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.
3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection
Angela Bazigos
3.5 hrs
Product Id: 705520
This Virtual Boot Camp will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.
Choosing and Using Key Risk Indicators
Mario Mosse
60 Min
Product Id: 704948
This webinar will discuss the significance, nature and types of KRIs. The instructor will discuss how to develop, evaluate and implement KRIs in accordance with organization’s risk culture and create strategies for effective reporting of risk indicators that lead to management action.
Structuring and Auditing Physician Employment Agreements: Key Stark Law Considerations
Joseph Wolfe
60 Min
Product Id: 705436
This webinar will provide an overview of the Stark Law, including its 2016 changes. It will also discuss best practices for negotiating and drafting employment agreements on behalf of health systems, hospitals, medical groups and physician practices.
The New EEO-1 Report: What Employers Need to Know
David G Gabor
90 Min
Product Id: 705511
In this interactive webinar you will learn about significant changes made by the Equal Employment Opportunity Commission to the EEO-1 survey and its impact on businesses. It is important for businesses to take steps now in order to prepare for the impact of these changes.
Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists
Daniel Norwood
90 Min
Product Id: 705169
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.
Military and USG Construction - the Differences Between OSHA and EM-385
John J Meola
60 Min
Product Id: 705507
This webinar will discuss the major differences and distinctions between the USACE EM 385 and OSHA and how you can interpret and navigate both systems to assure a successful and accident free job.







