
How to Survive a DEA Inspection Series - DEA and Veterinary Medicine
Carlos M Aquino
60 Min
Product Id: 704563
This training program is tailored for practitioners treating pain. It will provide you with a better understanding of a DEA inspection and the records needed in the event of an inquiry by DEA or any state regulatory agency. Participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II through V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan.

Monitoring for the FSMA Proposed Rule on Intentional Contamination
Ned Mitenius
60 Min
Product Id: 704451
The program will discuss the practical development of an adequate monitoring program optimized to fit the Intentional Adulteration Rule. Attendees will learn the difference between monitoring, verification and validation. The program will review the existing Food Defense Plan Builder tool including its limitations and some possible changes. In the absence of a provided tool, the program participants will be shown how to create an effective monitoring program, and the documentation required to support it.

What to Expect When Your Employee Is Expecting: Navigating Pregnancy-Related Issues in California Workplaces
Jacquiline M Wagner
60 Min
Product Id: 704536
This webinar training course will assist California employers navigate the sometimes turbulent waters of successfully addressing and managing the issues afoot when an employee is expecting. The Instructor will share practical methods of evaluating pregnancy accommodation request, ensuring a pregnant employee receives entitled leave and tips for ensuring a smooth return-to-work.

HR/Benefits Outsourcing - Return on Investment (ROI)
Rob J Thurston
90 Min
Product Id: 704535
This webinar training will discuss how to identify key areas of HR/ benefit that can be outsourced and to evaluate and find quality outsourcing options. The Instructor will share surveys, case studies and trends in the Industry. Participants will also learn the law of sunk costs and how to do a cost-benefit analysis.

Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products
Nicole Tesar
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.

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

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

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

Worksheets that Capture SOP Details and Are Compliant
Edward O Connor
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.

CAPA Investigations - Tools for a Compliant and Effective Investigation Process
Carlos Rodriguez Garcia
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.

Family Care and Medical Leave in California - Part II
Jacquiline M Wagner
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.

Customs Single Window: Are You in Compliance?
Grant Smith
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.

Document Retention: Don’t be Overwhelmed by Your Record Management Program
Cathleen M. Hampton
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.

Cuba Sanctions: All You Need To Know
Jennifer Diaz
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.

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

Discussion of Revisions Contained in ISO 13485:2016
Edward Kimmelman
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.

Harassment and Bullying: A Sepsis in Healthcare and Detriment to Patient and Staff Safety
Dr. Susan Strauss
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.

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

Mastering Customs Classification Under the Harmonized Tariff Schedule
Chris Pey
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.

Telecommuting: Effective Policies, Practices, and Programs
Marna Hayden
60 Min
Product Id: 702149
This training on employee telecommuting policies will explain how to develop and implement a formal program on telecommuting for companies that are considering it and how to review and formalize current practices for companies that already have a program.