Hazardous Substance Management for Medical Devices and In-Vitro Diagnostics - Comprehensive Regulatory Support for the Supply Chain
Wilhelm Pfleger
60 Min
Product Id: 704228
This training program will offer an interpretation of the latest ruling of Reach SVHC. It will also discuss the RoHS directive – the four substances added to the restriction list in Annex II.
Defending FCPA Claims and Minimizing FCPA Exposure
H. David Kotz
60 Min
Product Id: 704556
This training program will highlight how one can effectively manage risks resulting from Foreign Corrupt Practices Act (FCPA) claims. Presented by the former Inspector General of the SEC, who served in senior-level positions in several federal agencies, the webinar will provide practical lessons on how to manage FCPA claims, devise effective compliance programs, conduct internal investigations and achieve a culture of compliance in an organization.
Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List
Robert A North
90 Min
Product Id: 704551
This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.
Get on the Energy Omnibus: After-Effects of FY2016 Omnibus Bill and the FY 2017 Budget on Tax Credits, Renewable Energy, and Distributed Generation
Tamar Cerafici
90 Min
Product Id: 704583
This training program will provide an overview of the FY 2016 Omnibus and FY 2017 Budget Request. It will explore why the Renewable Energy ITC and PTC are still important and relevant to the industry. The instructor will also elaborate the role of renewable energy in the administration’s Climate Action Plan and highlight the economic incentives that work in your industry.
10 Best Practices to Improve Your Fiscal Closing Process
Chris Doxey
90 Min
Product Id: 704580
Regardless of company size or complexity, all successful financial close processes require continuous communication, comprehensive documentation and a flexible, responsive organization. This training program will focus on 10 critical methods that you can use to dramatically improve your Record to Report (R2R) process. The R2R or Financial Closing Process is the centerpiece of the controllership function. This program will examine the process that ranges from transaction processing through internal and external reporting, and it incorporates everything from internal controls, the corporate organizational hierarchy - its people, processes, and technology.
Preparing for a UDI Implementation
Lena Cordie Bancroft
90 Min
Product Id: 704579
This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.
A Critical Review of the New Medical Cannabis Regulatory Regime in California
Erik Janus
60 Min
Product Id: 704578
This training program will examine key questions on how California’s future medical cannabis market will look like when it comes to regulation. In the next two years, multiple state agencies will be involved in filling in the blank spaces left by MMRSA. For example: What will licensure fees look like? How will “edibles” be regulated in California? In the background, a new President will be elected soon and this could influence the future of all state-based medical cannabis markets. Insight and opinion on all these issues will be provided by a regulatory expert with years of expertise in influencing state and federal decision-making and policy.
Compensation Communication: How to Create a Base Pay System That Makes Sense and Doesn't Disappoint
Gary L Markle
90 Min
Product Id: 703045
This HR compliance training explains the best practices to adopt in order to effectively communicate compensation related issues to employees. You will also learn creating a base pay system that is sensible and fair.
Seven Habits of an Effective Loan Committee
Robert D Hawkins
60 Min
Product Id: 704570
This training program will list and discuss documents required to complete the five steps in the documentation process. On completion of the program, attendees will be able to provide a broad overview of the loan documents’ provisions to borrowers and loan processing management techniques.
How to Plan for the Proposed Changes to the Fair Labor Standards Act (FLSA) - Part 1
Bob McKenzie
60 Min
Product Id: 704581
This training program will offer best practices for staying in compliance with the Fair Labor Standards Act when the proposed regulations are released while exploring the critical nature of the right communications. It will be followed-up by a 60 minutes complimentary Q&A Session(Series2)on Monday, May 9th 2016.
Exporting: A Business of Details
Iliyana Hristev
90 Min
Product Id: 704569
Beginning with the initial interest and concluding with payment, this training program will provide a handy flow-chart for consideration and guidelines of exactly how to execute a successful transaction, from conception through connection and up until collection. It also indicates options available to the exporter based on size and value of shipment, country of destination and type of buyer.
Foreign Exchange Hedging for Corporations
Jonathan Wetreich
90 Min
Product Id: 704133
In this training program, attendees will learn the types of FX hedge programs typically utilized by corporations and the hedge instruments typically used by corporate hedgers such as forwards and collars. They will also gain an understanding of the concept of view-neutral hedging.
How to Create Effective Employee Newsletters
Randall A Olson
60 Min
Product Id: 704564
This training program will help you determine if an employee newsletter is right for your company. Attendees will further learn best practices for newsletter content, design and distribution, and how to create and oversee the development and production of employee newsletters.
Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry
Igor Gorsky
2 hrs
Product Id: 704560
This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.
Biological Facility Design: Design for Compliance
Erich Bozenhardt
60 Min
Product Id: 704576
This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.
Food Defense - Is your organization safe?
Jason Teliszczak
60 Min
Product Id: 703271
This food defense webinar will detail what an organization needs to have in place in order to safely manufacture, package, and or handle food products. It will cover a broad range of production types, facilities, and the transportation of goods. This webinar will highlight key areas of the organization that need to be controlled to ensure that intentional contaminants do not enter the product by potential threats.
Risk Based Design Control
Edwin Waldbusser
60 Min
Product Id: 704548
This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.
The Materials of Trade Exception to the Hazardous Materials Regulations (HMR)
Daniel Stoehr
60 Min
Product Id: 704511
This training program will expand attendees’ knowledge of USDOT’s Hazardous Material Regulations. They will understand role and use of exceptions to the HMR and learn requirements for and limits of use of Materials of Trade exception.
HIPAA Privacy Rule, Patient Access, and Communications - New Guidance, New Issues, and New Threats to Compliance
Jim Sheldon-Dean
4 hrs
Product Id: 704472
This training program will review why all HIPAA-covered providers need to review their HIPAA compliance, policies, and procedures to see if they are prepared to be in full compliance and meet the requirements of the changes in the rules. Compliance is required and violations for willful neglect of the rules begin at $10,000.
Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice
Armin Hauk
60 Min
Product Id: 704340
This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.