Creating the ISO 14971:2007: Developing the Risk Management File
Daniel O Leary
90 Min
Product Id: 704855
This presentation gives you the essential information you need to write a successful plan. Many companies try to implement Risk Management using an inadequate Risk Management Plan. They often leave out required items or add additional, but unnecessary information. The Risk Management Plan is key to an efficacious project to ensure your device is safe and meets the regulatory requirements.
Learning Design Controls through review of FDA 483 Observations
Mercedes Massana
75 Min
Product Id: 704805
This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.
ADA Accessibility - Is Your Property in Compliance?
Richard Vivenzio
90 Min
Product Id: 704888
The ADA is both complicated and controversial. This webinar will explain the ADA litigation trends and provide tips on how to avoid ADA complaints and lawsuits. Participants will learn about the ADA requirements for new and existing building projects and how to comply with them.
3-hr Virtual Seminar - Export Control Compliance: Creating and Self-Assessing Your Export Control Program(ECP) to Sanctioned Countries
Suzanne Bullitt
3 hrs
Product Id: 704710
This webcast will focus on the fundaments of U.S. export controls, establishing a framework for your export compliance program (ECP) and testing mechanisms to ensure success moving forward. The Instructor will discuss the regulatory standards required under the Export Administration Regulations (EAR) that any ECP needs to comply with. Participants will learn to create an effective ECP which is planned, clear and provide direction and guidance to those affected by the program.
How to Increase your Revenue by Billing for Durable Medical Equipment and Stay Legally Compliant
Gregory J Simms
60 Min
Product Id: 704883
This training program will discuss best revenue opportunities and how to get a Medicare DME PTAN number. Attendees will also learn to build a solid business process to prevent and attack audits, learn in-network and out-of-network capabilities and gain a better understanding of the Anti-Kickback Statue and Stark Act.
Employee Orientation: Job Enlargement, Enrichment and Enhancement
Meloney Sallie Dosunmu
90 Min
Product Id: 704895
This webinar training discusses the success factors for implementing effective job design. The instructor helps in identifying the readiness of employee, the orientation needs and suitability. Participants will learn about the appropriate circumstances and best methods to implement and evaluate the effectiveness of job enhancement, job enrichment or job enlargement.
Biological Indicators for Sterilization Performance Qualification
Aaron Mertens
90 Min
Product Id: 704879
This webinar will focus on biological indicator usage for sterilization performance qualification in the pharmaceutical and biotech industry. Biological indicator preparation, including population and D-value resistance determination, is presented in depth. Understanding these details is critical to successfully choose a biological indicator and qualify a sterilization process.
Navigating the Maze of ADA and FMLA Compliance: The Interplay Between the Laws - Part 4
Cathleen M. Hampton
120 Min
Product Id: 704833
As many have noted, the interaction of the Family and Medical Leave Act (FMLA), Americans with Disabilities Act (ADA), and workers' compensation laws is known by many employers to be the Bermuda Triangle of employment law. To help fill in the gaps, this training session will analyze the statutes, regulations, and guidance to answer the most frequently asked questions about these laws.
Regulation of Natural Health Products in Canada
James Russell
90 Min
Product Id: 704044
This training program will discuss regulations that impact Natural Health Products in Canada. It will detail how to verify the products’ compliance with published regulations. It will also detail requirements for registration, labeling and acceptable marketing claims.
Objections to Agile and what you can do about them?
Brian Shoemaker,Nancy Van Schooenderwoert
60 Min
Product Id: 704872
This webinar will review the classic objections to Agile practices and explain how to overcome them. We will discuss real-world examples of medical device companies currently employing Agile approaches and understand how you or your company can gain similar benefits.
Mission Possible Series: Reducing Your Compensable Claims by 50% Within 2 Years - Part 2
Michael Aust
60 Min
Product Id: 704752
This training program in the series will explain what it means to establish a safety culture within the workforce. It will also identify the key steps in an effective workers’ compensation management program and discuss roles and responsibilities of each step of the safety maturity curve. Attendees will learn the benefits of sustaining an effective worker’s compensation management program in the workplace.
Performance Metrics: Measuring Bank Management's Effectiveness
David L Osburn
60 Min
Product Id: 704832
This training session will discuss how to measure the effectiveness of bank management from a technical and employee perspective. The webinar will also cover department policies and procedures, increasing customer satisfaction, and improving employee morale. Additionally, the webinar will review individual and team evaluations and measuring bank financial performance. The webinar concepts will be illustrated through case studies.
US Export Documentation & US Export Record-Keeping: A Deep Dive
Suzanne Bullitt
60 Min
Product Id: 704042
This training program will help attendees ensure their business is meeting the necessary retention requirements under Part 762 of the EAR. Export documentation is a tedious but necessary process that all exporters must pay close attention to, as documentation requirements vary considerably by country, commodity, and situation. Although exporters must fill out and submit many different forms for each international shipment, most require similar data elements and can be duplicated precisely from one document to the next.
Steam Sterilization Microbiology and Autoclave Performance Qualification
Aaron Mertens
90 Min
Product Id: 704850
This webinar will discuss the regulatory and GMP requirements for steam sterilization and the mechanism as it relates to bacterial cells and endospores. The training will cover autoclave performance qualification studies and the tools to be used.
Navigating the Maze of ADA and FMLA Compliance: Detour to Workers' Compensation - Part 3 of 4
Cathleen M. Hampton
120 Min
Product Id: 704825
When administering the ADA and FMLA it is important to consider the complexity of workers’ compensation in the mix. In this, the third training program in the series, the webinar instructor will discuss the EEOC’s general guidance regarding the term “disability” as it relates to an occupational injury.
And the Answer is...Researching Payroll Questions
Vicki M. Lambert
90 Min
Product Id: 704822
This training program will focus on payroll research and how to find the information necessary to answer complex questions that arise in the payroll department. By using actual website examples, the webinar will examine the basics of researching the IRS and Department of Labor websites and the intricacies of using the state statutes provided on the legislative websites.
FDA Regulation, 3D Printing and Medical Devices
Rachelle D Souza
75 Min
Product Id: 704846
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.
Sexual Harassment in the Workplace
Gail Birks
60 Min
Product Id: 704771
This training program is designed to heighten participant’s knowledge of the working definition of sexual harassment. It will also focus on other employment laws, and discuss state and federal laws on sexual harassment.
Welding, Cutting, and Brazing Safety: Am I Safe?
Michael Aust
60 Min
Product Id: 704818
This training program will focus on OSHA regulations for welding, cutting and brazing safety, identifying essential types of PPE for use, engineering methods to improve worker safety, and identifying the HI&RAA (Hazard Identification & Risk Assessment Activity) systematic process.
Navigating the Maze of ADA and FMLA Compliance Series: The ADA Made Simple - Part 2 of 4
Cathleen M. Hampton
120 Min
Product Id: 704814
The ADA and FMLA often interact and if organizational managers aren’t sure how to navigate these complex regulations, including the gray areas, your company may be at risk. In this second part training of the ADA and FMLA compliance series, we will review the fundamental aspects of The American with Disabilities Act (ADA) as it relates to employment, including best practices for accommodating employees with disabilities.







