WEBINARS

 

Nutrition and Health Claims Regulation (NHCR) in the European Union

webinar-speaker   Vicente Rodriguez

webinar-time   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.

Recording Available

 

Validation of Complex Cell-Based Potency Methods

webinar-speaker   Gwen Wise Blackman

webinar-time   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.

Recording Available

* Per Attendee $179

 

Preventative Medicine: Is it Time to Streamline Your Physician Enterprise Structure so it Stands the Test of Time

webinar-speaker   Joseph Wolfe

webinar-time   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.

Recording Available

 

Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   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.

Recording Available

 

OSHA - 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement

webinar-speaker   James T. Dufour

webinar-time   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.

Recording Available

* Per Attendee $199

 

Medical Device Software Verification and Validation

webinar-speaker   Nancy Knettell

webinar-time   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.

Recording Available

* Per Attendee $169

 

Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

webinar-speaker   Stephanie Cooke

webinar-time   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.

Recording Available

* Per Attendee $279

 

California Environmental Regulations - Differences Between Federal EPA and State Requirements

webinar-speaker   James T. Dufour

webinar-time   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.

Recording Available

* Per Attendee $179

 

California’s Mandatory Paid Sick Leave - Recordkeeping, Anti-Retaliation Requirements and More

webinar-speaker   Jacquiline M Wagner

webinar-time   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.

Recording Available

* Per Attendee $179

 

Patient Rights, Medical Records and HIPAA - What You Need to Know as a Healthcare Provider

webinar-speaker   Jay Hodes

webinar-time   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.

Recording Available

* Per Attendee $249

 

Paying Employees from Start to Finish and Everywhere in Between

webinar-speaker   Vicki M. Lambert

webinar-time   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.

Recording Available

 

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

webinar-speaker   Angela Bazigos

webinar-time   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?

Recording Available

 

Exempt v. Nonexempt: Ensuring Proper Classification of Employees for Compliance with Federal Overtime Laws

webinar-speaker   Allen Kato

webinar-time   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.

Recording Available

* Per Attendee $249

 

Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions

webinar-speaker   Suzanne Bullitt

webinar-time   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.

Recording Available

* Per Attendee $179

 

Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions

webinar-speaker   Suzanne Bullitt

webinar-time   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.

Recording Available

* Per Attendee $179

 

How to Finally Write Those Payroll Procedures

webinar-speaker   Vicki M. Lambert

webinar-time   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.

Recording Available

* Per Attendee $249

 

Wage and Hour Best Practices for 2018: Companies Must Be Aware of How This Will Impact Their Risk Management Strategy!

webinar-speaker   Margie Pacheco Faulk

webinar-time   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.

Recording Available

 

How to Avoid HIPAA Fines and Penalties

webinar-speaker   Jay Hodes

webinar-time   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.

Recording Available

* Per Attendee $179

 

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

webinar-speaker   Edwin Waldbusser

webinar-time   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.

Recording Available

 

Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)

webinar-speaker   Stephanie Cooke

webinar-time   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.

Recording Available

 

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