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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
Improving Sanitation Standard Operating Procedures In the Food Industry

Improving Sanitation Standard Operating Procedures In the Food Industry

  • Speaker: Angeline Benjamin
  • Product ID: 701642
  • Duration: 60 Min
In this Food Safety training learn how to create and implement a sanitation SOP to avoid failure of the HACCP system.
CD/Recorded
$229
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Recorded/CD
The Evolving State of U.S Sanctions Against Iran

The Evolving State of U.S Sanctions Against Iran

  • Speaker: Erich C. Ferrari
  • Product ID: 704021
  • Duration: 60 Min
This training program will offer attendees an understanding of U.S. sanctions targeting Iran, varying compliance obligations, and OFAC’s licensing policies. It will also discuss remaining Iran sanctions compliance obligations.
CD/Recorded
$149
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Recorded/CD
Affordable Care Act Update and Outlook for 2016 and Beyond

Affordable Care Act Update and Outlook for 2016 and Beyond

  • Speaker: Frederick L Pilot
  • Product ID: 704020
  • Duration: 70 Min
This training program will provide attendees with an excellent understanding of the status of the ACA’s health insurance market reforms, associated implementation challenges and emerging issues to inform their strategy and policymaking.
CD/Recorded
$179
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Recorded/CD
Lyophilization Technology

Lyophilization Technology

  • Speaker: Jerry Dalfors
  • Product ID: 704028
  • Duration: 80 Min
This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.
CD/Recorded
$229
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Recorded/CD
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

  • Speaker: Mukesh Kumar
  • Product ID: 703652
  • Duration: 90 Min
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
CD/Recorded
$229
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Recorded/CD
How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

  • Speaker: David Lim
  • Product ID: 703245
  • Duration: 60 Min
This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.
CD/Recorded
$229
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Recorded/CD
Good Documentation Practices (GDP)

Good Documentation Practices (GDP)

  • Speaker: Alla Teresh
  • Product ID: 703874
  • Duration: 60 Min
This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
CD/Recorded
$229
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Recorded/CD
Payroll Record Keeping: Who Requires What, for How Long and in What Format

Payroll Record Keeping: Who Requires What, for How Long and in What Format

  • Speaker: Diana Chomichuk
  • Product ID: 703755
  • Duration: 60 Min
Personnel records are documentation of an individual's employment history encompassing all employment-related information collected and maintained by the employer. These essential documents form the foundation upon which employment actions are based. This webinar will illustrate key concepts in managing personnel records to protect your organization from potential exposure and security threats.
CD/Recorded
$149
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Recorded/CD
Affordable Care Act Updates: What Employers Need to do to Prepare

Affordable Care Act Updates: What Employers Need to do to Prepare

  • Speaker: Vanessa G Nelson
  • Product ID: 703753
  • Duration: 60 Min
For HR representatives and business owners of mid and large sized enterprises, this course will elaborate current trends and updates on the Affordable Care Act. It will emphasize the need for compliance with these updates and list ACA penalties for non-compliance.
CD/Recorded
$149
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Recorded/CD
Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703879
  • Duration: 90 Min
This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.
CD/Recorded
$229
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Recorded/CD
Veterinary Drug Approval Process and FDA's Regulatory Oversight

Veterinary Drug Approval Process and FDA's Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703971
  • Duration: 60 Min
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
CD/Recorded
$0
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Recorded/CD
Be Ready for eMDR Going Live August 14, 2015

Be Ready for eMDR Going Live August 14, 2015

  • Speaker: Rita Hoffman
  • Product ID: 703972
  • Duration: 110 Min
This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).
CD/Recorded
$249
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Recorded/CD
Country of Origin Marking on U.S. Imports

Country of Origin Marking on U.S. Imports

  • Speaker: Jan Seal
  • Product ID: 701909
  • Duration: 90 Min
Understand the regulations applied to most goods imported into the United States and the U.S. marking regulations to follow before exporting goods into the U.S.
CD/Recorded
$149
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Recorded/CD
Preparing Effective Policies and Handbooks

Preparing Effective Policies and Handbooks

  • Speaker: Gayla Sherry
  • Product ID: 703196
  • Duration: 60 Min
The webinar will discuss why policies and handbooks are important and strategies for developing or updating your policies and handbooks. You will be provided with tools for determining the laws that are applicable to your company and resources for developing an employee handbook.
CD/Recorded
$149
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Recorded/CD
Preparing for and Managing FDA Inspections

Preparing for and Managing FDA Inspections

  • Speaker: Jonathan M Lewis
  • Product ID: 703512
  • Duration: 90 Min
This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.
CD/Recorded
$279
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Recorded/CD
2015 OFAC Sanction, Related Export Control Violations and Enforcement Trends: Best Practices for Preventing Violations

2015 OFAC Sanction, Related Export Control Violations and Enforcement Trends: Best Practices for Preventing Violations

  • Speaker: Robert J Ward Jr
  • Product ID: 703919
  • Duration: 90 Min
This training program will update participants on the developments regarding OFAC sanctions, OFAC enforcement trends as well as related export control traps for the unwary. The discussion of OFAC sanction developments will give participants an appreciation of the new war chest of punitive measures being deployed in recent executive orders.
CD/Recorded
$50
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Recorded/CD
India's Import-Export Policy and Procedures - Best Practices and Risks

India's Import-Export Policy and Procedures - Best Practices and Risks

  • Speaker: Deep SenGupta
  • Product ID: 703968
  • Duration: 90 Min
This training program will discuss the historical context of India's current trade policy and overview India's commercial climate and market access issues. The course will also highlight top import and export compliance errors, and strategies for smooth trade facilitation into and out of India.
CD/Recorded
$149
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Recorded/CD
Letters of Credit, OFAC, Antiboycott and AML Regulations for Trade Service Bankers

Letters of Credit, OFAC, Antiboycott and AML Regulations for Trade Service Bankers

  • Speaker: Buddy Baker
  • Product ID: 703967
  • Duration: 90 Min
This training program will provide participants with an essential, basic understanding of U.S. rules and regulations governing international trade. The regulations contain required (and prohibited) business conduct, with penalties for failure to comply including fines, loss of export privileges, and even jail terms. In many cases, banks are required to police transactions they handle and report violations.
CD/Recorded
$149
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Recorded/CD
Importing Pharmaceutical Products: What Every Importer of Drugs and APIs Should Know

Importing Pharmaceutical Products: What Every Importer of Drugs and APIs Should Know

  • Speaker: Reynaldo Roman
  • Product ID: 703960
  • Duration: 90 Min
This training program will focus on U.S. import entry compliance and FDA import entry compliance. U.S. import requirements for pharmaceutical products are among the most rigorous of any country. As a result, it is critical for importers of drugs and APIs to know and comply with these requirements. Failure to comply with U.S. import requirements may result in clearance delays or import shipments being refused entry into the U.S.
CD/Recorded
$229
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Recorded/CD
Making the Move to ISO 27001: 2013

Making the Move to ISO 27001: 2013

  • Speaker: Mike Popham
  • Product ID: 703959
  • Duration: 90 Min
This training program will discuss what to present to management to exploit – as an opportunity - transitioning to ISO 27001: 2013. It will also detail how to prepare, the assistance available, and what tools exist to inform a justification based on efficiency, awareness and market gains. Getting top management buy-in, which may require hiring a consultant and getting people trained can be barriers to success in sustaining a standards-informed approach to business, no less than for a mandatory management system update that will require funding and, therefore, justification.
CD/Recorded
$149
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