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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

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Exempt Employees: Taking the Guess Work out of Identifying and Paying Them in 2020
23
/ Jan
Thursday-2020

Exempt Employees: Taking the Guess Work out of Identifying and Paying Them in 2020

  • Speaker: Vicki M. Lambert
  • Product ID: 704126
  • Duration: 90 Min
This training program will discuss the four classification of exempt employees permitted under the IRS code including executive, administrative, professional and outside sales. It will examine the salary level test and the salary basis test.
* Per Attendee
$199
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Dealing with the Disruptive Practitioner in a Legally Compliant Manner
23
/ Jan
Thursday-2020

Dealing with the Disruptive Practitioner in a Legally Compliant Manner

  • Speaker: William Mack Copeland
  • Product ID: 702868
  • Duration: 75 Min
This session will explain how a hospital medical staff should deal with the practitioner who is disruptive of hospital operations. It will discuss disruptive practitioner policies a hospital should have in place and practical tips to correct or terminate the disruptive activity.
* Per Attendee
$199
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California HR Compliance 101 - For New HR and Non HR Managers
24
/ Jan
Friday-2020

California HR Compliance 101 - For New HR and Non HR Managers

  • Speaker: Teri Morning
  • Product ID: 703957
  • Duration: 90 Min
This webinar will offer attendees updates on California employment laws including leaves for employees. It will also highlight common problem areas relating to Wage and Hour in the state, the 12 essential elements of documentation, and accommodations in CA among other key topics.
* Per Attendee
$199
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Analytical Method Validation Under Good Laboratory Practices (GLPs)
28
/ Jan
Tuesday-2020

Analytical Method Validation Under Good Laboratory Practices (GLPs)

  • Speaker: John Fetzer
  • Product ID: 703561
  • Duration: 60 Min
This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
* Per Attendee
$199
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Tax Evasion and Tax Fraud - What it means to you when monitoring BSA and filing SARs
28
/ Jan
Tuesday-2020

Tax Evasion and Tax Fraud - What it means to you when monitoring BSA and filing SARs

  • Speaker: Doug Keipper
  • Product ID: 703110
  • Duration: 60 Min
This training on BSA compliance will help you understand the concept of tax evasion and tax fraud and the difference between the two. Learn the best practices to identify tax fraud and how to report suspicious activity.
* Per Attendee
$199
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Zero-Injury Workplace Culture vs. Safety Culture
30
/ Jan
Thursday-2020

Zero-Injury Workplace Culture vs. Safety Culture

  • Speaker: Michael Aust
  • Product ID: 704986
  • Duration: 60 Min
Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.
* Per Attendee
$199
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Supplier and Service Provider Controls: FDA Expectations
31
/ Jan
Friday-2020

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
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.
* Per Attendee
$299
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Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
3
/ Feb
Monday-2020

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$249
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Human Error Investigations, Root Cause Determination and CAPA Effectiveness
4
/ Feb
Tuesday-2020

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$249
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Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
5
/ Feb
Wednesday-2020

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
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.
* Per Attendee
$249
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Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
6
/ Feb
Thursday-2020

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

  • Speaker: Robert J Russell
  • Product ID: 702038
  • Duration: 90 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
* Per Attendee
$249
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Introduction to Root Cause Investigation for CAPA
7
/ Feb
Friday-2020

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
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.
* Per Attendee
$229
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Stress-Testing in Financial Institutions: Selecting Appropriate Scenarios
7
/ Feb
Friday-2020

Stress-Testing in Financial Institutions: Selecting Appropriate Scenarios

  • Speaker: Fred Vacelet
  • Product ID: 705249
  • Duration: 60 Min
This webinar training on stress testing in financial institutions will depict scenarios, pitfalls to be avoided, and discuss how the choice of the right scenarios can provide good insight into strategic management of a financial institution.
* Per Attendee
$199
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Female to Female Hostility @Workplace: All you need to Know
10
/ Feb
Monday-2020

Female to Female Hostility @Workplace: All you need to Know

  • Speaker: Dr. Susan Strauss
  • Product ID: 704544
  • Duration: 60 Min
This training program will discuss whether women are more hostile among each other in the workplace. It will discuss sexism and stereotypes in our perceptions of women and men’s bullying, the nexus of bullying and harassment, and the impact of bullying on witnesses.
* Per Attendee
$199
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HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It
11
/ Feb
Tuesday-2020

HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705214
  • Duration: 90 Min
This training program will discuss the origin of the HIPAA Breach Notification Rule, how it works, including interactions with other HIPAA rules and penalties for violations. It will also explain how to create the right breach notification policy for your organization and best practices to follow through when an incident occurs.
* Per Attendee
$199
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Recorded/CD
Understanding the FDA Compounding Pharmacies Guidance

Understanding the FDA Compounding Pharmacies Guidance

  • Speaker: Carl Patterson
  • Product ID: 705348
  • Duration: 60 Min
This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
CD/Recorded
$229
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Recorded/CD
Tattoos, Sandals, Yarmulkes, Dress and Appearance: Increasing Legal Challenges for Employees and Employers

Tattoos, Sandals, Yarmulkes, Dress and Appearance: Increasing Legal Challenges for Employees and Employers

  • Speaker: Dr. Susan Strauss
  • Product ID: 704557
  • Duration: 60 Min
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.
CD/Recorded
$229
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Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$299
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Recorded/CD
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

  • Speaker: Kelly Eisenhardt
  • Product ID: 703871
  • Duration: 60 Min
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
CD/Recorded
$179
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Recorded/CD
Understanding and Implementing a Quality by Design (QbD) Program

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
CD/Recorded
$299
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