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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
Understanding and Implementing a Technology Transfer Process

Understanding and Implementing a Technology Transfer Process

  • Speaker: Steven Laurenz
  • Product ID: 705031
  • Duration: 60 Min
This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
CD/Recorded
$299
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Recorded/CD
Objectionable Microorganisms in Biopharmaceutical Manufacturing

Objectionable Microorganisms in Biopharmaceutical Manufacturing

  • Speaker: Carl Patterson
  • Product ID: 705319
  • Duration: 60 Min
This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.
CD/Recorded
$249
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Recorded/CD
Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
CD/Recorded
$299
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Recorded/CD
Validation of GC / GC-MS Methodologies

Validation of GC / GC-MS Methodologies

  • Speaker: John Fetzer
  • Product ID: 705259
  • Duration: 60 Min
This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.
CD/Recorded
$199
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Recorded/CD
Stress-Testing in Financial Institutions: Selecting Appropriate Scenarios

Stress-Testing in Financial Institutions: Selecting Appropriate Scenarios

  • Speaker: Fred Vacelet
  • Product ID: 705249
  • Duration: 60 Min
This webinar training on stress testing in financial institutions will depict scenarios, pitfalls to be avoided, and discuss how the choice of the right scenarios can provide good insight into strategic management of a financial institution.
CD/Recorded
$229
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Recorded/CD
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

  • Speaker: Robert J Russell
  • Product ID: 702038
  • Duration: 90 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
CD/Recorded
$299
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Recorded/CD
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
CD/Recorded
$299
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Recorded/CD
Analytical Method Validation Under Good Laboratory Practices (GLPs)

Analytical Method Validation Under Good Laboratory Practices (GLPs)

  • Speaker: John Fetzer
  • Product ID: 703561
  • Duration: 60 Min
This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
CD/Recorded
$219
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Recorded/CD
Understanding the FDA Compounding Pharmacies Guidance

Understanding the FDA Compounding Pharmacies Guidance

  • Speaker: Carl Patterson
  • Product ID: 705348
  • Duration: 60 Min
This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
CD/Recorded
$229
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Recorded/CD
Exempt Employees: Taking the Guess Work out of Identifying and Paying Them in 2020

Exempt Employees: Taking the Guess Work out of Identifying and Paying Them in 2020

  • Speaker: Vicki M. Lambert
  • Product ID: 704126
  • Duration: 90 Min
This training program will discuss the four classification of exempt employees permitted under the IRS code including executive, administrative, professional and outside sales. It will examine the salary level test and the salary basis test.
CD/Recorded
$249
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Recorded/CD
Dealing with the Disruptive Practitioner in a Legally Compliant Manner

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.
CD/Recorded
$229
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Recorded/CD
Understanding and Implementing a Quality by Design (QbD) Program

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
CD/Recorded
$299
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Recorded/CD
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

  • Speaker: Robert J Russell
  • Product ID: 705370
  • Duration: 90 Min
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
CD/Recorded
$299
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Recorded/CD
Challenges, Opportunities and Compliance Requirements for Same Day ACH (SDA)

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.
CD/Recorded
$179
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Recorded/CD
How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability

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.
CD/Recorded
$229
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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
Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

  • Speaker: Michael Brodsky
  • Product ID: 705272
  • Duration: 60 Min
This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.
CD/Recorded
$199
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Recorded/CD
Generational Divide: What's Behind Generational Differences in the Workplace?

Generational Divide: What's Behind Generational Differences in the Workplace?

  • Speaker: Mary Gormandy White
  • Product ID: 704362
  • Duration: 60 Min
In this training program, participants will learn how and why the generations differ in terms of how they approach work - focused on understanding the unique perspectives, contributions and value of each generation. Supervisors will also learn practical best practice tips and suggestions they can apply to effectively manage employees outside their own generation - both older and younger.
CD/Recorded
$199
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Recorded/CD
Mastering U.S. Export Administration Regulations

Mastering U.S. Export Administration Regulations

  • Speaker: Jo-Anne Daniels
  • Product ID: 700398
  • Duration: 60 Min
This U.S. Export Administration Regulations webinar training will give attendees the tools to assess potential gaps in your company’s export controls/compliance program
CD/Recorded
$149
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Recorded/CD
Where FDA Is Heading in Regulating Laboratory-Developed Tests

Where FDA Is Heading in Regulating Laboratory-Developed Tests

  • Speaker: Dennis Weissman
  • Product ID: 705335
  • Duration: 60 Min
The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.
CD/Recorded
$219
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