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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

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Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
2
/ Apr
Thursday-2020

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • 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
$249
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Process Validation - Overview of Why and How
7
/ Apr
Tuesday-2020

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
* Per Attendee
$199
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HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
9
/ Apr
Thursday-2020

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

  • Speaker: Roger Cowan
  • Product ID: 703831
  • Duration: 60 Min
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.
* Per Attendee
$229
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Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Apr
Thursday-2020

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.
* Per Attendee
$249
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Handling OOS Test Results and Completing Robust Investigations
9
/ Apr
Thursday-2020

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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Personal and Business Tax Returns Analysis - 1040 Federal Tax Returns, K-1 Forms and Tax Code Updates
13
/ Apr
Monday-2020

Personal and Business Tax Returns Analysis - 1040 Federal Tax Returns, K-1 Forms and Tax Code Updates

  • Speaker: David L Osburn
  • Product ID: 705011
  • Duration: 90 Min
This personal and business tax returns analysis training program will focus on key areas such as 1040 federal tax returns, K-1 forms, and tax code updates and how they affect bank’s clients. It will also discuss the structure of a C corporation, S corporation, and Partnership (including LLC) tax return.
* Per Attendee
$149
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Validation of HPLC/UPLC Methodologies
14
/ Apr
Tuesday-2020

Validation of HPLC/UPLC Methodologies

  • Speaker: John Fetzer
  • Product ID: 705291
  • Duration: 60 Min
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
* Per Attendee
$229
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How to Think Like a Crook - Money Laundering Prevention
16
/ Apr
Thursday-2020

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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Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability
20
/ Apr
Monday-2020

Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704699
  • Duration: 75 Min
This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.
* Per Attendee
$199
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Employee Handbooks: 2020 Update on Policy and Procedures
21
/ Apr
Tuesday-2020

Employee Handbooks: 2020 Update on Policy and Procedures

  • Speaker: Ronald Adler
  • Product ID: 703910
  • Duration: 90 Min
This training program will discuss key employment policies that should be incorporated in every employee handbook. The webinar will further discuss policy statements that add value to the employer-employee relationship and will list key issues that will require inclusion in the future.
* Per Attendee
$199
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Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert
23
/ Apr
Thursday-2020

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

  • Speaker: Karl M. Nobert
  • Product ID: 703313
  • Duration: 90 Min
This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.
* Per Attendee
$249
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Root Cause Analysis - The Heart of Corrective Action
23
/ Apr
Thursday-2020

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
$229
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Compliance Measures for Case Management Professionals
23
/ Apr
Thursday-2020

Compliance Measures for Case Management Professionals

  • Speaker: Toni Cesta
  • Product ID: 705318
  • Duration: 60 Min
This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.
* Per Attendee
$199
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Understanding FDA Design Verification and Validation Requirements for Medical Devices
27
/ Apr
Monday-2020

Understanding FDA Design Verification and Validation Requirements for Medical Devices

  • Speaker: Meena Chettiar
  • Product ID: 705331
  • Duration: 75 Min
This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.
* Per Attendee
$229
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Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
29
/ Apr
Wednesday-2020

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

  • Speaker: William Mack Copeland
  • Product ID: 705230
  • Duration: 60 Min
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
* Per Attendee
$199
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Recorded/CD
Workplace Investigations - Witnesses Interviews

Workplace Investigations - Witnesses Interviews

  • Speaker: Teri Morning
  • Product ID: 703048
  • Duration: 60 Min
This training will provide you the best practices on how to effectively interview witnesses while conducting workplace investigations. You will also learn how to avoid retaliatory behavior towards individuals involved in investigations or making complaints.
CD/Recorded
$229
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Recorded/CD
HR 101 for Non-HR Leaders

HR 101 for Non-HR Leaders

  • Speaker: Teri Morning
  • Product ID: 703611
  • Duration: 60 Min
This webinar will detail key HR concepts and discuss best practices for recruitment, compensation and performance appraisals. Attendees from a non-HR background will find this course an excellent introduction to HR concepts and processes.
CD/Recorded
$229
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Recorded/CD
California HR Compliance 101 - For New HR and Non HR Managers

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.
CD/Recorded
$249
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Recorded/CD
Understanding FMLA and ADA

Understanding FMLA and ADA

  • Speaker: Teri Morning
  • Product ID: 703529
  • Duration: 60 Min
This webinar will cover both Family and Medical leave Act (FMLA) and the Americans with Disabilities Act (ADA) federal regulations. It will help attendees understand their responsibilities and rights under these federal laws.
CD/Recorded
$229
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Recorded/CD
Effective Vendor Risk Management

Effective Vendor Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705193
  • Duration: 90 Min
Vendor risk management is an important component of a financial institution’s operational risk management program. This training program will examine how a sound vendor risk management program, including careful planning, due diligence and selection, and close oversight and monitoring during the life of the contract, is necessary to reduce the risks posed by the outsourcing of critical functions.
CD/Recorded
$229
View Details
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