
Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
Henry Urbach
60 Min
Product Id: 702635
This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.

FDA Inspection Preparedness
Susan Muhr Leister
60 Min
Product Id: 704221
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

A Risk-Based Methodology to Develop and Prepare an Effective Service Level Agreement (SLA) Package to Improve Service and Security Quality
Javier Kuong
90 Min
Product Id: 703999
This training program will illustrate a structured methodology to develop effective service level agreements based on a top-down, risk-based approach, summarized in a matrix that documents the whole development process for specific SLAs that respond to business objectives.

The HIPAA Audit Program for 2016 - New Focus, New Process
Jim Sheldon-Dean
150 Min
Product Id: 704434
This training program will discuss the HIPAA audit program and how it works, and discuss the areas that caused the most issues in the 2012 audits. It will explore issues and entities that presented the most challenges, and highlight where entities need to improve their compliance the most, and also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in 2016.

4 P’s of ITAR - Policies, Provisions, Procedures & Penalties
Suzanne Richer
60 Min
Product Id: 704343
This training program will offer an overview of the International Traffic in Arms Regulations (ITAR) Part 126 – General Policies and Provisions, Part 128 – Administrative Procedures.

Managing Through a Product Recall - Process and Procedures
Richard Maksimoski
60 Min
Product Id: 704325
Attendees will leave this training session with more confidence, vision, and productivity. The confidence is knowing that you have a process that is developed prior to the actual event (if ever needed) and a decision tree is developed in time of stability rather than one of high emotion. The ability to establish the necessary processes will allow you to have confidence that your company will not be operating in panic mode.

Marketing for Most of Us Today
Barney Kramer
90 Min
Product Id: 704287
This training program will focus on current marketing avenues such as outbound and inbound marketing, social media and its reach with consumers, content marketing and more. It will focus on the basics of marketing principles and guide attendees in developing target markets and segments for subsets of your strategic plan.

Complimentary Webinar - Best Practices for Teaching Technical Subjects
David A Casavant
Product Id: 704427
This 90 minute webinar is designed for presenters, new trainers, seasoned veterans or anyone responsible for presentations. The speaker will share cutting edge ideas on how to make a presentation that will easily explain difficult concepts and get the right message across to your audience.

NAFTA Qualification Process for USA, Mexico and Canada
Randi Waltuck Barnett
90 Min
Product Id: 704424
This webinar explains the US Customs Modernization Act (the Mod Act) and NAFTA. Participants will understand the regulations and guidelines of NAFTA for Imports, including auditing Certificates of Origin for facial validity, NAFTA for Exports, including Tariff Shift & Regional Value Content ,NAFTA Record Keeping & Risks & Penalties.

FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
Angela Dunston
90 Min
Product Id: 704431
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

HIPAA Requirements for Safeguarding Protected Health Information
Jay Hodes
60 Min
Product Id: 703976
This HIPAA requirements and compliance training program will discuss the HIPAA Security and Privacy Rules and detail the entire HIPAA compliance process. The course will also discuss the role of a business associate and the penalties and fines for non-compliance and best practices to avoid them.

5-Hour Virtual Seminar: P2P Standards of Internal Controls - Preapproved by the American Purchasing Society
Chris Doxey
5 hrs
Product Id: 704195
This two-part five-hour certificate program focuses on internal controls leading practices and standards for the Procure to Pay (P2P) process. Attendees will learn about internal controls best practices by focusing on the Internal Controls Questionnaires (ICQ) for each component of the P2P process. Participants in this program will obtain a certificate in Procure to Pay (P2P) Standards of Internal Controls from the American Purchasing Society (APS).

New Part 11 Guidance for Clinical Trials: What This Means for You
Sarah Fowler Dixon
60 Min
Product Id: 702990
This training on 21 CFR Part 11 guidance for clinical trials will explain the new 21 CFR Part 11 regulations for electronic records and what that means for your organization and the clincial studies you conduct.

Customer Service Begins in HR
Mary Gormandy White
60 Min
Product Id: 704411
This training program, participants will learn how and why customer service really begins with the HR function, and gain actionable knowledge that they can use to improve their ability to provide effective customer service to their organization’s very important internal customers. Speaker will discuss how we can set the right work culture and ethics through internal training of new and existing employee to deliver highest quality of customer service.

HR Analytics: Forecasting and Planning Your HRM Better
Tom Palladino
120 Min
Product Id: 704265
This training program will discuss the difference between analytics and metrics, how analytics can be used to significantly help the business, case studies to demonstrate real life projects, how to develop an analytics model, and more.

The Core of Program Management Across Sectors
Samir Penkar
60 Min
Product Id: 704402
This training program will lay emphasis on industry trends shaping the program management world. Course participants will learn the top three core program management concepts needed to shape and update your programs.

Developing and Implementing an Export Management Control Program
Randi Waltuck Barnett
60 Min
Product Id: 704400
This training program will offer attendees an understanding of the legal framework for US commercial exports and discuss how you can leverage your existing quality system (QS) for your exports. Participants will also learn to identify areas where their existing ERP can support ECMP requirements.

Protect Your Company: Why HR Audits are Important and Some Tips on How to do them
Vicki Amsinger
60 Min
Product Id: 703446
This webinar will explain the importance of HR audit. Attendees will learn the best practices that can reduce the liability and risks associated with HR management.

I-9 Form Immigration Compliance - Is Your Company Ready for ICE?
Bruce Buchanan
60 Min
Product Id: 703930
This training program on I-9 form immigration compliance will discuss an organization’s preparedness for ICE inspections. It will detail compliance requirements and penalties for non-compliance along with course of action on receipt of Notice of Inspection from ICE.

3-Hour Virtual Training: Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment
Marna Steuart
180 Min
Product Id: 704386
This training program will detail key components of a risk assessment and management program, and include a fraud risk assessment discussion. Other training points in the program include analyzing the methodology for successful risk assessment process, understanding the steps involved in the risk assessment process, and fraud risk assessment.