance or group term life
• Uniforms-when the employer pays for it and when the employee furnishes it
• Meals-when they become part of the employee’s wages
• Lodging-when it is part of the employee’s wages and when is it a perk
• Shortages-the employee came up short so they have to cover that right?
• Breakage-you broke it so you have to pay for it, legal or not
• Overpayments-the employee was overpaid so you can just take the money back or can you?
• Advanced vacation pay-the employee knows the vacation hours were advanced so we can take them back when the employee quits can’t we?

Hour Four: The Nuts and Bolts of Physically Paying an Employee

• Required payroll notices to new hires
• Frequency of wage payments
• Paystub regulations
• Lag time between closing the payroll and distributing the check
• Pay date rules
• Payment methods permitted by state including cash, check, direct deposit and paycards
• Statements and payday notices
• Paying terminated employees
• Paying out accrued vacation

Hour Five: Changing Payroll Frequencies

• Understanding the need for the change
• The choices available
• Compliance issues involved
• The change’s impact on payroll
• The change’s impact on employees
• The change’s impact on systems and procedures
• Key communication factors to include at all stages of the change
• Formulating the plan to implement the change
• Testing the change before implementation
• Implementation and the outcome

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About the expert: Ms. Lambert conceived of, created the teaching and student manual, and coordinated the program for the certificate in Payroll Practice and Management that has been offered on site through the Extended Education Offices of a few universities.

With nearly 40 years of hands-on experience in all facets of payroll functions as well as over three decades as a trainer and author, Ms. Lambert has become the most sought-after and respected voice in the practice and management of payroll issues. She has conducted open market training seminars on payroll issues across the United States that have been attended by executives and professionals from some of the most prestigious firms in business today.

A pioneer in electronic and online education, Ms. Lambert produces and presents payroll related audio seminars, webinars and webcasts for clients, APA chapters and business groups throughout the country. Ms. Lambert is an adjunct faculty member at Brandman University in Southern California and is the creator of and instructor for their Practical Payroll Online program, which is approved for recertification hours by the APA.

Controlling Human Error in the Manufacturing Floor

All the technological advancements in the automation processes of many industries notwithstanding, human labor continues to be a core part of manufacturing. This means that manufacturing is highly prone to human error. This is natural, because human error is inseparable from the human presence. Wherever there is human involvement, the potential for human error accompanies it, because, as the old saying goes, to err is human. With all the meticulousness that humans are capable of, the scope for human error can never be ruled out.

Human error has serious costs for the economy, because manufacturing is a vital industry in most countries of the world. Irrespective of whether the human error is intended or not, the loss that accrues from it is unavoidable. An error in one stage of manufacturing can spill over to other areas, curtailing the entire chain. It is no exaggeration that human errors cost the global economy billions of dollars in losses and kill incalculable productivity time.

GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on March 19, at which all the aspects relating to human error in manufacturing, and the ways of minimizing it, will be explained. GlobalCompliancePanel brings Ginette Collazo, a human error and human behavior expert who has spent more than 15 years in technical training, organizational development and human reliability areas, as the expert at this webinar.

To enroll for this six-hour session, please visit Globalcompliancepanel .

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Ginette will drive home the point that although it is impossible to totally eliminate human error in manufacturing, it is possible to minimize it to the lowest level that one can bring it down to. Human error in manufacturing can start at the design stage and can go to all the areas such as procedures, training, and workplace environment, where variables are involved.

She will explain the ways by which an understanding of human psychology can help locate exactly where the error lies and correct the weaknesses in the system to the point where they can be fixed.

At this session, she will offer simple and practical tools which participants can use immediately and start reducing most human errors. This webinar will make a discussion of human error categories, near root causes and root causes for these events, as well as the current trends in human error issues in the manufacturing industry.

Participants will:

• Understand human error: factors and causes
• Understand the importance: regulatory and business
• Define the process to manage Human Error deviations
• Identify Root Causes associated to human error deviations
• Learn how to measure human error rates at your site
• Identify what to do to support human reliability.

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About the expert: Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

 

Tougher Import Rules for FDA Imports in 2020

Those who import FDA regulated products to the US need to be very meticulous in planning their activity. If they get any of these aspects wrong-registration, product compliance, record and data submission-their product can be detained.

Likewise, the requirements set out by the U.S. Customs and Border Protection (CBP) must be completely precise, failing which an importer’s item could get aborted before it enters US shores. While it is common for importers to make certain kinds of errors, most others accrue from a lack of understanding of how FDA and Customs and Border Protection (CBP) operate their joint program.

Importers should realize that any decision they take regarding the logistical aspects of importing products comes with its own set of consequences. They could end up coughing huge amounts of money, apart from the time they will have to spend in securing the release of their detained products.

This becomes all the more frequent if they do not know how to work with the FDA. Knowledge is a core factor there. For instance, being aware of the fact that they are not allowed to appeal if their entry is refused, or of the fact that they could face the prospect of attracting additional steep fines by CBP and get blocked from the U.S. market can go a long way in alleviating their problems.

It is knowledge of this kind that a webinar being organized on March 24 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is going to impart. This webinar, titled “6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020”, will have Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, as the expert.

Please enroll for this learning by visiting globalcompliancepanel .

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Most problems concerning imports to the US market arise because importing firms are not aware of the ways of preparing, conducting and reporting information in a manner that meets the FDA’s requirements. The truth is that the FDA is more than willing to help importers who meet their requirements, but is equally harsh and unforgiving on those that don’t.

So, the basis to operating an import business and profit from the US market is to comply with the FDA regulations. Importers need to grasp the FDA’s and CBP’s import program, which is what this webinar will familiarize its participants with.

Casper will cover the following areas at this session:

• FDA’s legal authority and burden of proof
• FDA registration, product information and the software PREDICT screening program
• CBP entry information and the Automated Commercial Environment (ACE) program
• Tariffs, fees, bonded warehouses, and free trade zones (FTZ)
• Special labeling requirements, e.g., bulk active pharmaceuticals, research use, investigational use, and return for repair
• FDA “holds,” “detentions” and what to do immediately
• Negotiating with FDA

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About the speaker:

Casper Uldriks, who owns the firm, Encore Insight LLC, specialized in the FDA’s medical device program as a field investigator, and served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements.

Over 32 years of having worked with the FDA, he understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

 

 

 

Project Management for Non-Project Managers

Project management is one of the skills even those whose domain of expertise it is not, are expected to know in detail. Project management is a very useful supplementary skill to have for non-project managers simply because every work in most organizations gets done as projects. When project managers or others who work on project management are unable to deliver-whatever be the reason for it-others are expected to fit into their shoes and deliver. This substitution can make the difference between the completion and noncompletion of a project.

A six-hour webinar from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will show how non-project managers can acquire knowledge of project management. This webinar, which is being organized on March 20, brings Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, as the expert.

Kindly visit globalcompliancepanel  to enroll for this valuable learning and gain insights into how to ensure that projects do not get stalled for want of availability of the right personnel.

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Charles will give an understanding of the critical tasks within each project phase that non-project managers must perform rightly if the project is to be completed on time while meeting the requirements. This learning will offer a foundation and direction for future study of the subject.

Over the course of these six hours, Charles will offer the basic tools that smoothen the implementation of a project. These tools are vital to ensuring this. He will divide this webinar into two three-hour slots, during which he will offer learning of the ways by which to manage the project from beginning till end, moving logically across these endpoints during these two sessions.

This webinar is of core importance to any member of a cross functional project team that has the potential opportunity to lead that project, engineers, marketing associates, product managers, program managers, contract managers, project managers, Research & Development Associates, managers, and directors, design engineers, and manufacturing managers.

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About the expert: Paul’s company, C. H. Paul Consulting, Inc., is a regulatory, manufacturing, training, and technical documentation consulting firm. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years, and has published numerous white papers on various regulatory and training subjects.

Apart from holding senior positions in consulting and in corporate training development, he has also worked for several years in government contracting, where he has managed the development of significant Army-wide training development contracts. His work has impacted virtually all of the active Army and changed the training paradigm throughout the military.

 

 

Phase I GMPS

Conducting early clinical trials is a means for establishing the initial safety of a drug.  Since these clinical trials are only a sample of the larger, actual trial, these studies generally consist of a small number of healthy subjects, on whom lower doses of the drug product are administered. This means that early clinical trials need only small amounts of investigational material.

The FDA, to help such companies from incurring higher costs, as also to reduce regulatory burden during these early stages, has established guidelines to allow early stage investigational products to be manufactured under what may be considered simulated conditions, i.e., those that require less stringent GMPs.

Understanding the way this system, called Phase I GMPS, is very important, as it sets the path for the fuller development of the drug. A four-hour workshop from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, which is being organized on March 26, will give a thorough understanding of Phase I GMPS.

Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar. Please visit globalcompliancepanel  to register for this valuable session and gain full understanding of Phase I GMPS.

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The aim of this four-hour webinar is to offer a detailed review of everything relating to early stage manufacturing and GMPS, such as the current regulations and guidance documents. Peggy will also review and explain regulatory strategies and logistical considerations for early development stage products. Core considerations of this aspect of early stage manufacturing and Phase I GMPS include vendor selection and management, stability, labeling, and documentation requirements.

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Directors, Managers, as well as supervisors in Regulatory Affairs, manufacturing, Quality Assurance and clinical operations, the primary segment that is expected to benefit from this webinar, will get a complete grasp of the differences between GMP requirements for early and later stage clinical development. The expert at this webinar will help them to explore and discuss ways of developing and implementing strategies for early GMPs for Phase I clinical studies.

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About the Expert:

Peggy J. Berry is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She is the editor of the 2010 book, “Choosing the Right Regulatory Career” and author of the 2011 book, “Communication & Negotiation”. She consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.

 

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.

GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend supporting applications for research or marketing permits for certain classes of products. These include:

• Food and color additives
• Human and animal drugs
• Medical devices for human use
• Biological products and electronic products that are regulated by the FDA.

Joy McElroy, Principal Consultant at Maynard Consulting Company, will, at a marathon four-hour session being organized on March 25 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, explain all the aspects of GLP while giving clarity on how it differs from GMP.

Please visit globalcompliancepanel to register for this important learning, at which the following areas will be covered:

• What are Good Laboratory Practices
• Why were they created
• What is the objective of GLPs and how are they associated with GMPs and SOPs
• Statistical Procedures for data Evaluation
• Instrumentation Validation
• Analytical and laboratory Certification
• Documentation and Maintenance of Records
• Consequences of Noncompliance
• Disqualification and Reinstatement

This webinar is being organized for the benefit of personnel that deal with GLP and GMP in the course of their work, and include Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel, and Auditors.

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About the expert:

With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.