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We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done.
In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.
For more detail please click on this below link:
http://bit.ly/2r9k1XA
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
During the live session, our expert 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 Should You Attend
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.
For more detail please click on this below link:
http://bit.ly/2pFKBFM
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Managers who coach their people become known as good managers to work for, developers of talent, and achievers of business results. They also become better leaders in the process.” -Jack Welch, Former CEO General Electric
Are your people working harder yet performance is still below par? When a leader spends too little time managing performance, here’s what happens. Small sparks turn into creeping flames that, if not doused, quickly grow into raging fires. Work starts slipping through the cracks. Resources are squandered. Deadlines are missed. You’re constantly playing catch up.
Good managers regularly keep each member of their group or team informed about his or her work performance. If this is not done then you probably are going to have problems of employee frustration and low morale, customer complaints or dissatisfaction and unfortunately, more of your time fixing problems rather than getting your work done.
For more detail please click on this below link:
http://bit.ly/2psmWOb
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
The Fair Debt Collection Practices Act is the single most important piece of Federal legislation affecting consumer debt collection. Abide by it and you’re fine. Violate it and the fines can be severe.
This webinar will describe the Act in general. You will learn what you can (and cannot) say and do with regard to consumer debt collection guidelines. In addition, we will discuss tools you can use to more quickly collect on consumer debt…and without going to court in many instances.
Finally, we will discuss the advantages (and disadvantages) of getting judgments, forgiving debt, and how to handle being sued by a debtor for allegedly violating the law.
Why Should You Attend
Consumer debt collector laws are among the most highly-regulated arenas you will ever encounter within the accounting profession. Even though you are legitimately trying to recover money owed to your firm, it can often feel like the debtor has more rights than you do.
Areas Covered in this Webinar
The goal of this webinar is to minimize uncertainty regarding what you are allowed (and not allowed) to say and do. We’ll cover the three major areas of the Fair Debt Collection Practices Act that get even veteran collectors in trouble: Harassment, Unfair Practices, and Illegal 3rd Party Disclosure.
In addition, we’ll examine in detail the different types of bankruptcy law, and how to protect your interests if a debtor includes your firm in a bankruptcy proceeding. We’ll also discuss tools you can use to recover more money quickly without necessarily having to go to court. The pro’s and con’s of securing judgments and forgiving debt will be touched upon, as well as how to handle getting sued by a debtor for allegedly violating statute.
Real-world case studies will be presented that demonstrate just how complex the collections world can be. If you extend credit to consumers, this is a webinar you can’t afford to miss.
Learning Objectives
The Fair Debt Collection Practices Act – Origins and Who It Applies To
“The Big 3” – Areas That Trip Up Even Veteran Collectors…and Staying Compliant
Bad Check Recovery – A Tool You May Not Be Aware Of (Subject to State Law)
Post-Dated Checks – Should You Accept Them?
Bankruptcy – Protecting Your Interests
Judgments and Forgiving Debt
Civil Liability
How to Handle Being Sued Under the Act
Who Will Benefit
CEOs/CFOs
Board Members
Internal Auditors
Compliance Professionals
Operational Professionals
Finance Professionals
For more detail please click on this below link:
http://bit.ly/2oUR9nh
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
Background checks can be a double-edged sword. On one hand, they can be very helpful in reducing the probability of making a poor hiring decision. On the other hand, employers who do not know the state laws or who do not have a fair and consistent process can be fined by the government or a discrimination claim sued by the applicant.
Why Should You Attend
This webinar will describe the landscape of background checks across the country and provide examples of Background Check policies of other companies.
Areas Covered in this Webinar
Deciding whether to do background checks or not
The importance of written policy
Who to check and what to check for
Deciding if it should be done in-house or by a contractor
When the background check should be done during the hiring process
Whether to do employee background checks or not
Cost of doing background checks and not doing them
HR compliance and HR best practices
Learning Objectives
Gain an overall understanding of the pros and cons of background checks
What must be put in place if decide to do background checks
Who Will Benefit
HR Managers
General Managers
Small Business Owners
Hiring and Employment Managers
Talent Management Officers
Risk, Audit and Compliance Personnel
Anyone involved with the hiring and/or retention process at a company
For more detail please click on this below link:
http://bit.ly/2r9cpo3
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
Businesses continue to be assailed by financial frauds. Is your business prepared to identify and mitigate common threats? Are your accounts protected with appropriate security? How would you respond to a threat against your operating account?
This fast-paced, informative session provides businesses with a realistic view of financial fraud today, how fraudsters target business employees, and even analyses the most common frauds by payment system. The bulk of the session focuses on appropriate internal and external controls. Combined, this information helps arm a business with knowledge to implement sound risk management strategies and account controls designed to reduce exposure.
Note: this fraud prevention training only provides a high-level overview of the frauds; the primary focus is on identifying sound risk management practices and controls to reduce exposure to financial fraud and related losses.
Why Should You Attend
Fraud costs businesses financial losses, causes reputational and legal damage, and can even put a business in non-compliance with state and federal consumer protection laws. Simple changes to internal risk management strategies and account controls can put your business in a better position to avoid losses and related fall-out of fraud.
Areas Covered in this Webinar
Index of common frauds by payment system (i.e. cards, ACH, Wire Transfer, etc.)
Security expert findings on the techniques criminals use to initiate attacks
Common practices that can put a company at risk
Sound internal risk management strategies
Exploring external account controls
Incorporating internal fraud assessments into your organization
Tips
Valuable resources
Learning Objectives
Identify the red flags of common forms financial fraud targeting businesses
Assess risky company practices
Review sound risk management strategies and controls to minimize exposure
Assemble action items to improve internal controls and security
Record valuable resources
Who Will Benefit
Operations Managers
Executive Management
Audit / Compliance
Risk management
Lenders / Credit Officers
Treasury / Product Management
For more detail please click on this below link:
http://bit.ly/2qRtx0G
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printing medical devices.
Why Should You Attend
The Food and Drug Administration (FDA) is responsible for the approval of medical devices in the United States of America. Today 3D printing is used in a wide variety of applications, even for the manufacture of medical devices. So what are FDA’s current thoughts regarding the approval of 3D printed medical devices?
Areas Covered in this Webinar
An Introduction to 3D Printing (includes brief history, applications, types of 3D printers, 3D printing process, terminology, advantages and challenges)
An Introduction to Medical Devices & Overview of Medical Device Regulation in USA (what are medical devices, medical device classes and types of medical device submissions to US FDA)
3D Printing of Medical Devices & FDA’s current thoughts (including technical design, manufacture and testing considerations for approval)
Learning Objectives
In this medical device compliance training, medical device manufacturers, software developers, engineers, validation experts, 3D printing raw material manufacturers and suppliers, regulatory and quality professionals, will be informed of FDA’s expectations regarding the design, manufacture and testing of 3D printed medical devices. Those interested in 3D printing technology will be well briefed too.
Who Will Benefit
The following professionals from the Medical Device industry will benefit from this training:
Manufacturing
Production
Product management
R&D
Software developers and vendors
Engineers
Validation experts
3D printing raw material manufacturers and suppliers
Regulatory and quality professionals
Anyone interested in 3D printing technology and / or medical devices
For more detail please click on this below link:
http://bit.ly/2pWRCE3
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
The IRS thinks Forms 1099 are important. They asked and Congress agreed to increase the failure to timely file and the failure to file a correct Information Return penalties for Information Forms.
Form 1099 Due Diligence – Those steps you must take if you want to request abatement of IRS Form 1099 penalties due to reasonable cause. Exercising due diligence, due care in following procedures saves time and money.
Why Should You Attend
Develop Good Procedures for Solicitation of W-9 Forms
Develop Procedures for Review of Incoming W-9 Forms
Determine When to Return Incorrect or Incomplete W-9 Forms
Use IRS e-Services to Avoid TIN and Name Matching Problems
Guidelines for Instituting Backup Withholding tax Procedures
What to do When You Receive a Notice 2100/2100A
Areas Covered in this Webinar
Most Common 1099 Mistakes
Current Responsibility of Income Tax Preparer as Well as Payer
Compliance requirements of Payers
W-9, first step to accurate Forms 1099
Tips for Avoiding IRS B-Notices
Tips for Avoiding Increased IRS Penalties
Learning Objectives
Identifying Types of Payments Requiring 1099s
Identifying Types of Entities Who Should Receive a 1099
Developing Best Practices for Preparation of Forms 1099
Potential Penalties for Payer and Tips to Avoid Penalties
Who Will Benefit
CPA and Accounting Staff
Enrolled Agent and Staff
Attorney and Staff
Bookkeeping Service Companies
Corporate Accounts Payable Staff
Non-Profit Accounting Staff
Any Person or Department responsible for sending out Forms W-9 and Forms 1099
For more detail please click on this below link:
http://bit.ly/2plHPWd
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
The US FDA expects that as part of a product development Design Control Program risk management will be conducted.
FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.
One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.
In this ISO 14971 risk management training we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. Also, how to deal with residual risk will be discussed. We will go step by step through a typical hazard analysis.
We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.
Why Should You Attend
FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. we will explain these concepts and provide examples so that the process is clear.
Areas Covered in this Webinar
explanation of Hazard Analysis terms hazard analysis process explanation using a template examples of terms will be given hazard analysis examples will be covered step by step
Learning Objectives
Learn to conduct a meaningful hazard analysis
Who Will Benefit
Engineering personnel
Software developers
QA
Management
For more detail please click on this below link:
http://bit.ly/2moVzlU
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
The only constant today is change…and with regards to document retention policy and privacy, laws, regulations are changing all of the time. You need to be diligent to know how, and if, your current policy is affected by these changes.
Retention and management of records is more complicated than just deciding what to keep and for how long. In what form should records be kept? Should we keep more than what the regulations require? If so, what? What about possible litigation needs? Examiner expectations must be met, of course, but other parties, such as law enforcement, auditors, and those representing your employees may require access to information, as well.
Why Should You Attend
To manage an effective program in a cost-effective manner, compliance professionals must rely on information from a broad range of resources within the organization. Records management is the point of convergence of these resources, which is why effective and reliable records management training must be part of your Compliance Program.
Areas Covered in this Webinar
Specific tips for business records retention practices that both strengthen your process and standardize your records management program
How to plan for worst case scenarios
Developing records retention schedules
The key elements of a security assessment of your plan
Learning Objectives
Retention basics: What should you keep and for how long?
What about HIPPA compliance training and medical records?
What is Personally Identifiable Information (PII training)?
Privacy laws: What is the Gramm-Leach-Bliley Act and why should I care?
How do I protect myself, my business, and how do I get started?
Electronic records retention, promises and problems
Who Will Benefit
Compliance Officers
Auditors
Information Security and Management Personnel
IT Personnel
Senior Management
Operations Professionals
Human Resources Professionals
Anyone involved in the Creation, Management, and Destruction of Information and Records
For more detail please click on this below link:
http://bit.ly/2qRFNOV
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
0 notes
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Overview
You already know if the violence erupts in your workplace the consequences can be unpredictable, and can be severe. These include, but are not limited to, injuries or death of employees, customers, and/or visitors from workplace violence, in lawsuits, property damage, increased insurance premiums, OSHA enforcement actions, increases employee turnover and reduced community trust.
In most workplaces where risk factors can be identified, the risk of assault can be prevented or minimized if employers know and take appropriate precautions.
One of the best protections employers can offer their workers is to establish a written policy toward workplace violence, covering all workers, patients, clients, visitors, contractors, and anyone else who may come in contact with company personnel. A low-cost workplace violence prevention program, combined with engineering controls, administrative controls and training can reduce the incidence of workplace violence in both private sector and government workplaces.
Why Should You Attend
This anti harassment training offers employers low- and no-cost ideas and resources for starting a workplace violence prevention and mitigation program.
Even though your organization may not be at high risk for violence, because the consequences can be devastating, protecting your team is just good business. And while nobody disputes the importance or preventing workplace violence, all too often it is not considered urgent. Except after the fact, when it is too late.
Every dollar spent on one thing is a dollar you don’t have to spend on something else. Will you have a workplace violence incident next month? Probably not. But for sure there’ll be payroll, insurance, rent, etc. that must be covered. Pay them or go out of business. But crossing your fingers and hoping for the best is not going to prevent or mitigate violence.
Areas Covered in this Webinar
This webinar will address the key elements of violence management: prevention, mitigation, and response.
Free or low cost ways to conduct risk analysis, secure the business premises, create polices, conduct safety training and keep your facilities and people safe from violence will be covered.
Resources available from OSHA, NIOSH, the FBI and other organizations will be reviewed.
Learning Objectives
After participating in this workplace violence and harassment training, you will be able to describe, outline and/or discuss-
· The Scope, Impact and Typology of Workplace Violence
· Workplace Violence Plans, Policies and Procedures
· Worksite Violence Risk Analysis Tips
· Hazard Prevention & Control Methods
· Personal Safety Training- Low-cost and Free Resources
· Recordkeeping & Evaluation
· Responding to Workplace Violence Incidents
Who Will Benefit
Security, Human Resources, Safety, Facilities/Maintenance, Risk Management/Legal, Counseling/Mental Health, and Operations.
For more detail please click on this below link:
http://bit.ly/2pKyvPA
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Overview
In recent years, the health care industry has seen unprecedented levels of physician employment. Structuring employment arrangements appropriately and periodically auditing implementation are critical in today’s challenging enforcement climate.
Why Should You Attend
As health care organizations and physicians develop employment arrangements, they must manage their compliance and enterprise risk by ensuring the employment is defensible under the Stark Law.
Prior to moving forward with any employment arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark’s technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the arrangement is ever challenged.
This Stark Law webinar will focus on underlying technical requirements and key tenets of defensibility as they apply to physician employment arrangements.
Areas Covered in this Webinar
· Provide a general Stark Law overview.
· Examine critical components of Stark compliant employment arrangements
· Discuss best practices for drafting employment agreements and the related financial terms
· Describe best practices for auditing employment agreements
· Review processes for documenting fair market value and commercial reasonableness
· Discuss best practices for auditing existing arrangements and potential pitfalls
Learning Objectives
In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes.
He will also discuss best practices for negotiating and drafting employment agreements on behalf of health systems, hospitals, medical groups and physician practices.
The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.
Who Will Benefit
· In-House Counsel
· Health Care Compliance Officers
· Health Care Human Resources
· Health Care CFOs
· Health Care executives
For more detail please click on this below link:
http://bit.ly/2qCSqgA
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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In today’s busy corporate environment staff is moving in many directions at the same time, incurring expenses that require expense reimbursement. Organizations need to ensure that its expense reimbursement policy is followed through proper monitoring and oversight to avoid expense reimbursement fraud.
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Overview
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.
Why Should You Attend
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance; your firm’s CAPA system is useful and meaningful.
Areas Covered in this Webinar
Regulatory Requirements
FDA QSR
ISO 13485
Elements of a cross-procedural CAPA program
Applications of CAPA
CAPA Data and best practices for its use
Application of risk management to CAPA program
For more detail please click on this below link:
http://bit.ly/2p03szK
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
0 notes
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Overview
This Incoterms training 2010-Term of Sales will address how the exporter must know the condition of sales at the point of the exporting transaction prior to the exportation process. ��
It will discuss why the exporter must be familiar with the Incoterms that are described as the three-letter trade terms that define the buyer and seller’s responsibilities in international business transactions.
Lastly, we also explain what expected terms of sales are acceptable on the shipping documentation to meet Customs assessment requirements.
Why Should You Attend
The exporter may not know what Incoterms are appropriately acceptable as international shipping process or delivery terms and what are the standard practices in the usage of the terms in an exporting environment.
This exporting terms analysis will help to explain the best reason both the buyer and seller must understand their obligations when it comes to the delivery of the goods. As a result, exporter must be aware of the preferred terms to use as seller and the preferred terms that must be used for buyers during the delivery process because the terms will allocate the responsibilities and risks of each party.
We will also address why the important of the pricing and sales agreement in the terms of sales from a foreign buyer point of view their costs within the landing charges to the port of arrival.
Lastly, we will discuss the miscellaneous costs that are associated the storage and handling charges that might incur in the shipment process.
Areas Covered in this Webinar
What are the terms that can be used for inland and sea transactions?
Which party should purchase marine insurance for each shipping elements prior to delivery operations?
How can each party reduce the risk of losses and damage goods during shipment process?
Which party is responsible for paying the cost of carriage when various intermodals are used in the channel of the distribution process?
What are the minimum obligation for each party during when it comes to paying the delivery duties in the exportation process?
For more detail please click on this below link:
http://bit.ly/2nLzsr7
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
0 notes
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Overview
Investigators must obtain information to investigate. Investigative information is gleaned from a variety of sources, documents, computers, cell phones, trace evidence, and people. As of today, and for the foreseeable future, it is people who commit violations, witness violations, and have information concerning violations you are investigating, whether it is a crime of a violation of company policy. It is important to understand that not everybody you talk to is a suspect. When preparing a Case Plan, careful attention must be given to the Interview Strategy, including who to interview and in what order the interviews should take place. It is equally important to understand why certain individual need to be interviewed and what questions need to be asked to achieve your interview objective. In addition, the interview method (i.e. recorded, formal, informal,) and the location of the interviews must be determined.
Why Should You Attend
Interviewing is not a peripheral task that is undertaken in the wake of conducting an investigation. Interviewing is a critical component of an investigation. The successful conclusion of the matter you are investigating often rests with the quality of your interviews. Without a doubt the best investigators are the ones with the best interview skills, which includes preparing and developing a well thought out Interview Strategy.
This interview training for employers will provide with the tools to develop an Interview Strategy as part of a Case Plan. The webinar will discuss the various categories of interviewees that investigators will need to talk to in typical investigations. Furthermore, the webinar will discuss the importance of understanding why an interviewee needs to be interviewed and how to develop a pertinent topic/questions list tailored to each interviewee to assist in reaching the interview objective. In addition, the webinar will discuss interview best practices as it relates to room setting, note taking, recording, and the number of interviewers.
Also, the webinar will provide insight as to what motivates an interviewee to be less than candid and what motivates an interviewee to be truthful. (It’s not only suspects who will lie and be deceptive.)
Areas Covered in this Webinar
This webinar will cover the following areas.
Who: The different categories of interviewees when conducting an investigation (not everybody is a suspect)
Why: The importance of knowing “why” you want to interview a particular individual. (It seems simple, but you would be surprised that this important factor is often overlooked)
What: The importance of having an Interview Objective when preparing for each interview (interviews can have multiple objectives).
When: How to strategically determine the order of interviewees when initiating an investigation.
Where: To determine if the interview should be formal or informal. Whether the interview is in a controlled setting on your turf, or on the interviewee’s turf, or at a neutral location.
How: to determine if the interview is conducted by telephone, in person, with more than one interviewer, and whether or not the interview should be recorded.
In addition, you will learn the critical importance of preparing for an interview, and how to prepare.
How to create an Effective Topic/Question List in preparation for an interview.
For more detail please click on this below link:
http://bit.ly/2oFO1bx
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
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Would you like to be able to more effectively:
Understand the complete and critical steps of the 360 degree feedback process
Learn the keys to identifying an effective 360 degree feedback instrument
Access important information regarding the selection of raters – those who rate the person receiving 360 degree feedback
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