Mission Possible: How to Obtain A Zero Injury Culture In The Workplace
Michael Aust
60 Min
Product Id: 704739
This zero tolerance for injuries training program will discuss what it means to have a safety culture on site. It will also identify the four steps of the safety maturity curve and discuss employee and employer rights and responsibilities at each step of the maturity curve. The instructor will explain the benefits of sustaining a safety culture in the workplace.
HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic
Ronald Adler
90 Min
Product Id: 703882
This HR Audit webinar will cover key strategic, operational, and compliance HR management issues. The objective is to provide the attendee with the key areas that should be addressed in conducting an HR audit, an understanding of critical tasks to be completed, and an update how federal and state employment laws may affect the scope and the reporting of the HR audit.
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
Karl M. Nobert
90 Min
Product Id: 701927
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Employee Handbooks: Key issues Post Pandemic
Ronald Adler
90 Min
Product Id: 703910
This webinar discusses the key employment policies that should be incorporated in every employee handbook. The webinar further identifies policies statements that add value to the employer-employee relationship and discusses key issues that will require inclusion in the future.
Implementation and Management of GMP Data Integrity
Danielle DeLucy
90 Min
Product Id: 705029
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
Pricing Contractor Jobsite Overhead Delay Costs
Jim Zack
90 Min
Product Id: 704367
After attending this training program, attendees will have a better understanding of the issues concerning the pricing of contractor delay damages. Contractors will gain knowledge about the various methods of calculating extended field office overhead costs. Owners will learn some contractual methods for predetermining this element of delay costs in order to prevent the need for end of the job audits or disputes over such costs.
Tattoos, Sandals, Yarmulkes, Dress and Appearance: Increasing Legal Challenges for Employees and Employers
Dr. Susan Strauss
60 Min
Product Id: 704557
This webinar training will explain the role of HR professionals and managers in implementing discrimination-free dress code to ensure all job candidates and employees are treated fairly and equitably. Dress codes are receiving a fair amount of attention in the courts these days with number of precedent setting lawsuits dealing with dress codes’ requirements. The instructor will explain how your current dress code can discriminate against potential and current employees based on their gender, religion, and race, to name a few and lead to lawsuits.
Introduction to Root Cause Investigation for CAPA
Vanessa Lopez
60 Min
Product Id: 704409
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
Supplier and Service Provider Controls: FDA Expectations
Vanessa Lopez
120 Min
Product Id: 704844
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
Best Practices for Setting Up a Global International Trade Compliance Program
Deep SenGupta
60 Min
Product Id: 703708
Attend this webinar to learn how to evaluate the trade compliance risk for your worldwide subsidiaries and how to ensure that your worldwide subsidiaries are adequately managing their trade compliance risk.
Import and Export - Improving Your International Trade Compliance Score
Deep SenGupta
60 Min
Product Id: 703961
This international trade compliance training program will evaluate strategies such as drawback, foreign trade zones or free trade agreements. It will also offer guidance and best practice strategies for several import/export practices such as methodology for measuring trade compliance score, and determining export control classification number.
Japan: Regulatory Compliance Requirements for Life Science Products
Robert J Russell
90 Min
Product Id: 702979
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Prevention of Infection in Healthcare Workers
David Woodard
60 Min
Product Id: 703636
For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and the National Institute for Occupational Safety and Health (NIOSH) recommendations.
Implementing a Bullet Proof Quality System for FDA Audit Success
Meena Chettiar
60 Min
Product Id: 705400
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
Beyond Handbooks, Benefits, and Photo IDs: The Role of HR and Management in New Employee Onboarding
Dr. Susan Strauss
90 Min
Product Id: 704627
This training program will discuss a new employee’s role in his/her orientation and difference between orientation to the organization and orientation to the department. The program will also explain gap analysis, force field analysis, and SWOT analysis in assessing your organization’s onboarding requirements.
US Import: How to prepare for a Customs Audit
Deep SenGupta
60 Min
Product Id: 703612
This webinar will explain the structure and timeline of a customs audit, and teach attendees how to successfully prepare for an audit. Attendees will learn the best practices for trade compliance and customs compliance that you can implement while importing/exporting to minimize penalties. Also you will learn how to establish a reasonable care process, identify the characteristic of internal controls along-with real life examples of implementing a compliance program successfully.
NAFTA: Understanding the Rules of Origin and Certificate of Origin Requirements
Douglas Cohen
60 Min
Product Id: 703168
This training on trade compliance will help the attendees understand the rules to qualify your imports/exports between United States, Mexico, and Canada. You will also learn best practices on how to complete the NAFTA certificate of origin to avoid penalties.
The Business Case for LGBT Inclusion in the Workplace: Navigating Policies, Procedures, Practices and Bathrooms
Dr. Susan Strauss
60 Min
Product Id: 704673
This training program will examine LGBT perceptions and stereotypes and help understand the business case for LGBT inclusion in the workforce. It will also establish gender transition guidelines and list organization best practices to minimize discrimination.
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
Vanessa Lopez
90 Min
Product Id: 704758
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
Understanding FDA Design Verification and Validation Requirements for Medical Devices
Meena Chettiar
75 Min
Product Id: 705331
This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.







