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The Fair Labor Standards Act: Wage and Hour Compliance for 2020
Diane L Dee
75 Min
Product Id: 705548
This webinar will provide a comprehensive understanding of the provisions of the FLSA. You will learn the proper calculation of overtime pay, gain an understanding of what is considered hours worked, what to do when state and federal laws differ, when employees must be compensated for training, travel time, meal breaks, and on-call status.
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FDA Inspections: Understanding the Core Elements – Part I
Vanessa Lopez
120 Min
Product Id: 706256
Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
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Developing an Import Compliance Policy & Procedures Manual
Deep SenGupta
60 Min
Product Id: 706512
An import compliance manual is a very important document for any company. It demonstrates the company’s commitment and understanding of the applicable import regulations. Further, it helps all the relevant employees understand their roles and responsibilities to create a compliance culture, minimizing the risk of unintentional import violations and avoidable import penalties.
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COVID-19: Wage and Hour Issues
Janette Levey Frisch
90 Min
Product Id: 706552
The COVID-19 pandemic has presented challenging wage and hour questions for employers. The federal Fair Labor Standards Act (FLSA)—and corresponding state wage and hour laws are not on hold during the pandemic. In addition to FLSA obligations, decisions regarding wage and hour could trigger nondiscrimination laws, health and safety laws, leave and accommodation laws, and state-specific laws. It also clarifies some common questions about how to handle pay for workers when they can’t physically come to work.
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Introduction to Root Cause Investigation for CAPA
Vanessa Lopez
60 Min
Product Id: 704409
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
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The Drug Development Process from Concept to Market
Mark Powell
60 Min
Product Id: 706288
The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.
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How to be a Strategic Leadership in 2020: Planning and Decision Making in Today's Environment
Rebecca Staton Reinstein
90 Min
Product Id: 706554
It's easy to become a victim of the "To-Do" list, crisis management, and reacting to the latest fire. Unfortunately, that approach seldom leads to sustainable success. Focus on driving your daily action through the power of your vision and mission, plan strategically, and focus on results to get the progress your organization demands. In 2020 that means staying more concerned with your team members’ wellbeing and their needs.
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Developing an Export Compliance Policy & Procedures Manual
Deep SenGupta
60 Min
Product Id: 706509
An export compliance manual is a very important document for any company. It demonstrates the company’s commitment and understanding of the applicable export regulations. Further, it helps all the relevant employees understand their roles and responsibilities to create a compliance culture, minimizing the risk of unintentional export violations and avoidable import penalties.
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Virtual Onboarding - The New Normal During A Pandemic Situation
ArLyne Diamond
60 Min
Product Id: 706551
This webinar identifies some of the problems HR and others responsible for onboarding have for trying to assess the needs of the person they have never met. You will learn what you can do to make onboarding the at home worker more successful. It will provide techniques for those you have onboarded to become more comfortable.
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Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Frank Stein
90 Min
Product Id: 706165
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
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Anticipating and Addressing Employee's Return-to-Work Concerns Post-COVID-19
Diane L Dee
90 Min
Product Id: 706550
The COVID-19 pandemic has turned everyday life upside down. Millions of Americans are now working from home. And while the current pandemic will certainly end, the transition back to “normal” life is likely to be gradual, with many predicting that the “normal” we once knew is a thing of the past and that the workplace employees return to will forever be changed. This situation presents multiple challenges for organizations looking to transition their staff back to on-site work. Whether they have been furloughed or transitioned to work remotely full time, re-onboarding needs to be well-planned and effectively communicated.
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Supplier and Service Provider Controls: FDA Expectations
Vanessa Lopez
120 Min
Product Id: 704844
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
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Preparing for a US FDA CGMP Compliance Audit Under 21 CFR 210, 211 and 820
John E Lincoln
60 Min
Product Id: 706513
Recent US FDA Inspections ("audits") indicate the "c" in CGMP is a moving target – with expectations growing upward! In this webinar, learn how to use the FDA's inspection flow charts and questions, past inspections, and key elements of the CGMPs to prepare for an FDA GMP Compliance Inspection. Recognize that past results are not an accurate of future inspection results. You will learn how to incorporate industry findings into your gap analysis and remediation plan.
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Project Management for Non-Project Managers in The Life Sciences
Charles H Paul
90 Min
Product Id: 706535
Today more than ever before the job titles that we hold are not entirely reflective of the work that we do. Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex projects. Project management requires specific knowledge of the key project facets that must be carefully managed. The interactions across divergent corporate functions, culture, language, and time zones all pose unique challenges to the new project manager.
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Filing IRS Form 1099-NEC & W-9 Update - Complying with IRS Information Reporting
Miles Hutchinson
60 Min
Product Id: 706545
For years the IRS has struggled with non-compliance by independent contractor and their tax payments. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding information reporting on taxpayers by payors – using forms 1099. For 2020 the IRS has added another form – the 1099-NEC. This time-consuming reporting obligation can be streamlined in a number of ways. Join us to learn more…
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How to Conduct High Quality Risk Assessments
Mario Mosse
90 Min
Product Id: 704994
This training program will help articulate your business objectives and define the scope of your risk assessment. It will guide attendees in identifying the most appropriate risk assessment technique and plan and facilitate a risk assessment. Further, the session will help tailor a risk matrix to enable you to rate your risks.
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Spotlight on Complaint Handling and Medical Device Reporting
Susanne Manz
90 Min
Product Id: 706099
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
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Compliance Management - Introduction; Laws and Regulations
Stanley Epstein
90 Min
Product Id: 706544
Creating a culture of compliance is an important risk management strategy. Recent corporate collapses have reflected the need for good corporate governance and an effective compliance program is an integral part of this structure. This introduction to Compliance Management provides a blueprint for compliance professionals to follow to ensure that the risk profile in his/her organization is limited by a thorough understanding of the individual regulatory environment.
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Will your food fraud vulnerability assessment pass an audit?
Karen Everstine
60 Min
Product Id: 706066
The webinar will provide you with valuable information about setting up a food fraud vulnerability assessment so that you are better prepared to meet the food fraud-related requirements of GFSI Certification Programme Owners and the economically motivated adulteration requirements of the U.S. Food Safety Modernization Act.
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FDA Design and Document Change Control
Denise Arrington
90 Min
Product Id: 706555
Learn about change control process and procedures in regulated industries. This webinar help you understand and successfully apply change control steps and best practices.