ComplianceOnline

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!

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
$189
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
$0
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
$169
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
$0
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
$159
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
$169
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
$149
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
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
$199
Recorded/CD
Essentials of OFCCP Compliance: Requirement, Enforcement and Fulfilment of Affirmative Action

Essentials of OFCCP Compliance: Requirement, Enforcement and Fulfilment of Affirmative Action

  • Speaker: Janette Levey Frisch
  • Product ID: 705199
  • Duration: 90 Min
If you are a federal contractor, having a firm grasp on the essentials of affirmative action and OFCCP compliance is a must, whether you are new to the federal contracting world or a seasoned contractor. This webinar training program will offer attendees an understanding of affirmative action laws and regulations enforced by the OFCCP. It will also discuss Affirmative Action Plans for women and minorities, and for disabled and veteran workers.
CD/Recorded
$179
Recorded/CD
SOP's for Bioanalytical Methods Validation

SOP's for Bioanalytical Methods Validation

  • Speaker: Todd Graham
  • Product ID: 704916
  • Duration: 60 Min
This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.
CD/Recorded
$0
Recorded/CD
Confidentiality of Substance Use Disorder Patient Records; Complying with the New Federal Law 42 CFR Part 2

Confidentiality of Substance Use Disorder Patient Records; Complying with the New Federal Law 42 CFR Part 2

  • Speaker: Sue Dill Calloway
  • Product ID: 705254
  • Duration: 120 Min
This webinar will cover the new law on confidentiality of substance use disorder patient records under 42 CFR part 2. This law was previously known as the confidentiality of drug abuse and alcohol abuse records. The new law was effective in 2017. Anyone or any facility that is subject to these requirements needs to attend this webinar.
CD/Recorded
$229
Recorded/CD
OTC Drug Regulations

OTC Drug Regulations

  • Speaker: Loren Gelber
  • Product ID: 705446
  • Duration: 60 Min
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
CD/Recorded
$179
Recorded/CD
How Medicare's Market-Based Payment System Is Upending the U.S. Clinical Laboratory Market

How Medicare's Market-Based Payment System Is Upending the U.S. Clinical Laboratory Market

  • Speaker: Dennis Weissman
  • Product ID: 705232
  • Duration: 90 Min
This online training will cover PAMA mandates, CMS regulatory requirements, guidance and related government reports on implementing Medicare market-based Payment Methodology for laboratory services.
CD/Recorded
$179
Recorded/CD
Learn or Refresh Your HTS Classification & NAFTA Skills

Learn or Refresh Your HTS Classification & NAFTA Skills

  • Speaker: Jo-Anne Daniels
  • Product ID: 700694
  • Duration: 60 Min
Classification understanding is the foundation of an Import Management System.
CD/Recorded
$199
Recorded/CD
Import-Export 101 for Business Professionals

Import-Export 101 for Business Professionals

  • Speaker: Douglas Cohen
  • Product ID: 704776
  • Duration: 60 Min
This webinar will prepare business professionals to deal with issues such as how to find buyers, customers, or suppliers, import-export documentation, transport cost and duties, international trade regulations, and how to get paid.
CD/Recorded
$159
Recorded/CD
Is Your Compliance Program Due for an Update?

Is Your Compliance Program Due for an Update?

  • Speaker: Jim Kandler
  • Product ID: 705085
  • Duration: 60 Min
This training program will highlight common issues that occur over time with material compliance programs, and demonstrate how to address them. This can result in a more effective and responsive material compliance effort for your company.
CD/Recorded
$169
Recorded/CD
Supplemental Pay Essentials - Severance Pay, Deferred Compensation, Recordkeeping and Fringe Benefits

Supplemental Pay Essentials - Severance Pay, Deferred Compensation, Recordkeeping and Fringe Benefits

  • Speaker: Patrick A Haggerty
  • Product ID: 704112
  • Duration: 90 Min
This training program will help attendees distinguish between supplemental wage payments and regular wage payments and help them identify wage payments that are neither supplemental nor regular. It will also detail methods used to compute withholding on supplemental pay including examples.
CD/Recorded
$189
Recorded/CD
How to Survive CBP Free Trade Agreement Verification

How to Survive CBP Free Trade Agreement Verification

  • Speaker: Donna L Shira
  • Product ID: 703258
  • Duration: 60 Min
This U.S. Customs & Border Protection (CBP) compliance training will provide attendees tools to ensure they comply with rules and regulations applicable to Free Trade Agreement (FTA) and special trade program claims.
CD/Recorded
$199
Recorded/CD
How to Prepare a Customs Compliance Manual

How to Prepare a Customs Compliance Manual

  • Speaker: Donna L Shira
  • Product ID: 703319
  • Duration: 60 Min
This webinar will explain how to prepare a Customs manual that complies with CBP laws and regulations. Attendees will learn best practices for successfully passing an audit or becoming an Importer Self Assessment Program (ISA) member.
CD/Recorded
$149
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