Nutrition and Health Claims Regulation (NHCR) in the European Union
Vicente Rodriguez
60 Min
Product Id: 705492
This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.
Validation of Complex Cell-Based Potency Methods
Gwen Wise Blackman
60 Min
Product Id: 705172
Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.
Preventative Medicine: Is it Time to Streamline Your Physician Enterprise Structure so it Stands the Test of Time
Joseph Wolfe
60 Min
Product Id: 705437
The webinar will focus on the path most health care organizations in the country have taken to integrate along with the internal fragmentation that often remains after the deals are over. It will also discuss emerging best practices to manage fragmentation and risk.
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 703373
This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.
OSHA - 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement
James T. Dufour
90 Min
Product Id: 701836
Learn 10 major difference between Cal/OSHA and Federal OSHA and how to respond to it in case of OSHA inspection.
Medical Device Software Verification and Validation
Nancy Knettell
60 Min
Product Id: 705393
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
Bioavailability and Bioequivalence Studies submitted in NDAs and INDs
Stephanie Cooke
90 Min
Product Id: 705506
Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
California Environmental Regulations - Differences Between Federal EPA and State Requirements
James T. Dufour
90 Min
Product Id: 701899
This environmental regulation training will explain in details the differences between California Environmental Regulations and U.S. EPA and Other State Requirements.
California’s Mandatory Paid Sick Leave - Recordkeeping, Anti-Retaliation Requirements and More
Jacquiline M Wagner
90 Min
Product Id: 704446
This training program will discuss posting and notice requirements, recordkeeping requirements, anti-retaliation requirements and penalties for failing to comply with the mandatory paid sick leave requirements.
Patient Rights, Medical Records and HIPAA - What You Need to Know as a Healthcare Provider
Jay Hodes
60 Min
Product Id: 705213
Attendees will leave the course clearly understanding of all the requirements that must be in place for meeting this rule for the protection of personal health information their organizations maintain, create, transmit, or store. After completing this course, a healthcare provider will have a clear understanding for what needs to be place when it comes to meeting these HIPAA requirements for medical records.
Paying Employees from Start to Finish and Everywhere in Between
Vicki M. Lambert
90 Min
Product Id: 704552
This webinar focuses on the rules and regulations for paying employees from the time they are hired to the date of termination. The Instructor covers areas like; how often an employee must be paid to the methods that may be used in the different states. The training also includes how and when to pay terminated employees. It covers all 50 states including state charts for each section.
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)
Angela Bazigos
90 Min
Product Id: 705488
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
Exempt v. Nonexempt: Ensuring Proper Classification of Employees for Compliance with Federal Overtime Laws
Allen Kato
90 Min
Product Id: 704242
This training program will highlight exempt versus nonexempt classification of employees for compliance with federal overtime laws. It will include best practices and practical steps to ensure lawful classifications.
Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions
Suzanne Bullitt
60 Min
Product Id: 704138
This training program will discuss why an effective export control program (ECP) consists of many processes that connect, intersect, and overlap. It is vital that employees responsible for export compliance know the requirements of Title 15, CFR, Part 30, and the responsibilities of U.S. parties at the time of export. This online training will provide compliance materials that examine U.S. Customs and Border Protection regulations for the international logistic arena.
Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions
Suzanne Bullitt
60 Min
Product Id: 705225
This training program will discuss why an effective export control program (ECP) consists of many processes that connect, intersect, and overlap. It is vital that employees responsible for export compliance know the requirements of Title 15, CFR, Part 30, and the responsibilities of U.S. parties at the time of export. This online training will provide compliance materials that examine U.S. Customs and Border Protection regulations for the international logistic arena.
How to Finally Write Those Payroll Procedures
Vicki M. Lambert
90 Min
Product Id: 704816
This training program will help set you on your way to writing the procedures for your payroll department. By showing how cutting the task down into 30-minute increments increases your efficiency, attendees will learn to write procedures in hours instead days and weeks.
Wage and Hour Best Practices for 2018: Companies Must Be Aware of How This Will Impact Their Risk Management Strategy!
Margie Pacheco Faulk
90 Min
Product Id: 705206
Companies are often confused or resentful of continued regulations and find it as an obstacle in running, growing and expanding their companies - and it can be a challenge for companies to keep track of regulatory changes and deadlines. This webinar training will provide business owners, human resources professional or other roles handling their workplace risk management situations, the top situations that can impact the DOL regulations.
How to Avoid HIPAA Fines and Penalties
Jay Hodes
60 Min
Product Id: 705294
In this webinar, attendees will leave the course learning how to avoid possible HIPAA fines and penalties by making sure their organization has all the requirements in place for a compliance program.
Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity
Edwin Waldbusser
60 Min
Product Id: 705432
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)
Stephanie Cooke
90 Min
Product Id: 705477
This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.







