
Tips on Dealing with Securities Regulatory Authorities - Audits, Etc.
Jack Bensimon
60 Min
Product Id: 706261
This webinar will discuss ways to effectively and efficiently deal with regulators, whether it be from an audit or other interaction. Regulators speak their own language and understanding this is imperative to building relationships and passing regulatory scrutiny.

Enhancing Audit Advisory Practices
Daniel Clark
60 Min
Product Id: 706260
Today’s Internal Audit groups are expected to do more than just assurance work. They are required to provide management with industry best practices, trends in risk management and perform advisory reviews of emerging and topical areas. This webinar introduces a new tool that helps internal audit groups move from the traditional role of assurance provider to the more valuable trusted advisor.

Employment Laws and Regulations for 2020: Employers Should Prepare for Regulations that will impact them - Ignorance is No Excuse for Non-Compliance
Margie Pacheco Faulk
90 Min
Product Id: 706277
Attend this webinar to learn about workplace laws that will impact employers. Managing these laws will determine how Employers will survive strict fines and penalties and create a robust risk management strategy for their workplace.

How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability
Dr. Susan Strauss
120 Min
Product Id: 704415
This webinar undertakes to explain the process of internal harassment and bullying investigation. Participants will learn how to handle harassment complaints and conduct the investigation to determine facts and minimize liability by analysing evidences, drawing conclusions, writing the formal report outlining the investigation and taking corrective actions where necessary.

What To Expect From FDA’s New Approach to Regulate Medical Software
Dennis Weissman
60 Min
Product Id: 706085
The FDA’s emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers. So, it is critically important for companies throughout the life sciences and healthcare industries that utilize software in its products to understand the important challenges and opportunities presented by this major policy shift. This webinar will provide understanding.

Webinar Series: eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Peggy Berry
8.5 hrs
Product Id: 706320
This four day webinar series (each day 3 hrs) will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.

The Utilization Management Committee: Strategies for coordinating Medical Practice with Hospital Goals
Bernadette Benta
60 Min
Product Id: 706303
This webinar will provide a detailed overview of proven strategies that maybe employed to ensure that hospital goals are aligned with medical practice. This is key to delivering high-quality coordinated care to produce Quality Patient Outcomes and Cost-Effectiveness. There will be special focus on the Utilization Review Committee (URC) as a CoP.

Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit
George Yanulis
90 Min
Product Id: 706295
Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.

Medical Device Registration Requirements in Saudi Arabia and MEA
John Riggi
60 Min
Product Id: 706291
This webinar will discuss the basics of product registration in Saudi Arabia and MEA such as Registration Timelines, documentation requirements and governmental processes.

Operational Risk Scenario Analysis
Mario Mosse
90 Min
Product Id: 703751
Scenario analysis complements the risk assessment process, which often overlooks material events that only happen infrequently, such as natural disasters, acts of terrorism, and data breaches. This webinar will highlight the importance of scenario analysis, its objectives and expected benefits, and the ideal methodology for quantifying and reporting operational risk scenarios.

ISO 22000 vs GFSI (SQF, BRC, IFS, and FSSC 22000): Meeting key Requirements
Ben Marandi
90 Min
Product Id: 706278
Attend this webinar to understand how to select the right standard for your organization. Due to complex challenges, many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes, which include SQF, BRC, IFS, FSSC, GLOBALG.A.P. and BAP and CanadaGAP.

A New Role for Project Controls Professionals on Dispute Boards
Jim Zack
90 Min
Product Id: 706255
Attend this webinar to learn how project controls professionals can add value to the DRB process and help contribute to dispute resolution on many projects as members of Dispute Resolution Boards.

4-hr Virtual Seminar: Financial Controller Job - Roles, Responsibilities and Skills for Success
Miles Hutchinson
4 hrs
Product Id: 704024
This training program will guide attendees on what it takes to become a successful controller. The program will help identify the primary functions and responsibilities of the controller and how your role will change as you move into this position.

Recognizing and Responding to "Red Flags" in Clinical Operations
Peggy Berry
90 Min
Product Id: 706094
Sponsors need to comply with various legal requirements for drug product development. These include communications with Federal and State Regulatory agencies. The post-marketing requirements include more functional areas of the company such as sales and marketing, medical affairs, and external spokespersons.

Automating Assays for Clinical Diagnostics
Todd Graham
60 Min
Product Id: 703268
This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Beyond 'Illegal' Interview Questions: What Hiring Managers Need to Know About Protected Characteristics
Mary Gormandy White
60 Min
Product Id: 706253
This webinar focuses on providing hiring managers and others who interview candidates for employment with a comprehensive overview of what they need to know about protected characteristics to screen applicants, conduct interviews and make hiring decisions in a manner that is compliant with all United States equal employment opportunity (EEO) laws and regulations.

Equal Employment Opportunity Compliance for Supervisors and Managers: Creating and Preserving a Legal and Respectful Workplace
Ronald Adler
60 Min
Product Id: 702182
This Equal Employment Opportunity (EEO) compliance training for managers and supervisors will cover key employment discriminations and regulations, You will also learn risks associated with discrimination, EEO related metrics and how you can protect your organization from significant liabilities by being in compliance with EEO laws.

What Is An ISF, Why Is It Needed?
Charles Jacque
60 Min
Product Id: 706254
This webinar will teach the individual about the functioning use and necessity of the ISF to meet compliance rules and regulations that have been enhanced to meet our ever-changing security needs for our imports.

Mexico Procedures and Documentation
Jan Seal
90 Min
Product Id: 704260
This export requirement training will explain the current procedures and documentation requirements for U.S. exports to Mexico and for imports into Mexico, how to avoid delays, cross-border trucking, mandatory labeling requirements, Mexico's Harmonized Tariff Schedule, and recordkeeping requirements.

How to Prepare for an FDA Inspection?
Loren Gelber
90 Min
Product Id: 705878
In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.