
Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)
Peggy Berry
90 Min
Product Id: 704882
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.

How to Use Big Data for an AML/AB&C Compliance and Risk Mitigation
Shaun Miller
120 Min
Product Id: 704779
This webinar discuss how big data is used for AML compliance review. The instructor will explain how an unstructured data, becomes structured and is subjected to data quality review, sampling and subsequent forensic analysis. The instructor will share how this analysis influences strategic decision in terms of risk mitigation and AML Program enhancement.

USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP
Gregory Martin
90 Min
Product Id: 703521
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.

Developing and Using HR Audit Tools
Ronald Adler
90 Min
Product Id: 702329
This Webinar will discuss the development and use of HR audit tools. The session will cover critical HR audit issues reviewed including indentifying HR audit stakeholders, assessing HR audit areas, developing an HR audit plan, designing HR audit tools, and developing an HR audit scorecard.

Effective Annual U.S. FDA CGMP Training
John E Lincoln
60 Min
Product Id: 701136
This FDA Compliance training will be helped to see how to develop, maintain and improve on a compliant CGMP Employee Training Program for their particular company, product line, and culture.

Essentials of Taxing and Reporting Insurance Benefits for 2016 and Beyond
Vicki M. Lambert
90 Min
Product Id: 704870
This webinar covers the basics of handling insurances in the payroll department including reviewing the requirements under the ACA for the 2016 reporting of health insurance. The Instructor will cover how to handle health insurance plans such as HSAs or HRAs, taxing and reporting life insurance and third party sick pay. He will also explain the role payroll plays in workers’ compensation pay-outs and premium payments.

Overview of the Mexican Labeling Standards and the New Labeling Requirements
Sergio Ernesto Gutierrez
90 Min
Product Id: 704904
In this 90 minutes session, attendees will learn the Mexican labeling standard as well as and the new requirements regarding the use of Front of Pack icons and the voluntary nutritional quality seal.

Pre-Demolition Engineering Survey
Michael Aust
60 Min
Product Id: 704838
This training program will help you understand OSHA’s requirement for a pre-demolition engineering survey, including what documents to have in place, for renovation and complete demolition of buildings/structures.

Customs Valuation and Related Party Transactions - Transfer Pricing Documentation and Obligations
Raymond Sullivan
60 Min
Product Id: 704697
This training program will assist attendees in recognizing related-party valuation issues and discuss documenting the transaction for CBP purposes. It will further help attendees in identifying and documenting transactions that are subject to a transfer pricing agreement.

Trans-Pacific Partnership Agreement (TPP)
Jan Seal
60 Min
Product Id: 704799
This webinar will provide an introduction into some of the key chapters relating to customs, trade facilitation, duty reductions, and rules of origin and how they could impact your company. Learn more about calculating duty reductions or eliminations, documentation, and certification requirements.

Problem Solving using DMAIC
Mercedes Massana
60 Min
Product Id: 704807
This webinar will provide an introduction into the DMAIC problem solving process and will show how DMAIC can be utilized to ensure that any process which requires an investigation to be performed can be thoroughly addressed and well documented.

Conducting Performance Appraisals
Gail Birks
60 Min
Product Id: 704790
This training program is designed to actively engage the mid-level manager in formulating a conceptual understanding of the need and uses of the performance appraisal process. Attendees will learn a variety of performance appraisal models that cover self-awareness, self-regulation, motivation, empathy, and social skills.

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.

A Crystal Ball - Early Warning Signs of Construction Claims and Disputes
Jim Zack
90 Min
Product Id: 704708
This webinar provides a thorough discussion of many early warning signs of potential construction claims and disputes than may arise on construction projects. Each warning sign is associated with a particular type of claim or claims and the likely type of dispute if prompt action is not taken. The purpose of the webinar is to provide owners and contractors with a list of early warning signs of claims and disputes so that each can be proactive in dealing with these situations and prevent claims and disputes from disrupting the project.

HR Metrics: Weighing the Tactical and Operational Magnitude of Decision Making Strategy
Ronald Adler
90 Min
Product Id: 703908
This training program will discuss the use of HR metrics as a core competency, and review the role HR metrics play in helping the organization make critical business decisions. The webinar will describe the calculation of employment practices liability risk exposure, and provide a listing of some of the more widely used HR metrics.

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.

ISO 9001:2015 Risk Based Thinking Training
Kevin Gholston
120 Min
Product Id: 704801
With the release of ISO 9001:2015 September 23, 2015, now is the time to prepare. This 9001-2015 Risk Based Thinking training program will highlight the changes from the ISO 9001:2008 revision. A key change is the addition of risk based thinking, and the training includes group exercises to reinforce this new process.

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.