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Root Cause Analysis and CAPA

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Description :

Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from an industry expert with over 30 years’ experience. You will learn how to get permanent resolution to your serious quality problems.

CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems. This webinar will help you improve your root cause analysis leading to real and lasting improvements.

Objectives :

  • FDA Expectations
  • A Methodical Process for Root Cause Analysis
  • Root Cause Analysis Techniques
  • Do’s and Don’ts
  • Myths of Root Cause Analysis
  • Documentation Expectations

Topics :

Build the right team
Develop a problem statement
Data Collection
Analysis Tools and Techniques
How to Verify your Results

Instructor Profile:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.  She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.  While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.   Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.  She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.  Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.  Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

For more information click here: Root Cause Analysis and CAPA

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Payroll Deductions:What Can and Cannot be Deducted from an Employee’s Wages 2017

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Description:

In payroll we calculate the gross wages of an employee by meticulously following strict regulations on what must be or must not be counted as hours worked and taxable income.  We pay the employee their net paycheck only by the payment method that is permitted.  But what about in between?  When it comes to deducting from the employee’s gross wages to achieve the net income are you also adhering strictly to the rules?

Failure to follow the regulations pertaining to employee wage deductions can result in substantial penalties and interest. Attend this 90 minute presentation to gain knowledge to protect your company.

AREAS COVERED IN THE WEBINAR:

•    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?
•    Loans to employees: what terms can be set while the employee is still active and what can be taken when the employee terminates
•    Employee purchases—active employees and terminated employees
•    Anti-wage theft laws and the states

INSTRUCTOR PROFILE:

Vicki M. Lambert, CPP, is President and Academic Director of The Payroll Advisor™, a firm specializing in payroll education and training. The company’s website http://www.thepayrolladvisor.com offers a payroll news service which keeps payroll professionals up-to-date on the latest rules and regulations.

With over 35 years of hands-on experience in all facets of payroll functions as well as over 20 years 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. She is also the Program Developer, Subject Matter Expert (SME), and Facilitator for the Certificate in Payroll Practice and Management Program offered by Cengage Learning / Ed2Go through hundreds of colleges and universities across the country.

For More Details Click here:Payroll Deductions:What Can and Cannot be Deducted from an Employee’s Wages 2017

Form I-9 and E-Verify, getting and staying compliant

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Description:

Employers are required to complete an I-9 form for every person they hire and to update these forms when necessary. Periodically, the DHS, the Department of Labor and the Justice Department send Notices of Inspection to employers to audit their I-9 forms. If the I-9 forms are not completed correctly, an employer may be fined even if all their employees are legally authorized to work in the U.S.  In fact, Congress gave the DHS authority to increase penalty thresholds by more than 200% to account for inflation. But the horizon for I-9 compliance is ever dynamic, recently the Fifth Circuit issued a decision regarding I-9 compliance that promises to have reaching impact to the employer.

Beginning on May 7, 2013, all employers were required to use the then released Form I-9. The new Form I-9 was longer and more complex than the previous version and came with new rules affecting which documents may be used to verify the employment eligibility of workers. There were also new instructions and additional data fields for employees and employers. Equally as important to note was the authorization by OMB in late August for DHS to move forward with yet another Form I-9 which is expected to be released sometime before the end of November. During this webinar participants are walked through the changes to the form and are informed of the proposed changes yet to come to improve overall I-9 compliance.

Whether your employees complete Form I-9 centrally or on the jobsite, this webinar is a must for anyone who is responsible for completing and signing Form I-9.

Topics Covered:

•    Up-to-date I-9 compliance requirements
•    Basic I-9 document review
•    Overview of the proposed changes for a new Form I-9, billed as the “smart” form
•    Highlights of the OMB review and approval for the “smart” form along with the recently increased penalties authorized by Congress
•    An overview of the decision handed down by the Fifth Circuit regarding corporate I-9 attestations
•    Recognize the effect of the new Form I-9 on hiring managers and field personnel;
•    Understand the new rules for acceptable documents used to verify employment eligibility;
•    E-Verify – Pros & Cons
•    Understand the impact the new Form I-9 will have on the use of E-Verify;
•    Conducting a self-audit of your I-9 process
•    How to avoid the common errors and omissions, including recordkeeping errors
•    Update on Upcoming ICE I-9 audits
•    Penalties for non-compliance
•    Understanding Civil & Criminal Penalties
•    Walking the fine line between vigilance and illegal overstep when seeking proof of citizenship
•    Establish best practices for reducing risks and correcting errors when using the new Form I-9.

 Long Description:

The United States Immigration and Customs Enforcement (ICE) has cracked down on companies suspected of hiring illegal workers and greatly increased their number of annual audits. Most recently, the Indian company Infosys was ordered to pay a record $34 million settlement after allegations of systematic visa fraud and abuse of immigration processes.

Implementing Form I-9 compliance and best practices while limiting your company’s liability is a challenge faced by many employers. To help, DHS has posted links to various online resources.  As good as these short videos are, I-9 compliance is a complex procedure, and although the videos do a great job in introducing employers to the basics, there are hundreds of technicalities that are not covered in their videos.

For example, there is a box on Part I of the form for persons who are noncitizen nationals to check.  I would venture to guess that 99.9% of employers (and probably most DHS employees) have no idea what a noncitizen national is.

Also, many rules for completing I-9 forms are not listed in the law or even in the USCIS regulations. When can an H-1B employee who is changing jobs start working for the new employer?  What forms does he have to present to show that he is authorized to be employed for I-9 purposes?  These type of questions are not covered in the videos.

Today, in order to avoid astronomical fines for non-compliance, employers need to be ever so vigilant and diligent in their process. The webinar discussion will include a review of the penalties ICE and Office of Special Counsel (OSC) can impose. Additionally, the webinar will review paper versus electronic I-9 forms and the common missteps employers make in the process.

Learning objectives:

(This will inform about what attendees will learn by attending this webinar. It can be in bulleted points or descriptive type. 3-4 pointers or lines are sufficient)

Form I-9

•    Background
•    Completing Form I-9
•    Storage and Retention

E-Verify

•    The big picture
•    Enrolment and Use
•    Additional Information

Who will benefit:

•    CFOs
•    Payroll and accounting managers
•    Payroll processing professionals
•    Employers and Business owners
•    Human Resources Specialists and managers
•    E-Verify Users
•    Anyone interested in learning about the Form I-9

Instructor Profile:

Cathleen Hampton has more than 25 years of experience as a human resources professional providing subject matter expertise and consulting services in areas of risk and compliance, work force planning, and human capital strategy. She has a unique ability to analyze operations for risk and help maneuver cultural practices and compliance enhancements that increase organizational outcomes.  She is a well-known speaker noted for presenting best-in-practice solutions focused on talent retention and operational strategies that outpaced major completion through strong and decisive business leadership.

For More Details Click Here: Form I-9 and E-Verify, getting and staying compliant

AML/BSA Requirements for Privately Owned ATMs

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Description:

This session highlights understanding and mitigating the risks of POATMs that are being acknowledged and recognized by regulators and examiners.
In this webinar, we will discuss the areas that regulators and examiners are primarily focusing on in regards to POATMs. The areas of focus outlined in this webinar are based on best industry practices and supervisory experience

Why You should Attend The Session :

Financial institutions are required to be compliant with BSA rules and regulations. Such compliance needs to be well documented and consistent to ensure financial institutions are adequately identifying POATM customers and mitigating those risks.
Financial institutions’ BSA POATM program must be included in the bank’s policies and procedures, comprehensive risk assessments, and monitoring programs.

Areas Covered During The Session:

Implementing BSA compliance practices on privately owned ATMs
Assessing policies and procedures regarding POATMs
Determining effectiveness and thoroughness of training programs
Ensuring qualified employee oversight of daily BSA operations regarding POATMs
Independent testing

Instructor Profile:

Dr Gina J. Lowdermilk, PhD (ABD), CAMS, CRMS is a highly experienced and educated BSA/AML and financial regulatory compliance professional with extensive experience in policy and procedure development and implementation, training, internal audit, monitoring, risk management, and reporting . Her emphasis has been working with financial institutions that are experiencing regulatory concerns and resolutions, including enforcement actions such as memorandums of understanding and cease and desist orders. Her 15 years of experience has given her the opportunity to work from small community banks to large, international financial institutions. Her roles not only included BSA/AML and compliance, but also operations, lending services, business development, marketing, management, department development, and asset quality.

Ms. Lowdermilk has worked with almost all financial regulators and examiners. She possesses advanced Microsoft Excel, PowerPoint, Word, Internet Explorer, Visio, and Access skills. She also has experience with FiServ, BAM, CRA Wiz, TeamMate, COGNOS, and Metavante banking software. She has been responsible for creating both recurring and ad hoc executive management and board presentations. In addition to her above experience, she is also an adjunct instructor for the business and construction management programs at a local college, as well as writes numerous BSA/AML and compliance articles, training materials, and manuals for numerous clients.

For More Details Click Here : AML/BSA Requirements for Privately Owned ATMs

 

The Ultimate Guide to Navigating California Medical Leaves

Description:

  This comprehensive interactive training workshop will help clarify California specific leaves, how they interact with the Federal medical leaves and how to apply leaves concurrently where applicable, specifically the challenge when transitioning from FMLA to ADA.

Why should you attend:

Do you feel lost when it comes to employees who are out on medical leaves? Are you not sure which leaves apply to your employees and how? Do you have employees who abuse medical leaves because your policies are not clear?  Do you confidently know how to require employees to cure incomplete medical certificates or when to get second opinions?  Do you know when you can deny leave? Are you comfortable with the risks associated with terminating an employee for abuse of leave? Do you refrain from terminating underperforming employees who have been (or are on) FMLA/ADA leave because you are concerned about staying in compliance with all of the laws and regulations that apply to employee termination? Or maybe you’ve felt it’s just too hard to find the time to stay on top of these leaves and control the absences!

This interactive training workshop will provide comprehensive step by step procedures, Ms. De Lima will enable you to navigate the complex (and sometimes dangerous) network of mazes that the road of California specific leaves can take, allowing you to navigate the maze with confidence.  Throughout the workshop, we will focus on how California leaves such as FEHA and CFRA interact with Federal medical leaves, such as the FMLA and ADA. Learn which leaves can run concurrently, how to make the transition from one leave to the next and what you need to document to protect yourself and your organization.

Drawing from real life scenarios, this workshop will provide you with exposure to Ms. De Lima’s Integrated Leave Management Process that include a well developed, detailed documentation processes that can easily take you through your Medical Leave travels in California and explicitly document your activities in confidence.

You’ll discover that when you clearly document the entire process in a consistent and meticulous manner, you can protect your organization from potential litigation should the need to terminate arise

Areas Covered in the Session:

•    Overview of CA Specific leave laws – PDL, CFRA, FMLA, ADA, FEHA and PFL
•    Explanation of their interaction with Federal leave laws – FMLA, ADA and Workers’ Compensation
•    How to apply leaves that run concurrently
•    How to document the transition from one leave type to the next
•    Specific rights you have as an employer to deny leave for employees who use more leave than the certificate allows
•    Method for curing medical certificate or getting second and third opinions
•    Simple strategies to manage the medical leaves in a consistent manner to avoid expensive litigation and preserve the employer-employee relationship
•    Exposure to the various forms, letters and documentation that Ms. De Lima has perfected over 22 years of consulting in the ADA, FMLA, and Workers’ Compensation arena.
•    Guidance from an in-the-trenches HR Expert Witness on how to maintain pristine documentation in an efficient and effective way to avoid costly litigation
•    Take home suggestions on how to integrate your leave policies to assure you are maximizing leave time that can run concurrently for your employees
•    Obtain money saving strategies that help HR show a positive impact on the bottom line
•    Real life scenarios designed for you to walk away with the skills and tools needed to immediately apply the strategies presented so you can start controlling the Medical Absence in your own workplace.

Who will benefit: 

This webinar will provide valuable assistance to all companies, not-for-profits, school districts, governmental agencies and pseudo governmental agencies.
Those that would benefit most would be the following positions located in California or with Employees in California:

•    Human Resource Managers / Administration
•    Risk Managers
•    Benefit Specialists
•    Supervisors
•    Business Owners
•    General Managers
•    Controllers/ CFOs / Financial Managers

Instructor Profile: 

Speaker, Beth Brascugli De Lima, M.B.A., SPHR-CA, SHRM-SCP, is founder, president, and principal of HRM Consulting, Inc., a California-based human resource consulting firm. Ms. De Lima provides corporate consulting on a national basis regarding employment regulations, compliance and vocational rehabilitation.  This seminar is an opportunity for HR and Payroll professionals to learn strategies for consistent application of compliance regulations from an in-the-trenches HR Expert who is regularly called on to testify in court for employment litigation. Her organization has assisted corporate, not-for-profit, school districts, and governmental clients with Human Resource policy development and implementation since 1992 on a national, statewide, and local level.

Ms. De Lima has extensive experience in all areas of employment litigation including the Americans with Disabilities Act (ADA), Family Medical Leave Act (FMLA), and Workers’ Compensation and is a recognized expert regarding Medical Leave Management employment law compliance.  Ms. De Lima provides expert testimony for both plaintiff and defense regarding Human Resource Best Practices and Standards of Care. Her focus is to assist organizations with mitigating potential liability by offering consulting services, mediation, and interactive training to organizations, not-for-profits, government and pseudo government entities, attorneys, and school districts.

For More Details Click here: The Ultimate Guide to Navigating California Medical Leaves

Process Validation for Drugs and Biologics

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Description:

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management.

Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.

Course Objective:

Upon completing this course participants should:

•    Understand the new FDA perspective of a “Process Validation Life-Cycle” that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness) as stated by the FDA’s new Guideline on Process Validation and its impact on how process validation activities are carried out
•    Understand the perspective of the EMEA, ICH, WHO and PIC/S on process validation and how they can be incorporated into a single process validation system
•    Be able to set up process validation programs and corresponding documentation including protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
•    Prepare and defend your own process validation approach/program and avoid costly delays and rejections by regulatory agencies

Course Outline:

I. Introduction to Process Validation

•    Regulatory Perspective – Biologics vs. Pharma
o    Defining Validation
o    Recognize the role process validation plays in understanding process and product variability – Making the Validation Fit Your Product
o    Types of Process Validation – Retrospective – Concurrent – Prospective
o    Understand the perspectives of the FDA, international regulators and the GHTF

II. Implementing a Process Validation System

•    Establishing the Infrastructure
o    The process validation procedure
o    Roles and responsibilities
o    Equipment and facilities
•    Process Validation Requirements
o    Requirements of Title 21
o    Review of the FDA Guidance on Process Validation
o    Differences between Regulatory Agencies Requirements
    ICH
    EMEA
    PIC/S

III. Executing a Validation

•    Other Related Components of Validation
o    Facility Validations
o    Cleaning Validations
o    Processing Equipment Validations
o    Viral Clearance Validation
o    Sterilization Validation
o    Packaging Validations
o    Computer System Validation

IV. Supplier Process Validations

•    Requirements of Suppliers
o    Validation based on supplier criticality
o    Role of Quality Agreement in Process Validation
o    Communication of process changes
o    Inspection vs Validation of supplied components

V. The Validation Life Cycle

•    Re-validation

o    When, why and what
o    Handling problems during re-validation
o    Product and process implications

•    Product complaints and process failures

o    Evaluating process parameters as a cause of product failures
o    Process change history
o    Amending the existing MVP

•    Implementing the System

o    Assessing the status of existing systems
o    Identifying the systems to be validated
o    Determining when revalidation is required
o    Defining and controlling the Master Validation Plan (MVP)
o    An audit perspective of the MVP

VI. Process Validation Compliance

•    Avenues for Assessing Compliance
o    Internal audits
o    Complaints and corrective action
o    Process changes
o    Process FMEA
o    Review of recent Warning Letters and Consent Decrees

Target Audience:

Attendance to this 3 hour webinar will be beneficial to personnel directly involved in process/product development, manufacturing, quality control/assurance and process validation. This includes both beginners and seasoned operational personnel who conduct process validations. Individuals in management who interact with previously mentioned staff or communicate with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course.

Participants should be familiar with FDA, ISO and EMEA requirements for process validation and have a good understanding of the Pharmaceutical and/or biologic Good Manufacturing Practices.

•    QA and QC managers
•    Quality Engineers
•    Validation managers
•    Validation Engineers and Specialist
•    Operations managers
•    Regulatory compliance managers and personnel

Instructor Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.

Now with 12 years experience as a consultant, and 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, Phillips Medisize, Xcelience, and Novartis.

Joy specializes in Equipment Qualification, Cleaning Validation, Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

For More Details Click Here: Process Validation for Drugs and Biologics

Investigating OOS Results

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Description:

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Why should you attend:

The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.

Areas covered:

* FDA requirements for handling OOS/ OOT results
* Phase I- Laboratory Phase of Investigations
* Phase II a Full Scale Investigation
* Concluding an Investigation
* Out-of Trend investigations
* Common pitfalls during OOS Investigations
* Review of recent OOS related citations in Warning Letters

Benefits/Target Audience:

•QA managers and personnel
•Analysts and lab managers
•CAPA management
•Regulatory affairs
•Training departments

Instructor Profile:

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients.  In the years after, she has held positions in the Quality management arena while increasing her responsibility.  She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

For More Details Click Here : Investigating OOS Results

 

1099 and W9 Update

Description:

For years the IRS has struggled with the independent contractor and tax collection.  In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding the information reporting on taxpayers by payors – the 1099.  This time consuming reporting obligation can be streamlined in a number of ways.  Join us to learn more…

Why Should You Attend:
What are the rules regarding paying and IRS reporting on Independent Contractors?  How do I avoid the IRS CP-2100 (B-Notices)? What if my vendor claims exemption; must I obtain a W-9 anyway?  What are the best practices? How can I minimize risk of improper exemption claims by my vendors? Get the answers to these and related questions to reduce your risk of huge penalties from the IRS.
Learn the rules requiring W-9 documentation and 1099 reporting.  Learn how to establish the independent contractor relationship with the right documentation. Understand the rules and keep your company in compliance.  Ensure that your records will stand the scrutiny of an IRS 3rd Party Documentation and Reporting audit.  Avoid the onerous penalties for noncompliance and build the best defense against the 972-CG Notice of Proposed Penalty Letter.

Areas Covered in the Seminar:
In just ninety minutes you will gain the following insights:

•    Starter Question: How can we best set up an independent contractor in our vendor payment system to ensure compliance with the IRS reporting rules?
•     Protocols for setting up new vendors (ICs)
•    When to require a Form W-9
•    How to test the accuracy of the W-9 information with the IRS’s records – for free!
•    Who and what you pay determines whether you must report (1099 reporting)
•    Forms to use to document your independent contractor as reportable or non-reportable
•    Required governmental reporting on ICs
•    Form 1099-Misc – guidelines for proper use and classification of diverse payments on this form
•    Best practices for filing 1099s with the IRS – TIP: never file early!
•    The government wants to remove the exemptions – what this means to you

Who Will Benefit:
•    Bank Managers
•    Compliance Officers
•    Information Reporting Officers
•    Tax Managers
•    CFOs
•    Controllers
•    Accounting Managers
•    Auditors
•    IT Managers
•    Compliance Managers
•    Risk Managers
Target Companies and Associations – (Please Mention If Any )
•    All types of entities including For Profit, Not for Profit, Government (Federal and State) – everyone who hires an independent contractor has reporting obligations
•    AICPA, CGMA, IOMA, TAPN

Topic Background:
For years the IRS has struggled with the independent contractor and tax collection.  In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding the information reporting on taxpayers by payors – the 1099.  This time consuming reporting obligation can be streamlined in a number of ways.  Join us to learn more…

Instructor Profile:
By Miles Hutchinson, CGMA
President
Sales Tax Advisors, Inc.
Miles Hutchinson is a CGMA and experienced businessman. He has been an auditor with PriceWaterhouseCoopers and the Chief Financial Officer of a $1 billion real estate development company. Miles is a professional speaker and consultant who has presented over 2,000 seminars and training sessions on a myriad of business and financial topics, like financial analysis and modeling, accounting, strategic planning, and compliance with the Sarbanes-Oxley Act.  He is recognized as an expert in payroll and sales & use tax as well as financial modeling & analysis, business strategy and communications.  He is the author of several useful accounting and tax tools available at http://www.soxpolicies.com and http://www.salestaxadvisors.com.  His clients include, Abbott Labs, Bank of America, Boston Scientific, Citicorp, Corning, the FBI, the FDA, the Federal Reserve, GE, Pfizer, Siemens, US Marine Corps, and the US Army.

For More Details: 1099 and W9 Update

Email: david@grcts.com
Tel: +1-248-233-2049
Web: http://www.grcts.com

Travel Pay: Handling it Correctly

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Description:
How to compensate employees for the hours spent traveling on business is becoming one of the major concerns of the payroll department today.  Many recent changes in federal and state wage and hour rules as well as economic pressures on employers and employees alike can create a situation that can practically invite noncompliance lawsuits—especially if the travel time results in overtime being owed to the employee.
But it isn’t just the DOL that is interested in travel pay. The IRS also has strict regulations on when employees can be paid for travel expenses without it being considered wages. Does the company use the per diem method to reimburse employees or the accountable plan method?  Or do you even need to have a method when it comes to reimbursing employees for travel expenses?
This webinar discusses the rules and regulations that must be followed when paying an employee for travel pay. It includes what is travel pay, best practices for handling the payments, how it affects overtime calculations and what is required on the state level. It also discusses the requirements for taxing travel expenses under IRS rules.

Areas covered in the presentation:
•    Travel pay requirements—What you must pay for and why
•    Best practices for paying travel pay correctly
•    Which employees have to be paid…and when
•    Payroll Compliance and travel pay issues—keeping wage and hour claims at bay
•    What to do when federal and state laws conflict and handling multiple state conflict issues
•    How travel pay affects overtime calculations—travel pay differences for exempt and non-exempt employees
•    Special circumstances that may require travel payment
•    What are per diems
•    When travel payments are taxable
•    Accountable and nonaccountable plans

Target Audience:

  • Payroll professionals
  • Human resources
  • Accounting personnel
  • Business owners
  • Lawmakers/Attorneys

Instructor Profile:
Vicki M. Lambert, CPP, is President and Academic Director of The Payroll Advisor™, a firm specializing in payroll education and training. The company’s website http://www.thepayrolladvisor.com offers a payroll news service which keeps payroll professionals up-to-date on the latest rules and regulations.
With over 35 years of hands-on experience in all facets of payroll functions as well as over 20 years 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. She is also the Program Developer, Subject Matter Expert (SME), and Facilitator for the Certificate in Payroll Practice and Management Program offered by Cengage Learning / Ed2Go through hundreds of colleges and universities across the country.

For More Details: Travel Pay: Handling it Correctly

Email: david@grcts.com
Tel: +1-248-233-2049
Web: http://www.grcts.com

510(K) Submission – A Comprehensive and an Updated Overview

510k-submission-a-comprehensive-and-an-updated-overview

Why should you attend:

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).  The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3).  In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.

To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance in view of recent trends and customized strategy for a successful clearance.

This presentation is intended to demonstrate how to improve submission quality, which will subsequently prevent avoidable delays and reduce review times.
In this webinar, we will discuss:

  • Statute(s) and Regulations
  • Definitions
  • Medical Device Classification
  • 510(k) Process
  • Selecting Predicate Device(s)
  • De Novo Process – Practical Advice
  • How To Demonstrate Substantial Equivalence
  • 510(K) Contents And Format
  • Addressing Technical And Regulatory Requirements.
  • 510(k) Submission Quality For A Product-Be Aware.
  • Responding to FDA’s Request Of Additional Information.
  • Resolving Different Opinions Between The Submitter And FDA Reviewer(S).
  • Avoiding Common Mistakes with Awareness
  • 510(k) Trends
  • 510(k) Preparation: Dos and Don’ts for Best Practices
  • Speaker’s PASS-IT Recommendations

This webinar will provide valuable assistance and great opportunities to all personnel involved as further described below.

This webinar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics and in vitro diagnostic devices. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products. This webinar is a must for those who are directly or indirectly involved in handling 510(k) regulatory submissions to the FDA.

Who will benefit: 

  • Personnel involved in regulatory affairs (associates, specialists, managers, and directors).
  • Personnel involved in clinical affairs (associates, specialists, coordinators, managers and directors)
  • Personnel involved in quality assurance, quality control and quality systems (associates, specialists, engineers, managers, and directors)
  • Personnel involved in research and development (associates, scientists, managers, and directors)
  • Site managers, and consultants
  • Other interested stakeholders (upper management personnel)

For More Details:510(K) Submission – A Comprehensive and an Updated Overview

Email: david@grcts.com
Tel: +1-248-233-2049
Web: http://www.grcts.com