Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring
Steven Grossman
90 Min
Product Id: 705023
This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.
How to Implement a Workplace Diversity and Inclusion Program
Catherine Mattice Zundel
90 Min
Product Id: 705017
A common workplace discussion often centers around diversity and inclusion and why it should be celebrated. This training program will discuss creating a strategic plan for diversity and inclusion. It will detail building an audit plan and auditing your HR department in order to determine opportunities for improvement.
Project Risk Management
Mario Mosse
90 Min
Product Id: 705015
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
Metrics and Dashboards for Quality and Compliance
Susanne Manz
90 Min
Product Id: 703928
This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data.
How to Manage Reputational Risk
Mario Mosse
90 Min
Product Id: 705012
Reputation risk is the risk of loss resulting from damages to a firm's reputation, in lost revenue; increased operating, capital or regulatory costs; or destruction of shareholder value, due to an adverse or potentially criminal event even if the company is not found guilty. This training program will explore the hidden danger behind reputational risk that can pose a threat to the survival of the biggest and best-run companies, often wiping out millions or billions of dollars in market capitalization or future revenues and occasionally resulting in a change at the uppermost levels of management.
The Overall Annual Compliance Review - Latest Advisers Act
Lisa Marsden
60 Min
Product Id: 705016
This webinar will focus on compliance requirements to prevent violations of the Advisers Act. The training program will also discuss how to design your firm’s annual review and effectively manage the review process.
What are ACH Payments, How Do They Work and What Does That Mean - Essentials of ACH Payments
Donna K Olheiser
90 Min
Product Id: 704281
This training program will help attendees identify what is the ACH network and examples of ACH electronic payments. It will list the five basic participants in each electronic ACH transaction and describe the settlement process and the difference between a debit and a credit ACH transaction.
Cyber Security Risk Assessment
Michael C Redmond
60 Min
Product Id: 704523
This training program will examine strategic planning to prepare and review your cyber and information security risks, cyber risks and impact analysis, IT outsourcing, and other underlying risks. The program will help attendees identify, analyze and document the events and environmental surroundings that can adversely affect an organization.
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Henry Urbach
90 Min
Product Id: 703058
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
Effective Deviation Investigators Under GMP
David L Chesney
120 Min
Product Id: 704974
This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
Microsoft Excel Reintroduced: Charts, Graphs, Forms, Reporting and More
David H Ringstrom
90 Min
Product Id: 704836
This training program will detail applying new charting capabilities in Excel 2013 and later, define how to save time by copying chart formatting between charts, and list ways to simplify chart-related tasks. It will also enumerate how to enliven Excel charts with clip art.
Navigating the variations in state food regulatory structure
Darin Detwiler
90 Min
Product Id: 705006
This course is designed to bring food industry leaders up to speed with the latest research in states’ food regulatory characteristics. The goal is to enable industry leaders to better understand and navigate through the state-by-state nuances.
Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget
Christopher R DeVany
90 Min
Product Id: 705013
This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.
Excel Tools for HR and Payroll Function: Featuring Date/Time Formulas, Tables, and Much More
Joe Weil
100 Min
Product Id: 705005
This Excel training program will cover a wide range of Excel functions to help simplify the task of managing and maintaining employee data. From conditional formatting to highlight HR required information to an overview of Pivot Tables, HR Dashboards, and HR KPIs, this webinar will provide essential how-to practices for HR personnel, accountants, and administrative or supervisory personnel.
Compliance with the New ICH GCP revised 2 Guidelines
Laura Brown
60 Min
Product Id: 704989
This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Charity Ogunsanya
90 Min
Product Id: 705008
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.
The 21 Elements of a 510(k)
John E Lincoln
90 Min
Product Id: 702323
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product requirements and documentation necessary to file a 510(k). The 510(k), in any of its three allowable formats, with up to 21 required elements. A brief discussion of how to address device changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on 510(k) Device Modifications: Deciding When to submit a 510(k) for a Change to an Existing Device, to provide tools to document such decisions.
Detailing Transportation Fringe Benefits
Vicki M. Lambert
90 Min
Product Id: 705003
This training program will discuss the taxation of different types of fringe benefits related to transportation including the personal use of a company car, proper accounting and taxation of auto allowances, personal use of a company aircraft, and the IRS 132 fringe benefits such as parking and mass transit passes.
The Finance of HR: Disclosure of the Human Capital Metrics to Investors
Ronald Adler
90 Min
Product Id: 704996
This webinar training will discuss the use of human capital metrics as a core competency, review the role HR metrics play in helping the organization make critical business decisions, describe the calculation of employment practices liability risk exposure, and provide a listing of some of the more widely used HR metrics.
Using the ISP98 Model Forms for Standby Letters of Credit
Buddy Baker
90 Min
Product Id: 702830
This training on Letters of Credit will walk you through the ISP98 Model Forms, explain variations and show how you can adapt them to structure standby letters of credit that comply with the provisions of the ISP98.