WEBINARS

 

Compliance Training Webinars for Regulated Industries

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FLSA White Collar Exemptions

webinar-speaker   Patrick A Haggerty

webinar-time   90 Min

Product Id: 706792

This session will review the current Department of Labor regulations as they apply to the white collar exemptions to the minimum wage and overtime requirement of the Fair Labor Standards Act (FLSA). The tests for exemption are the salary basis test, minimum salary requirement, and the duties tests. These tests have changed over the years and are complex and can be confusing. In addition, there are strict record keeping requirements and salary integrity requirements to prevent disqualification of the exemption. The webinar will also describe proposed changes to the rules and how employers can prepare for the changes.

Recording Available

 

Zero-Injury Workplace Culture vs. Safety Culture

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 704986

Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.

Recording Available

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 704315

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

Recording Available

 

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

webinar-speaker   Charles H Paul

webinar-time   90 Min

Product Id: 706939

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

Recording Available

 

The 510(k) Mod Program, Breakthrough Technologies, and STeP

webinar-speaker   John E Lincoln

webinar-time   90 min

Product Id: 706976

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

Recording Available

* Per Attendee $249

 

The Evolving Landscape for Management of Third Party Service Providers

webinar-speaker   Daniel Clark

webinar-time   60 Min

Product Id: 706980

Third Party Risk Management is all about managing service providers. For several years, businesses have been increasing reliance on third parties. While this reliance has many upsides, there are risks that should be recognized and managed. This session highlights those risks and provides alternatives to best manage them.

Recording Available

* Per Attendee $249

 

US FDA Requirements for Medical Products Labeling / UDI

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706969

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.

Recording Available

* Per Attendee $249

 

How to Address ISO's New Climate Change Requirements

webinar-speaker   William Levinson

webinar-time   60 Min

Product Id: 706977

New ISO standards, including ISO 9001, will include additional requirements related to climate change. These fortunately do not involve carbon neutrality goals, but do require organizations to consider climate change and also potential requirements of relevant interested parties.

Recording Available

* Per Attendee $249

 

The GLPs and Analytical Test Methods Validation

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706978

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

Recording Available

* Per Attendee $249

 

Medical Devices Periodic Safety Update Report (PSUR)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706880

PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.

Recording Available

 

Power BI - Data Cleaning and Transformation: From Raw and Poor to Report-Ready

webinar-speaker   Mike Thomas

webinar-time   60 Min

Product Id: 706962

This training is aimed at existing users of Microsoft Power BI who have mastered the basics and want to take their knowledge and learning to the next stage.

Recording Available

* Per Attendee $249

 

Power BI - DAX Essentials: Unlock the Secrets of Effective Data Analysis!

webinar-speaker   Mike Thomas

webinar-time   60 Min

Product Id: 706974

In today's data-driven world, having a strong command of Power BI is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Power BI’s reporting capabilities.

Recording Available

* Per Attendee $249

 

Wage Payment Irregularities/ Dealing with Disruptions in the Payroll Process

webinar-speaker   Patrick A Haggerty

webinar-time   90 Min

Product Id: 706901

This webinar provides overview of common problems encountered in payroll and methods for prevention, mitigation and resolution. The discussion will include when use of specific forms may be required, such as Form 941-X, Adjusted Employer's Quarterly Federal Tax Return or Claim for Refund and Form W-2C, Corrected Wage and Tax Statement. Special procedures related to fringe benefit withholding, deceased employee wages and misclassified employees will be covered.

Recording Available

 

Understanding the new International and FDA accepted Software Development Standard IEC 62304

webinar-speaker   Dennis Moore

webinar-time   60 Min

Product Id: 700318

This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.

Recording Available

* Per Attendee $299

 

Change is Inevitable, Employee Acceptance is Not: Managing the Impact of Organizational Change on Employees

webinar-speaker   Maure Ann Metzger

webinar-time   60 Min

Product Id: 706895

This webinar will help participants understand how change impacts people, and why people resist change. You will also learn five powerful strategies for minimizing resistance and increasing engagement, and how to create and sustain a culture of change in their organization. This webinar will help organizations and leaders to be more strategic and successful with change efforts. The strategies included in the webinar will also benefit the people most impacted by change.

Recording Available

 

Increased Tariffs and Sanctions against China: How to Mitigate Your Exposure and be Compliant

webinar-speaker   Douglas Cohen

webinar-time   60 Min

Product Id: 706864

This webinar will teach you how to lawfully reduce your tariff costs. Also attendees will learn how to do this without large investments while also being compliant with all Customs laws.

Recording Available

 

How to Globally Register a Medical Device?

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706890

Attend this webinar if you are faced with the task of having to register a product worldwide and need to think about the most sensible and efficient way to do so. The correct order of the countries and the provision of the documents and what the differences are between the various technical dossiers of the countries are often decisive here. .

Recording Available

* Per Attendee $249

 

Facilities Management Training Course

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706910

The purpose of this facilities management training course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.

Recording Available

 

The Summary of Safety and Clinical Performance (SSCP)

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706889

Attend this webinar to understand, what are the requirements of article 32 EU MDR 2017/745 for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). Your implementation needs smart ideas to reach the right level to pass the quality management audit and technical file audit by your notified body or authority inspection.

Recording Available

* Per Attendee $249

 

De-Identification of PHI under HIPAA - Follow the Guidance to Avoid Penalties

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 706865

This session will review guidance from the HHS Office for Civil Rights (OCR) and from the National Institute of Standards and Technology (NIST) about how to properly de-identify health information. The various needs for de-identified information will be discussed and typical questions covered in the guidance will be discussed, in order to provide a sound, defensible basis for an organization’s decisions and processes surrounding de-identification of PHI. Attendees will be able to go forward with de-identification with greater confidence, and better sharing of information will be possible.

Recording Available

 

 

 

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