INCOTERMS Made Easy - Decoding your Shipment
John Dunlop
60 Min
Product Id: 705597
This 60-minute webinar will help exporters understand International Commercial Terms, or (INCOTERM) Any company that imports or exports goods internationally needs to know which International Commercial Term (INCOTERM) to use for each shipment.
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Joy McElroy
120 Min
Product Id: 704086
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Overview of Penalties for different OSHA Violations: Cost of Noncompliance to Double!
Michael Aust
60 Min
Product Id: 706724
OSHA penalties have increased continuously for over 5 consecutive years! The new penalties took effect August 2, 2016. Any citations issued by OSHA on or after this date will be subject to the new penalties if the related violations occurred after November 2, 2015.
Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes
Betty Lane
75 Min
Product Id: 702502
This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.
Conducting Sound Sexual Harassment Investigations
Melveen Stevenson
60 Min
Product Id: 706723
Sexual harassment continues to be a problem in the workplace even with existing and developing regulations to train employees and managers against engaging in such behavior. The obligation to conduct a sound and thorough investigation by an appropriate investigator is mostly understood. This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting sexual harassment investigations in the work environment that will protect employees and the company as well.
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
Laura Brown
60 Min
Product Id: 701947
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
Holy Smoke! An Employer's Guide to Medical Marijuana in the Workplace
Janette Levey Frisch
90 Min
Product Id: 705703
In this webinar, we will explore the challenges employers now face in managing employee marijuana use. We will, also discuss applicable laws (both statutes and cases) addressing this subject, analyze recent court cases. The laws, of course vary by state. You will receive an overview of where many of the different states are currently holding with respect to medical and recreational marijuana and employer’s rights and obligations.
Conducting Effective, Legally-Compliant Investigations of Harassment & Bullying Allegations
Diane L Dee
90 Min
Product Id: 705542
Missteps in handling sensitive employee issues could result in your organization writing a check with a lot of zeros on it. How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line. Cultural and generational diversity is changing the landscape of the US workforce. That diversity can become fuel for all types of litigation. Understanding how to effectively conduct workplace investigations can greatly reduce the chances of your organization being sued.
Mobile Apps as Medical Devices
John E Lincoln
60 Min
Product Id: 706721
The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.
Human Error Reduction in GMP Manufacturing
Ginette M Collazo
90 Min
Product Id: 704107
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
Jeff Kasoff
60 Min
Product Id: 700986
This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.
On the Alert: Software License Audit Readiness
Robert Davis
60 Min
Product Id: 706722
Despite growing available information and training materials about the critical value of Software Asset Management, many organizations still find themselves unprepared for a software license compliance audit. A software license audit can cause severe disruption and takes time and resource away from business as usual. In this webinar, Dr. Davis will discuss the different approaches to achieving software license contracting compliance.
Using Excel to Detect Fraud
Joe Weil
100 Min
Product Id: 705022
This webinar training pays for itself in terms of your firm's potential savings and detection of fraud. The training is designed to both prevent and detect fraud. We first teach you how to establish an administrative environment where fraud is less likely to occur. We’ll then examine Excel tools that are used by CPAs and Internal Auditors to detect fraud.
How to Understand and Analyze Financial Statements for Non-Financial Professionals
Joe Weil
90 Min
Product Id: 704958
This webinar will be an informative session for all financial and non-financial professionals to understand the financial statements like balance sheet, income statement, cash flow and more. Participants will learn how to analyze and interpret these statements to assess the profitability, liquidity, efficiency and leverage of their company.
The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up
Jeff Kasoff
60 Min
Product Id: 701568
This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
Assuring IT Regulatory Compliance
Robert Davis
60 Min
Product Id: 706715
Government laws and regulations usually require an entity’s management to design, implement, and maintain a control system. However, controls existence and effectiveness verification are commonly an external and internal statutory audit responsibility. Auditors that conduct entity compliance attestation engagements focus on examining, reviewing, or performing agreed-upon procedures regarding a subject matter or assertion about a subject matter and reporting evidentially supported results.
The Fallacious Fecal Coliform or What is a Fecal Coliform Anyway?
Michael Brodsky
60 Min
Product Id: 706710
All public water systems (PWSs), except aircraft PWSs subject to the Aircraft Drinking Water Rule (ADWR) (40 CFR 141 Subpart X), must comply with the RTCR as of April 1, 2016. Are you in compliance 5 years later? In this webinar, learn what do you need to do to be in compliance?
Making your Pitch Organizing Your Thoughts and Ideas to be Credible
Audrey Halpern
60 Min
Product Id: 706709
The ability to present articulately to management, to the customer, or a non-tech audience can significantly enhance your credibility. Delivering engaging presentations at work or professional events is a way to share your ideas and gain a reputation as a valued employee and an expert in your field.
Addressing Drug Use and the Changing Legal Environment
Greg Chartier
60 Min
Product Id: 706708
Cannabis, or marijuana, is illegal under federal law. However, at least 30 states and the District of Columbia have legalized marijuana for medicinal use and nine states, soon to be more, have legalized it for recreational use. This conflict presents a unique challenge to employers. At the same time, the illegal use of legal prescription drugs has reached, in the words of the Center for Disease Control, epidemic status. What do employers need to know about this new drug environment at work? What policies and procedures need to be addressed? How do employers comply with the new regulations? What about my pre-employment drug testing program? These questions and others will be answered by this webinar.
Developing Staffing Models for Clinical Research Finance Structure
Mary Veazie
120 Min
Product Id: 706707
A key component of building a clinical research finance team is creating a staffing model that will support the health system’s clinical research portfolio. This course focuses on key metrics and KPIs to help attendees develop a staffing model for their organization.