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Home › Online Training ›FDA Training ›  Regulations & Guidances

FDA Regulations and Guidance Training - Live Webinars, Recordings & CDs

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Fair Debt Collection Practices Act - FDCPA, FCRA, Easily-Broken HIPAA, Civil Liability, Bad Check Laws, Promissory Notes, Mini-Miranda Warning
17
/ Oct
Wednesday-2018

Fair Debt Collection Practices Act - FDCPA, FCRA, Easily-Broken HIPAA, Civil Liability, Bad Check Laws, Promissory Notes, Mini-Miranda Warning

  • Speaker: David Sanders
  • Product ID: 704686
  • Duration: 90 Min
In this fast-paced and informative training program, attendees will learn exactly what violates the Fair Debt Collection Practices Act (FDCPA) and other laws that lead to costly fines and judgments. The program will also overview consumer vs. commercial bankruptcy and the differences between Chapter 7, 11 and 13.
* Per Attendee
$199
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Accounts Payable Fraud - Detecting and Preventing AP Fraud
17
/ Oct
Wednesday-2018

Accounts Payable Fraud - Detecting and Preventing AP Fraud

  • Speaker: Peter Goldmann
  • Product ID: 702441
  • Duration: 100 Min
This webinar will guide you through the critical steps in ensuring strong controls for the accounts payable (AP) function and provide practical 'how to' guidance for minimizing your organization’s exposure to AP fraudsters.
* Per Attendee
$199
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"Front-End, Middle, and Back-End" Approach to Credit Management
19
/ Oct
Friday-2018

"Front-End, Middle, and Back-End" Approach to Credit Management

  • Speaker: David L Osburn
  • Product ID: 705808
  • Duration: 60 Min
This credit management webinar will discuss the credit analysis process, how to do financial statement analysis and how to do effective cash management using various tools and techniques and how to use various collection techniques (manage legal issues and using negotiation skills) and overall how to manage the collection process.
* Per Attendee
$169
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How to Effectively Manage a Construction Project
19
/ Oct
Friday-2018

How to Effectively Manage a Construction Project

  • Speaker: Keith Warwick
  • Product ID: 704858
  • Duration: 90 Min
This webinar training will explain the process to effectively manage construction projects. The Instructor will discuss reviews of plans and specification, inspection program, order of operations, identification of hazards and safety controls.
* Per Attendee
$149
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Building a World Class Accounts Payable Operation: P2P, AP
19
/ Oct
Friday-2018

Building a World Class Accounts Payable Operation: P2P, AP

  • Speaker: Brian G Rosenberg
  • Product ID: 703979
  • Duration: 60 Min
This training program will help attendees examine if their AP department matches world-class standards. Attendees will learn key success factors to an optimal accounts payable operation. They will also gain in depth knowledge on the must-have technologies for any AP operation and learn how to design processes to fully leverage those capabilities. The webinar will also discuss balancing controls with efficiency and how to create a fraud-proof department. Attendees will learn about the most important metrics for any AP department and how to develop strategies to improve those metrics.
* Per Attendee
$179
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Proposed NACHA Operating Rules - Hear the Latest NEWS in the Rules Space
22
/ Oct
Monday-2018

Proposed NACHA Operating Rules - Hear the Latest NEWS in the Rules Space

  • Speaker: Donna K Olheiser
  • Product ID: 705835
  • Duration: 60 Min
This NACHA Operating Rules training session will provide the details on the proposed changes that potentially may be happening in the future. How it is going to impact you and what can you do about it.
* Per Attendee
$149
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Basic, Easy-to-Follow Pivot Tables Including an Introduction to Dashboards
22
/ Oct
Monday-2018

Basic, Easy-to-Follow Pivot Tables Including an Introduction to Dashboards

  • Speaker: Joe Weil
  • Product ID: 705044
  • Duration: 100 Min
This Excel training program will guide users in employing Pivot Table filters to analyze data, designing a Pivot Chart from a Pivot Table, developing Slicers for User Interactive Filters, and more. It will also take attendees through the first steps in dashboard design using Pivot Tables.
* Per Attendee
$179
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
22
/ Oct
Monday-2018

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

  • Speaker: Roger Cowan
  • Product ID: 703727
  • Duration: 60 Min
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
* Per Attendee
$199
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EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development
23
/ Oct
Tuesday-2018

EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development

  • Speaker: Laura Brown
  • Product ID: 705850
  • Duration: 90 Min
This webinar will discuss the new GDPR regulation requirements in the context of clinical trial data, how it applies to clinical trials and pharma industry, the personal data types including clinical trial data, what are the rights of clinical trials subjects, data access requests, informed consent, how to transfer clinical trial data outside EU, data breach reporting, penalties and how to put a data governance program and process to comply with GDPR regulations.
* Per Attendee
$169
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BREXIT – What's Changing for Life Science Product License Holders/Manufacturers and What You Need to Do Right Now?
23
/ Oct
Tuesday-2018

BREXIT – What's Changing for Life Science Product License Holders/Manufacturers and What You Need to Do Right Now?

  • Speaker: Robert J Russell
  • Product ID: 705811
  • Duration: 90 Min
This webinar will discuss how to accurately assess the impact of Brexit up on your operations and existing licensed life products in the UK and EU. How to plan to becoming compliant on “what is known” and how to be agile as the rest of implications become clearer. Impact on Filing Registrations with EMA in Q1 2019, How Will the UK’s Withdrawal Effect the Sunset Clause.
* Per Attendee
$199
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Stunning Changes in FDA's Software Regulation
23
/ Oct
Tuesday-2018

Stunning Changes in FDA's Software Regulation

  • Speaker: Casper Uldriks
  • Product ID: 705820
  • Duration: 60 Min
This webinar will highlight the changing circumstances with respect to software regulations and FDA’s approach from a regulation to voluntary standard. How to understand the qualifications and terms of participation to clear its software for marketing, what to do in case of cybersecurity intrusion and how to update regulatory program as mobile apps are removed from FDA’s regulatory oversight.
* Per Attendee
$299
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Gaining and Re-establishing Control of Your Cleanroom
23
/ Oct
Tuesday-2018

Gaining and Re-establishing Control of Your Cleanroom

  • Speaker: Joy McElroy
  • Product ID: 705317
  • Duration: 60 Min
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
* Per Attendee
$199
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Artificial Intelligence and Human Resources - Plan for Action
23
/ Oct
Tuesday-2018

Artificial Intelligence and Human Resources - Plan for Action

  • Speaker: Tony Miller
  • Product ID: 705845
  • Duration: 60 Min
In this HR webinar attendees will learn how to implement artificial intelligence policies in HR process like (recruitment, performance appraisal, training & planning etc.) and what are the impacts of artificial intelligence on employment numbers commencing 2020 and beyond. You will understand how an integrated AI program works and benefits.
* Per Attendee
$149
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Fishbone Diagramming
23
/ Oct
Tuesday-2018

Fishbone Diagramming

  • Speaker: Michael Abitz
  • Product ID: 705338
  • Duration: 90 Min
This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.
* Per Attendee
$179
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Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging
23
/ Oct
Tuesday-2018

Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

  • Speaker: John J Meola
  • Product ID: 705493
  • Duration: 90 Min
This webinar will review the best practices associated with use of ladders of all types, including the selection, inspection, storage and transport of ladders, along with safe practice when erecting, climbing, working from and descending a ladder. It will also discuss the process and practices related with aerial lifts and working from buckets on an extended boom.
* Per Attendee
$149
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Recorded/CD
Recognizing and Managing Emerging Operational Risks

Recognizing and Managing Emerging Operational Risks

  • Speaker: Daniel Clark
  • Product ID: 705588
  • Duration: 60 Min
This webinar reviews the different definitions behind the concept of emerging risks, the different types of operational risks impacting firms today. Then, the webinar moves on to the principles of monitoring and mitigating some of these emerging risks, highlighting useful principles of risk identification and risk management.
CD/Recorded
$199
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Recorded/CD
Data Integrity of GxP/GMP Data: e-Discovery and Crisis Preparedness

Data Integrity of GxP/GMP Data: e-Discovery and Crisis Preparedness

  • Speaker: Eleonora Babayants
  • Product ID: 705781
  • Duration: 90 Min
Learn how to secure, manage and govern data as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit. Understand GMP requirements for IT systems, data security and data governance procedures, e-discovery and crisis preparedness plan and how to implement it in time.
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Recorded/CD
Establishing a Medical Device Security Program

Establishing a Medical Device Security Program

  • Speaker: Robert Mai
  • Product ID: 705841
  • Duration: 60 Min
In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment. It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
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Recorded/CD
ICD-10-CM Official Guidelines for Coding and Reporting - FY 2019

ICD-10-CM Official Guidelines for Coding and Reporting - FY 2019

  • Speaker: Pamela Joslin
  • Product ID: 705826
  • Duration: 60 Min
This webinar will discuss overviews of each of the four sections of 2019 ICD-10-CM Guidelines for Coding and Reporting. These are the guidelines that payers use when processing your claims. It will teach how accurate ICD-10 reporting ties to patient encounter, reimbursement and reporting, how to use chapter 7, how to use the A, D, S & documentation requirements. Expert will give examples of commonly used guidelines, such as sequencing, code first, code also, etiology and manifestation.
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Recorded/CD
Medical Devices: Navigating FDA Requirements for Non-US Organizations

Medical Devices: Navigating FDA Requirements for Non-US Organizations

  • Speaker: Jonathan Lee
  • Product ID: 705823
  • Duration: 90 Min
This webinar will give an understanding of various processes and compliance requirements for US market entry by non-US medical device manufacturer. It will teach how to comply with pre-market requirements, how to get submission & product clearance/approval, what are various activities to be done post market entry of products (surveillance, reporting, audit, correction & removal).
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