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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Hundreds of regulatory affairs specialists each year use ComplianceOnline courses to learn skills and get a clear understanding of specific regulatory requirements needed to succeed in their role. On this page, you will find a broad range of courses specially designed for you. Whether you work in the pharmaceutical, medical device, and equipment, biotechnology, cosmetics, research, or regulatory agencies, or within legal, marketing, and scientific consulting firms, you can get acquainted with the regulatory requirements and guidance for your industry. With the knowledge you gain, you will learn how to apply the regulations in a compliant manner into the actual materials that your company manufactures. You will be in a better position to understand the risks your organization faces. You will get a robust understanding of compliance within the scope of your duties. With the knowledge you gain, you can evaluate current practices and make improvements where necessary. Join them!
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Recorded/CD
Import and Export - Improving Your International Trade Compliance Score

Import and Export - Improving Your International Trade Compliance Score

  • Speaker: Deep SenGupta
  • Product ID: 703961
  • Duration: 60 Min
This international trade compliance training program will evaluate strategies such as drawback, foreign trade zones or free trade agreements. It will also offer guidance and best practice strategies for several import/export practices such as methodology for measuring trade compliance score, and determining export control classification number.
CD/Recorded
$349
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Recorded/CD
Successful 510(k) Submissions

Successful 510(k) Submissions

  • Speaker: John E Lincoln
  • Product ID: 700815
  • Duration: 60 Min
In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
CD/Recorded
$399
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Recorded/CD
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
CD/Recorded
$299
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Recorded/CD
Prevention of Infection in Healthcare Workers

Prevention of Infection in Healthcare Workers

  • Speaker: David Woodard
  • Product ID: 703636
  • Duration: 60 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.
CD/Recorded
$199
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Recorded/CD
Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success

  • Speaker: Meena Chettiar
  • Product ID: 705400
  • Duration: 60 Min
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
CD/Recorded
$0
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Recorded/CD
Beyond Handbooks, Benefits, and Photo IDs: The Role of HR and Management in New Employee Onboarding

Beyond Handbooks, Benefits, and Photo IDs: The Role of HR and Management in New Employee Onboarding

  • Speaker: Dr. Susan Strauss
  • Product ID: 704627
  • Duration: 90 Min
This training program will discuss a new employee’s role in his/her orientation and difference between orientation to the organization and orientation to the department. The program will also explain gap analysis, force field analysis, and SWOT analysis in assessing your organization’s onboarding requirements.
CD/Recorded
$229
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Recorded/CD
US Import: How to prepare for a Customs Audit

US Import: How to prepare for a Customs Audit

  • Speaker: Deep SenGupta
  • Product ID: 703612
  • Duration: 60 Min
This webinar will explain the structure and timeline of a customs audit, and teach attendees how to successfully prepare for an audit. Attendees will learn the best practices for trade compliance and customs compliance that you can implement while importing/exporting to minimize penalties. Also you will learn how to establish a reasonable care process, identify the characteristic of internal controls along-with real life examples of implementing a compliance program successfully.
CD/Recorded
$349
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Recorded/CD
NAFTA: Understanding the Rules of Origin and Certificate of Origin Requirements

NAFTA: Understanding the Rules of Origin and Certificate of Origin Requirements

  • Speaker: Douglas Cohen
  • Product ID: 703168
  • Duration: 60 Min
This training on trade compliance will help the attendees understand the rules to qualify your imports/exports between United States, Mexico, and Canada. You will also learn best practices on how to complete the NAFTA certificate of origin to avoid penalties.
CD/Recorded
$229
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Recorded/CD
The Business Case for LGBT Inclusion in the Workplace: Navigating Policies, Procedures, Practices and Bathrooms

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.
CD/Recorded
$229
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Recorded/CD
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

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.
CD/Recorded
$229
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Recorded/CD
Understanding FDA Design Verification and Validation Requirements for Medical Devices

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.
CD/Recorded
$199
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Recorded/CD
Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

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.
CD/Recorded
$349
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Recorded/CD
Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

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.
CD/Recorded
$189
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Recorded/CD
How to Think Like a Crook - Money Laundering Prevention

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.
CD/Recorded
$199
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Recorded/CD
Validation of HPLC/UPLC Methodologies

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.
CD/Recorded
$219
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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
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Recorded/CD
FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

  • Speaker: Carolyn Troiano
  • Product ID: 705097
  • Duration: 90 Min
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
CD/Recorded
$299
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Recorded/CD
Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 90 Min
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
CD/Recorded
$179
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Recorded/CD
The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

  • Speaker: John Fetzer
  • Product ID: 705292
  • Duration: 60 Min
This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.
CD/Recorded
$199
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Recorded/CD
SOX: Internal Controls for Accounts Payable

SOX: Internal Controls for Accounts Payable

  • Speaker: Mike Morley
  • Product ID: 700323
  • Duration: 60 Min
This Internal Controls for Accounts Payable webinar will provide you with the tools you need to establish and maintain strong internal controls in the A/P department that meet Sarbanes-Oxley standards.
CD/Recorded
$229
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