ComplianceOnline

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
26
/ Feb
Tuesday-2019

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

  • Speaker: Laura Brown
  • Product ID: 701947
  • Duration: 60 Min
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
* Per Attendee
$229
CDISC Mapping 1: Specifications and FDA Requirements
27
/ Feb
Wednesday-2019

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
* Per Attendee
$229
FDA Compliance and Clinical Trial Computer System Validation
27
/ Feb
Wednesday-2019

FDA Compliance and Clinical Trial Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 705358
  • Duration: 60 Min
This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
* Per Attendee
$229
21 CFR Part 11 and Annex 11 Compliance; Specifics for Data Integrity with SaaS/Cloud
28
/ Feb
Thursday-2019

21 CFR Part 11 and Annex 11 Compliance; Specifics for Data Integrity with SaaS/Cloud

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$229
Current Concepts and Challenges in Cloud Compliance
28
/ Feb
Thursday-2019

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
* Per Attendee
$229
Country of Origin Marking for Imports/Exports
28
/ Feb
Thursday-2019

Country of Origin Marking for Imports/Exports

  • Speaker: Jan Seal
  • Product ID: 704785
  • Duration: 90 Min
This training program will focus on regulations that apply to most goods imported into the United States and illustrate them with examples. In addition, attendees will learn more about country of origin marking for exports from the United States to other countries.
* Per Attendee
$149
Prevention of Infection in Healthcare Workers
28
/ Feb
Thursday-2019

Prevention of Infection in Healthcare Workers

  • Speaker: Sue Barnes
  • Product ID: 703636
  • Duration: 90 Min
For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and the National Institute for Occupational Safety and Health (NIOSH) recommendations.
* Per Attendee
$199
3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela
28
/ Feb
Thursday-2019

3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela

  • Speaker: Raymond Sullivan
  • Product ID: 704646
  • Duration: 3 hrs
This training program on Latin America import and export will detail the US requirements to export and import procedures to Latin America. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference between automatic and non-automatic import licenses.
* Per Attendee
$299
Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?
28
/ Feb
Thursday-2019

Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?

  • Speaker: Sue Dill Calloway
  • Product ID: 705231
  • Duration: 120 Min
This training program will discuss in detail the CMS requirements for hospitals to help prevent the hospital from being found out of compliance with the grievance regulations. It will also cover a new law under the OCR Section 1557 which requires the hospital to have a new process for handling discrimination complaints.
* Per Attendee
$229
FDA Regulations for Environmental Monitoring (EM) Program
4
/ Mar
Monday-2019

FDA Regulations for Environmental Monitoring (EM) Program

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 90 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
* Per Attendee
$199
Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
4
/ Mar
Monday-2019

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 90 Min
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
* Per Attendee
$299
Female to Female Hostility @Workplace: All you need to Know
5
/ Mar
Tuesday-2019

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
Root Cause Analysis - The Heart of Corrective Action
5
/ Mar
Tuesday-2019

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* Per Attendee
$199
Writing an Effective SAR Narrative
5
/ Mar
Tuesday-2019

Writing an Effective SAR Narrative

  • Speaker: Doug Keipper
  • Product ID: 702993
  • Duration: 60 Min
This BSA compliance training on Suspicious Activity Reporting (SAR) will provide details on how to prepare a SAR (Suspicious Activity Reporting) narrative that meets examiner scrutiny and provides necessary detail for law enforcement.
* Per Attendee
$149
Fragrance Sensitivity in the Workplace and ADA - Your Perfume is Making Me Sick!
6
/ Mar
Wednesday-2019

Fragrance Sensitivity in the Workplace and ADA - Your Perfume is Making Me Sick!

  • Speaker: Elga Lejarza
  • Product ID: 705320
  • Duration: 60 Min
It took decades for the workplace to acknowledge the dangers of smoking; fragrance sensitivity is following the same trajectory. This webinar training will explore how the Americans with Disability Act defines fragrance sensitivity and the broader definition under the Amendment Act. It will further discuss developing a workplace fragrance sensitivity policy and recent significant fragrance sensitivity cases.
* Per Attendee
$149
Recorded/CD
Harmonized Tariff Schedule Classification

Harmonized Tariff Schedule Classification

  • Speaker: Jan Seal
  • Product ID: 705224
  • Duration: 90 Min

Understand the rules that are required to classify products in the Harmonized Tariff Schedule. Learn to minimize errors in classification and better prepare companies for import/export audits from the government. The webinar will also assist companies who are eligible for free trade agreements, ex. NAFTA, and other agreements, in properly completing Certificates of Origin.

The Harmonized Tariff Schedule (HTS) is used by over 200 countries, territories, or customs unions around the world to assign a number to each product to establish the appropriate duty that should be paid when goods are imported into a country. The HTS is also used to determine whether goods are subject to quotas or free trade agreements. Proper classification is also vital for establishing eligibility under many free trade agreements, i.e. completion of the NAFTA Certificate of Origin for trade between U.S., Canada, and Mexico as well as trade agreements between the U.S. and Chile, Singapore, Australia, and the Central America-Dominican Republic.

CD/Recorded
$179
Recorded/CD
Bundled Payment Review: How Case Management Can Play a Strategic Role

Bundled Payment Review: How Case Management Can Play a Strategic Role

  • Speaker: Toni Cesta
  • Product ID: 705119
  • Duration: 60 Min
This webinar will teach you how bundled payments actually work as they move from demonstration to reality. It will discuss how case management must become a fully integrated across the continuum model.
CD/Recorded
$249
Recorded/CD
Travel and Expense Policy Development and Automation

Travel and Expense Policy Development and Automation

  • Speaker: Brian G Rosenberg
  • Product ID: 704880
  • Duration: 60 Min
In this webinar training, you will learn how to create, maintain, and enforce a T&E policy for your organization. The Instructors will discuss the key components and best practices for policies.
CD/Recorded
$229
Recorded/CD
A+ Compliance with Mental Disorders in the Workplace: Surviving the FMLA, ADA and Workers Compensation Tsunami

A+ Compliance with Mental Disorders in the Workplace: Surviving the FMLA, ADA and Workers Compensation Tsunami

  • Speaker: Elga Lejarza
  • Product ID: 703914
  • Duration: 90 Min
This training program will discuss the knowledge and skills needed to develop a comfortable level managing the Family and Medical Leave Act (FMLA), the Americans with Disabilities Act (ADA) and Workers Compensation, separately or when they interconnect. At the end of the webinar, attendees will understand the interplay of these laws to assure legal compliance as well as to provide employees with the benefits and protections each law provides.
CD/Recorded
$0
Recorded/CD
Introduction to Root Cause Investigation for CAPA

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.
CD/Recorded
$299
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