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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

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Data Blocking and Patient Access of Medical Records under HIPAA - New Focus of Enforcement and Guidance
17
/ Dec
Tuesday-2019

Data Blocking and Patient Access of Medical Records under HIPAA - New Focus of Enforcement and Guidance

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705220
  • Duration: 90 Min
This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
* Per Attendee
$199
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How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability
17
/ Dec
Tuesday-2019

How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704415
  • Duration: 120 Min
This webinar undertakes to explain the process of internal harassment and bullying investigation. Participants will learn how to handle harassment complaints and conduct the investigation to determine facts and minimize liability by analysing evidences, drawing conclusions, writing the formal report outlining the investigation and taking corrective actions where necessary.
* Per Attendee
$179
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How to Think Like a Crook - Money Laundering Prevention
17
/ Dec
Tuesday-2019

How to Think Like a Crook - Money Laundering Prevention

  • Speaker: Doug Keipper
  • Product ID: 702770
  • Duration: 60 Min
This anti-money laundering training will describe the reasons and methods of money laundering in financial institutions. This will help attendees to protect themselves from regulatory risk by establishing an effective anti-money laundering system within their financial institution.
* Per Attendee
$149
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Handling OOS Test Results and Completing Robust Investigations
17
/ Dec
Tuesday-2019

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$249
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Annual Current Good Manufacturing Practices (cGMP) Training
18
/ Dec
Wednesday-2019

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
* Per Attendee
$199
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HIPAA Audits and Enforcement for 2020 and Beyond - Current Issues and Focus for HIPAA Compliance in the Coming Year
7
/ Jan
Tuesday-2020

HIPAA Audits and Enforcement for 2020 and Beyond - Current Issues and Focus for HIPAA Compliance in the Coming Year

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705026
  • Duration: 90 Min
This webinar will discuss HIPAA audit and enforcement regulations and processes for 2020 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.
* Per Attendee
$199
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Writing an Effective SAR Narrative
8
/ Jan
Wednesday-2020

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
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The Business Case for LGBT Inclusion in the Workplace: Navigating Policies, Procedures, Practices and Bathrooms
9
/ Jan
Thursday-2020

The Business Case for LGBT Inclusion in the Workplace: Navigating Policies, Procedures, Practices and Bathrooms

  • Speaker: Dr. Susan Strauss
  • Product ID: 704673
  • Duration: 60 Min
This training program will examine LGBT perceptions and stereotypes and help understand the business case for LGBT inclusion in the workforce. It will also establish gender transition guidelines and list organization best practices to minimize discrimination.
* Per Attendee
$179
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Supplier and Service Provider Controls: FDA Expectations
9
/ Jan
Thursday-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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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
14
/ Jan
Tuesday-2020

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
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Challenges, Opportunities and Compliance Requirements for Same Day ACH (SDA)
16
/ Jan
Thursday-2020

Challenges, Opportunities and Compliance Requirements for Same Day ACH (SDA)

  • Speaker: Donna K Olheiser
  • Product ID: 704019
  • Duration: 60 Min
This training program will detail what just happened with the adoption of the new Same Day ACH Rule and what will it do for the ACH payments network. It will also help identify the impact on financial institutions (ODFIs and RDFIs), including their originators.
* Per Attendee
$199
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Good Documentation Guideline (Chapter <1029> USP)
22
/ Jan
Wednesday-2020

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.
* Per Attendee
$229
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Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
22
/ Jan
Wednesday-2020

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.
* Per Attendee
$149
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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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Recorded/CD
NLRB Effects on Social Media, Non-Union Employers and Other Changes

NLRB Effects on Social Media, Non-Union Employers and Other Changes

  • Speaker: Teri Morning
  • Product ID: 702604
  • Duration: 60 Min
This NLRA compliance webinar will discuss the fundamentals of NLRA and review how recent decisions of the National Labor Relations Board (NLRB) affects both non-union and union employers.
CD/Recorded
$229
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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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Recorded/CD
Mexico Procedures and Documentation

Mexico Procedures and Documentation

  • Speaker: Jan Seal
  • Product ID: 704260
  • Duration: 90 Min
This export requirement training will explain the current procedures and documentation requirements for U.S. exports to Mexico and for imports into Mexico, how to avoid delays, cross-border trucking, mandatory labeling requirements, Mexico's Harmonized Tariff Schedule, and recordkeeping requirements.
CD/Recorded
$229
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Recorded/CD
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
CD/Recorded
$279
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Recorded/CD
Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
CD/Recorded
$299
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