WEBINARS

 

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

 

3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection

webinar-speaker   Angela Bazigos

webinar-time   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.

Recording Available

 

Choosing and Using Key Risk Indicators

webinar-speaker   Mario Mosse

webinar-time   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.

Recording Available

* Per Attendee $249

 

Structuring and Auditing Physician Employment Agreements: Key Stark Law Considerations

webinar-speaker   Joseph Wolfe

webinar-time   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.

Recording Available

 

The New EEO-1 Report: What Employers Need to Know

webinar-speaker   David G Gabor

webinar-time   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.

Recording Available

* Per Attendee $229

 

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

webinar-speaker   Daniel Norwood

webinar-time   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.

Recording Available

* Per Attendee $249

 

Military and USG Construction - the Differences Between OSHA and EM-385

webinar-speaker   John J Meola

webinar-time   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.

Recording Available

 

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