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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
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Preparing for FDA's Unique Device Identification Rule

Preparing for FDA's Unique Device Identification Rule

  • Speaker: Daniel O Leary
  • Product ID: 702594
  • Duration: 90 Min
This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Title 19 Customs Duties Parts 200 to End, Revised

Title 19 Customs Duties Parts 200 to End, Revised

  • Speaker: Suzanne Richer
  • Product ID: 704357
  • Duration: 60 Min
This training program will analyze the customs entry process and AD/CVD (Antidumping and Countervailing). It will also clarify reimbursement statements – what they are and how they work and regulations on AD/CBP/CVD.
CD/Recorded
$0
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Recorded/CD
ISO/IEC 27001:2013 - Breaking It Down to Understand and Implement

ISO/IEC 27001:2013 - Breaking It Down to Understand and Implement

  • Speaker: Michael C Redmond
  • Product ID: 703977
  • Duration: 90 Min
This training program will guide attendees in implementing and complying with the requirements of ISO 27001:2013. ISO 27001 is an international standard published by the International Standardization Organization (ISO), and it describes how to manage information security in a company. The latest revision of this standard was published in 2013, and its full title now is ISO/IEC 27001:2013.
CD/Recorded
$0
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Recorded/CD
Employee Discharge and Documentation: Using Documentation to Control the Employment Relationship

Employee Discharge and Documentation: Using Documentation to Control the Employment Relationship

  • Speaker: Douglas Pilarski
  • Product ID: 704036
  • Duration: 120 Min
This webinar will help managers establish best practices for managing their workforce using sound performance management techniques, especially documentation of poor job performance and code of conduct violations to best support terminations. Learn how HR can coach their executives and managers on how best to work through their performance management strategy.
CD/Recorded
$349
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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
Responding to Unsolicited Requests for Off-Label Information

Responding to Unsolicited Requests for Off-Label Information

  • Speaker: Mukesh Kumar
  • Product ID: 703464
  • Duration: 90 Min
This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.
CD/Recorded
$229
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Recorded/CD
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

  • Speaker: Mukesh Kumar
  • Product ID: 703422
  • Duration: 90 Min
This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
CD/Recorded
$229
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Recorded/CD
CMC Considerations for INDs and NDAs for 505(b)(2) Products

CMC Considerations for INDs and NDAs for 505(b)(2) Products

  • Speaker: Mukesh Kumar
  • Product ID: 703393
  • Duration: 90 Min
This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.
CD/Recorded
$229
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Recorded/CD
Conducting A Thorough Needs Analysis and Developing A Solid Compliance Training Program

Conducting A Thorough Needs Analysis and Developing A Solid Compliance Training Program

  • Speaker: Justin Muscolino
  • Product ID: 706224
  • Duration: 60 Min
Conducting a needs analysis is important since it ultimately feeds into the creation of your compliance training program. The steps you should follow can make a big impact on the program itself and, the compliance culture. In this webinar, we will go over the necessary steps and show how it impacts your compliance training program.
CD/Recorded
$0
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Recorded/CD
Record Keeping for a food Recall: Keeping Records to Minimize the Affect of a Recall

Record Keeping for a food Recall: Keeping Records to Minimize the Affect of a Recall

  • Speaker: Craig Nelson
  • Product ID: 701119
  • Duration: 60 Min
This Food safety training will provide valuable guidance to management, supervision, and quality staff that are involved with record keeping for product and ingredient traceability and recall.
CD/Recorded
$199
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Recorded/CD
Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>

Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>

  • Speaker: Scott Sutton
  • Product ID: 701238
  • Duration: 85 Min
This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.
CD/Recorded
$299
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Recorded/CD
Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness

Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness

  • Speaker: Dr. Susan Strauss
  • Product ID: 706946
  • Duration: 90 Min
Employers are seeing more mental health issues in their workforce than ever before. Long COVID has enhanced mental health concerns even more. Each year 1 in 5 adults is stricken with a mental illness (National Institute of Mental health), making mental illness an everyday reality for many of your employees. Yet only 1 in 3 people seek help with their illness. The ADA, HIPPA, FMLA and most states’ human/civil rights department dictate how employers deal with employees with mental health problems and could charge employers with civil rights liability. Privacy laws create challenges for employers to determine how serious a situation is and whether an employee poses a danger (though those with a mental illness pose no more risk of violence than those without a mental illness). Two thirds of employees would take a pay cut for a job that supports mental health – do you? As a manager, what can you do to better recognize and take care of your employees’ mental health? Seventy percent of employees could do more to support their employees’ mental health according to the Society of Human Rights Management (SHRM, February 15, 2023).
CD/Recorded
$0
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Recorded/CD
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

  • Speaker: Michael Ferrante
  • Product ID: 703538
  • Duration: 90 min
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$249
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Recorded/CD
Record Keeping for the Bioterrorism Act: Meeting and Exceeding the Requirements in a Simple Manner

Record Keeping for the Bioterrorism Act: Meeting and Exceeding the Requirements in a Simple Manner

  • Speaker: Craig Nelson
  • Product ID: 701318
  • Duration: 60 Min
This Bioterrorism act training will provide the attendee a clear understanding of what is expected, how an investigation will proceed, and how to keep records that will minimize the impact of an incident.
CD/Recorded
$299
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Recorded/CD
Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

  • Speaker: Robert J Russell
  • Product ID: 701267
  • Duration: 90 Min
This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$0
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Recorded/CD
Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

  • Speaker: Robert J Russell
  • Product ID: 701260
  • Duration: 60 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$0
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Recorded/CD
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

  • Speaker: Robert J Russell
  • Product ID: 701266
  • Duration: 90 Min
This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.
CD/Recorded
$0
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