WEBINARS

 

Compliance Training Webinars for Regulated Industries

1099 & W-9 Update - Complying with IRS Information Reporting Guidelines

webinar-speaker   Miles Hutchinson

webinar-time   90 Min

Product Id: 703220

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…

30 / Nov / 2021 - Tuesday

* Per Attendee $199

 

If It Wasn't Documented It Didn't Happen: Legal & Effective Discipline & Documentation

webinar-speaker   Melveen Stevenson

webinar-time   60 Min

Product Id: 701495

This webinar will help managers master the art and science of performance documentation. You will learn about safe, legal, & effective disciplinary practices & documentation.

1 / Dec / 2021 - Wednesday

* Per Attendee $179

 

HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 705214

There are several steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforward, but there are guidelines to follow to help at every step of the way. If the evaluation of necessity to report is not done correctly, you may not make the right decisions about reporting and be subject to penalties for non-compliance upon an investigation of a breach by HHS. Penalties for non-compliance can up to millions of dollars in cases of willful negligence, so it is essential to evaluate incidents to see if they are reportable breaches, and act properly on the evaluation.

1 / Dec / 2021 - Wednesday

* Per Attendee $199

 

Implementing a Robust and Compliant Change Control Program

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 705909

This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program; as well as, discuss the elements regarding successful management an effective Change Control system.

2 / Dec / 2021 - Thursday

* Per Attendee $249

 

An Update on Discharge Planning Rules and Regulations for 2022

webinar-speaker   Toni Cesta

webinar-time   60 Min

Product Id: 705120

In this program we will start by reviewing the current rules for discharge planning. Are you compliant with these rules? The newly enacted rules that are now required under the Medicare program’s conditions of participation will be reviewed as they may have a profound effect on how case management departments organize their work. Family caregivers and physicians are expected to be much more involved than they have in the past. This program will review the current rules and regulations from the Conditions of Participation (CoP) for Discharge Planning.

Be sure you know the old rules and the new rules so that your practice will be current and legal! We will review strategies for integrating these requirements into your daily practice.

6 / Dec / 2021 - Monday

* Per Attendee $199

 

Non-conforming Materials and Failure Investigations for Medical Devices

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706765

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You will learn where non-conforming material can occur and how to identify, segregate, control, and disposition non-conforming material. You will learn about when and how to conduct failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting to learn the essentials of dealing with non-conforming material and performing effective failure investigations.

6 / Dec / 2021 - Monday

* Per Attendee $249

 

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

webinar-speaker   Michael Esposito

webinar-time   90 Min

Product Id: 706104

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies. In this webinar, learn how to take a proactive approach to stay ahead of these problems.

6 / Dec / 2021 - Monday

* Per Attendee $229

 

Validation Master Plan - The Unwritten Requirements

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 705877

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

7 / Dec / 2021 - Tuesday

* Per Attendee $199

 

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

7 / Dec / 2021 - Tuesday

* Per Attendee $249

 

How To Build a Profitable Generic Pipeline Before Your Competition

webinar-speaker   Peter Wittner

webinar-time   90 Min

Product Id: 706766

We all want to have a great generic portfolio, but all our competitors also want the same thing - so how do you make sure that you get the winners to market before they do? Do you go for supergenerics, OTCs, smaller volume niches that you can exploit at higher prices - or should you stick to higher volume staples even though margins might be tight? The webinar looks at product selection and who else in the organisation you need to involve to ensure that you get there on time – is it regulatory? production planning? purchasing? strategic planners? The answer is – all of them!

7 / Dec / 2021 - Tuesday

* Per Attendee $149

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

7 / Dec / 2021 - Tuesday

* Per Attendee $229

 

Federal Oversight of Laboratory-Developed Tests in Limbo: What’s the Regulatory & Legislative Outlook for LDTs?

webinar-speaker   Dennis Weissman

webinar-time   60 Min

Product Id: 706769

This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.

8 / Dec / 2021 - Wednesday

* Per Attendee $199

 

The Family & Medical Leave Act, California Family Rights Act & Pregnancy Disability Leave: Managing Employee Leave & Possible Abuse

webinar-speaker   Diane L Dee

webinar-time   75 Min

Product Id: 706515

In the state of California, employers often struggle with abuse and fraud of protected leaves of absence as those granted by the Family & Medical Leave Act (FMLA), the California Family Rights Act (CFRA), and the Pregnancy Disability Leave Act (PDL). Employers feel uncertain how they can avoid complex leave of absence issues while protecting their own financial and business needs. The overlap between these pieces of legislation is often confusing and seemingly complicated. All three pieces of legislation provide ways in which an employer can identify an employee’s need for leave while vigilantly remaining alert to potential leave abuse.

8 / Dec / 2021 - Wednesday

* Per Attendee $199

 

Auditing the Human Resource Function

webinar-speaker   Matthew W Burr

webinar-time   60 Min

Product Id: 700648

This webinar will cover auditing human resources practices for compliance and liability to help identify and correct any areas that may not comply with applicable laws and/or do not comply with company policy.

8 / Dec / 2021 - Wednesday

* Per Attendee $159

 

Calculating the Z-Score "Bankruptcy Predictor" Model

webinar-speaker   David L Osburn

webinar-time   90 Min

Product Id: 705795

This webinar will teach how to calculate the Z-score and “correctly” interpret it based on a straight-forward scale. Five-step “key ratio analysis ” plan (liquidity, activity, leverage, operating performance, and cash flow analysis) will be displayed and tied into the comprehensive calculation of the Z-score. The session will conclude with a review of using sophisticated software such as Moody’s Lending Cloud to calculate both the Z-score and key ratios.

8 / Dec / 2021 - Wednesday

* Per Attendee $199

 

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 705164

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Recording Available

* Per Attendee $299

 

MS Excel: Advanced Pivot Tables for Superior Data Analytics

webinar-speaker   Joe Weil

webinar-time   90 Min

Product Id: 705379

Pivot Tables are one of the most powerful tools in Excel’s arsenal of data analytics. With just a few clicks, and no complicated formulas or macros, you can quickly and easily build incredibly informative reports, charts and dashboards. In this webinar, you’ll learn Pivot Table techniques that will instantly filter, summarize and analyze huge amounts of raw data. You will learn to use advanced Pivot Table techniques to rapidly produce critical information that will highlight the algorithms and trends buried in reams of data.

Recording Available

* Per Attendee $229

 

How to Conduct a Human Factors / Usability Validation

webinar-speaker   Jose Mora

webinar-time   60 Min

Product Id: 706764

In this webinar, you will learn why the FDA requires several validation participants from each “distinct user population”. Learn why the FDA requires many validation participants from each "different user demographic" in this webinar. We'll go over how to determine which tests to run and which studies to finish before the actual validation test.

Recording Available

* Per Attendee $299

 

Understanding Environmental Social and Governance (ESG) and its Compliance

webinar-speaker   Stanley Epstein

webinar-time   120 Min

Product Id: 706763

Environmental, Social, and Governance (ESG) has gained increasing attention over the past few years. Today many institutional investors will only invest in those companies that provide ESG performance reporting. ESG provides a set of standards for a company’s operations that today’s socially conscious investors use to screen potential investments in terms of how a company treats the environment, manages social issues (relationships with employees, suppliers, customers, and the communities where it operates), and deals with governance issues.

Recording Available

* Per Attendee $299

 

 

 

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