FLSA White Collar Exemptions
Patrick A Haggerty
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.
Zero-Injury Workplace Culture vs. Safety Culture
Joe Keenan
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.
Acceptance Sampling Plans for Process Validation and Production Lot Monitoring
Steven Wachs
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.
Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences
Charles H Paul
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.
The 510(k) Mod Program, Breakthrough Technologies, and STeP
John E Lincoln
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.
The Evolving Landscape for Management of Third Party Service Providers
Daniel Clark
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.
US FDA Requirements for Medical Products Labeling / UDI
John E Lincoln
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.
How to Address ISO's New Climate Change Requirements
William Levinson
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.
The GLPs and Analytical Test Methods Validation
John E Lincoln
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
Medical Devices Periodic Safety Update Report (PSUR)
John E Lincoln
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.
Power BI - Data Cleaning and Transformation: From Raw and Poor to Report-Ready
Mike Thomas
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.
Power BI - DAX Essentials: Unlock the Secrets of Effective Data Analysis!
Mike Thomas
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.
Wage Payment Irregularities/ Dealing with Disruptions in the Payroll Process
Patrick A Haggerty
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.
Understanding the new International and FDA accepted Software Development Standard IEC 62304
Dennis Moore
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.
Change is Inevitable, Employee Acceptance is Not: Managing the Impact of Organizational Change on Employees
Maure Ann Metzger
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.
Increased Tariffs and Sanctions against China: How to Mitigate Your Exposure and be Compliant
Douglas Cohen
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.
How to Globally Register a Medical Device?
Frank Stein
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. .
Facilities Management Training Course
Kelly Thomas
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.
The Summary of Safety and Clinical Performance (SSCP)
Frank Stein
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.
De-Identification of PHI under HIPAA - Follow the Guidance to Avoid Penalties
Jim Sheldon-Dean
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.