
Creating a Good Design History File (DHF) for Audit Success
Mercedes Massana
60 Min
Product Id: 701978
This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.

Equipment Qualification Basics
Joy McElroy
90 Min
Product Id: 704403
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

Wire Fraud - Detection and Prevention
Rayleen M Pirnie
90 Min
Product Id: 704399
This training program will discuss common forms of wire fraud such as: account takeover (consumer, corporate, and institution internal accounts); false invoices / money mules and advance fee frauds; business email compromise; and supply chain fraud. It will also discuss wire fraud detection, fraud mitigation, and sound business practices to thwart attempts.

Cyber Risk Register: The Cornerstone for Understanding and Managing Cyber Risk
Mario Mosse
90 Min
Product Id: 704977
Information technology assets and information need to be protected against unauthorized internal or external access and cyberattacks. These attacks may result in data destruction, alteration, unavailability or breach of confidentiality. This training program will discuss how developing and maintaining a cyber risk register is a fundamental step toward inventorying, assessing and addressing cyber risks threatening your organization.

Retaliation and Whistleblower Claims | No FEAR Act, Trends and Best Practices to Avoid Litigation
Susan Fahey Desmond
90 Min
Product Id: 704903
This webinar training will discuss about the whistleblower claims and NO FEAR Act. The Instructor will discuss the types of whistleblower claims and new developments under the No FEAR Act. Participants will learn how to manage internal investigation and litigation issues.

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
Henry Urbach
60 Min
Product Id: 702964
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

OSHA Enforcement for Employers Using Temporary Workers
Michael Aust
60 Min
Product Id: 704972
This training program will address OSHA’s initiative focusing on safety and health compliance for temporary workers. It will detail OSHA’s TWI initiative for temporary workers and review OSHA’s Bulletins 1-7.

How to Pay Overtime Correctly under the Fair Labor Standards Act - Legal risk and court interpretations
Susan Fahey Desmond
90 Min
Product Id: 701874
This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.

Employee Engagement: Keeping Your Workforce Motivated to Improve Results @Workplace
Catherine Mattice Zundel
90 Min
Product Id: 704971
Employee engagement doesn’t have to be a hard to reach target. Essentially, there is a ton of research on how to increase employee engagement, and this webinar will sum it all up for you. The training session will also provide several vignettes along the way, to demonstrate how powerful the impact a focus on employee engagement can be.

Managing Construction Excavation Activities
Michael Aust
60 Min
Product Id: 704693
This training program will focus on OSHA’s Excavation Standard - Subpart P. It will analyze types of excavation hazards, control measure techniques to minimize hazards, soil analysis techniques, and protective system requirements.

How to Develop an Effective Risk Register
Mario Mosse
90 Min
Product Id: 704969
A risk register, also known as a risk log, serves as a central repository for the organization's risk information. This training program will discuss its key function, i.e., to provide management, the board, and key stakeholders with significant information on the main risks faced by the organization. The program will also delve into designing and using your own ‘fit-for-purpose’ risk register.

Structuring Physician Recruitment and Non-Physician Practitioner Support Arrangements Under the New 2016 Stark Rules
Joseph Wolfe
60 Min
Product Id: 704469
In this session, the training instructor will provide a general Stark Law overview. He will also discuss best practices for auditing existing recruitment arrangements and for implementing new NPP support arrangements under the new 2016 Stark rules.

Working With ELLA (Employment-Labor Law Audit): An HR Audit Model
Ronald Adler
90 Min
Product Id: 704968
This training program will discuss the use of Employment Labor Law Audit (ELLA®) as a core competency, review the role HR auditing plays in helping your organization make critical business decisions, and describe how ELLA® can help reduce employment practices liability risk exposure.

A Primer on OFAC/Sanctions Compliance
Joe Soniat
60 Min
Product Id: 704998
This training program will detail the purpose of OFAC screening and OFAC risk assessment. It will define a politically exposed person (PEP). Further, the webinar will also offer best practices regarding the OFAC screening process and guide attendees on how to document the process of an OFAC case review.

Employer's Continuing Obligation: Maintaining Accurate Records of Each Recordable Injury and Illness
Michael Aust
60 Min
Product Id: 704982
This OSHA training program will discuss updated recordkeeping mandates set by OSHA and emphasize the importance of OSHA's recordkeeping regulations. The webinar will further detail why a failure to record a recordable illness or injury is a continuing violation and the D.C. circuit's decision in Volks II.

Developing an Affirmative Action Plan in the Age of Inclusion-Title VII of Civil Rights ACT 1964
U Harold Levy
90 Min
Product Id: 704925
This webinar discusses how and why the demographics of country are changing and the business impact of an inclusive business environment. The instructor will explain the federal and state laws and policy that provide for equal employment opportunity and affirmative action in employment. Participants will learn how to develop a fair and equitable Affirmative Action Plan that can withstand scrutiny.

Selection and Management of Contract Vendors
Peggy Berry
90 Min
Product Id: 704884
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.

The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND
Robert J Russell
90 Min
Product Id: 702030
This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.

Planning and Managing Organizational Change: 10 Tips and Techniques
Christopher R DeVany
90 Min
Product Id: 704980
This training program will analyze the gaps that need to be addressed while implementing organizational changes. It will help attendees assess major issues involved in organizational readiness, help overcome intellectual challenges, help create effective communication plans, ensure all systems support, and finally, assess change management.

Export Control Awareness: Apply and Understand Licensing Exceptions
Matilda Vasquez
60 Min
Product Id: 704963
This training program will review changes in the Foreign Trade Regulations, Export Administration Regulations, Office of Foreign Assets Controls, and the International Traffic in Arms Regulations. It will also offer an understanding of the basics of applying for an export license through the BIS.