WEBINARS

 

Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

webinar-speaker   Nicole Tesar

webinar-time   60 Min

Product Id: 704534

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

Recording Available

 

AML, SOX and Licensing Controls Failures - Detection, Prevention and Risk Mitigation Strategies

webinar-speaker   Jim George

webinar-time   60 Min

Product Id: 704527

This webinar will discuss the common AML, SOX and Licensing control failures and how to detect and prevent them. The instructor will discuss the legal impact of non-compliance on banks and financial institutions, red flags and how to strengthen your internal controls to mitigate risk.

Recording Available

 

New OSC / ICE Guidelines on Internal I-9 Audits Concerning I-9 Errors and How to Correct the Errors

webinar-speaker   Bruce Buchanan

webinar-time   90 Min

Product Id: 703847

This webinar training will discuss common I-9 violations, the recent guidance for ICE and OSC internal I-9 audits and new methods offered to correct errors. The instructor will also discuss the ever-expanding actions by the Office of Special Counsel (OSC) for citizenship and national origin discrimination.

Recording Available

* Per Attendee $249

 

Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

webinar-speaker   Sunil Gupta

webinar-time   70 Min

Product Id: 704539

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

Recording Available

 

Worksheets that Capture SOP Details and Are Compliant

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 704532

This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.

Recording Available

 

CAPA Investigations - Tools for a Compliant and Effective Investigation Process

webinar-speaker   Carlos Rodriguez Garcia

webinar-time   60 Min

Product Id: 704039

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

Recording Available

* Per Attendee $229

 

Family Care and Medical Leave in California - Part II

webinar-speaker   Jacquiline M Wagner

webinar-time   90 Min

Product Id: 704508

This series of training programs on Family Care and Medical Leave in California will examine compensation while on leave, continuation of benefits while on leave, employer’s prohibited actions under the CFRA, employee’s return to work policies, and more.

Recording Available

* Per Attendee $199

 

Customs Single Window: Are You in Compliance?

webinar-speaker   Grant Smith

webinar-time   60 Min

Product Id: 704261

This training program will offer attendees an understanding of single window requirements. It will also discuss documentation requirements (electronic vs. paper) and help determine software requirements.

Recording Available

 

Document Retention: Don’t be Overwhelmed by Your Record Management Program

webinar-speaker   Cathleen M. Hampton

webinar-time   90 Min

Product Id: 704525

This training program will discuss tips for business records retention practices that both strengthen your process and standardize your records management program. The instructor with discuss why effective and reliable records management must be part of your compliance program. The course will also cover key elements of security assessment of your plan, how to plan for worst case scenarios and developing records retention schedules.

Recording Available

* Per Attendee $149

 

Cuba Sanctions: All You Need To Know

webinar-speaker   Jennifer Diaz

webinar-time   60 Min

Product Id: 704513

In this training program, attendees will learn from an established customs and international trade law expert about recent developments regarding U.S. laws and regulations addressing the expansion of trade, commerce and business opportunities in Cuba.

Recording Available

* Per Attendee $149

 

E-Compliance: Online Privacy, Harassment and Identity Theft in the Digital Age

webinar-speaker   Joseph Rosner

webinar-time   60 Min

Product Id: 704524

This webinar will discuss the bane of new technology and social media in regards to employers’ and employees’ privacy. The instructor will discuss e-compliances that employers need to adhere to avoid privacy suits. He will also cover the risks of information breach and defamation claims from electronic employee postings. Participants will know how to deal with online privacy and harassment claims and ways and limits of disciplining employees’ online presence. The course will also examine how to legally use Internet postings, profiles and other content in hiring decisions.

Recording Available

 

Discussion of Revisions Contained in ISO 13485:2016

webinar-speaker   Edward Kimmelman

webinar-time   90 Min

Product Id: 704506

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

Recording Available

* Per Attendee $169

 

Harassment and Bullying: A Sepsis in Healthcare and Detriment to Patient and Staff Safety

webinar-speaker   Dr. Susan Strauss

webinar-time   120 Min

Product Id: 704522

Harassment and bullying have become common place in America’s workplaces and particularly in healthcare. As an employer/manager you have the responsibility to both prevent and intervene any abusive conduct and as health professionals to provide quality patient care. This webinar will discuss the two forms of misconduct, what to do when subjected to the harassment or a witness of abusive conduct and how to formulate and implement harassment policy to prevent misconduct.

Recording Available

 

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

webinar-speaker   Norma Skolnik

webinar-time   4 hrs

Product Id: 704530

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

Recording Available

 

Mastering Customs Classification Under the Harmonized Tariff Schedule

webinar-speaker   Chris Pey

webinar-time   60 Min

Product Id: 704293

This training program will instruct attendees on clearly classifying products. It will discuss how best to create lasting compliance procedures which will ensure continued classification success. Attendees will also master legal classification concepts which apply to each classification exercise.

Recording Available

* Per Attendee $149

 

Emerging Issues in Food Safety - Locally, Nationally and Globally

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 704518

This training program will focus on understanding and accepting our respective responsibilities to help ensure that our food supply is safe by pursuing a food safety culture locally, nationally and globally.

Recording Available

 

Logistics and Physical Distribution

webinar-speaker   Iliyana Hristev

webinar-time   90 Min

Product Id: 704515

For all companies dealing with any type of import or export practices, this training program will provide an introduction to logistics and physical distribution, best practices for proper packaging of goods for export, and detailed information on marine cargo insurance.

Recording Available

 

Applying ISO 27001 to ERM Risk

webinar-speaker   Michael C Redmond

webinar-time   60 Min

Product Id: 704470

This ERM training program will discuss how today’s enterprise risk evaluation and control and impact analysis include identifying enterprise threats, which can truly lead not only to a disruption but also to the destruction of an enterprise.

Recording Available

 

Pre-Demolition Engineering Survey

webinar-speaker   Jon J. Pina

webinar-time   60 Min

Product Id: 702203

This webinar 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.

Recording Available

* Per Attendee $149

 

Wage and Hour Audits

webinar-speaker   Cathleen M. Hampton

webinar-time   90 Min

Product Id: 704500

Due to pressure from political influences, the need for increased tax revenues, and possibly due to concerns over illegal immigration, the U.S. Government has stepped up enforcement activities of various targeted industries, including the hotel and hospitality industry. The Wage and Hour Division (WHD) of the U.S. Department of Labor has the authority to conduct investigations in a particular industry or locality, especially when there are indications of widespread violations. The training program will focus on the importance of a wage and hour audit and discuss the framework for conducting an effective wage and hour audit.

Recording Available

 

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