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
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

  • Speaker: Saeed Qureshi
  • Product ID: 705271
  • Duration: 120 Min
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
CD/Recorded
$0
Recorded/CD
Sample Quality Control for Molecular Diagnostics

Sample Quality Control for Molecular Diagnostics

  • Speaker: Todd Graham
  • Product ID: 705222
  • Duration: 60 Min
In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratory challenges in clinical laboratory.
CD/Recorded
$299
Recorded/CD
The Provider Self Disclosure Protocol (SDP) and the OIG- Compliance: Self - Reporting to OIG - When should this happen and how to do it?

The Provider Self Disclosure Protocol (SDP) and the OIG- Compliance: Self - Reporting to OIG - When should this happen and how to do it?

  • Speaker: Laura S Hargraves
  • Product ID: 703203
  • Duration: 60 Min
This training on OIG Self-Disclosure Protocol will help the attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting. It will also review the need for the organization to be aware of excluded entities.
CD/Recorded
$249
Recorded/CD
Achieving Success and Compliance in the Supply Chain

Achieving Success and Compliance in the Supply Chain

  • Speaker: Danielle DeLucy
  • Product ID: 705907
  • Duration: 60 Min
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
CD/Recorded
$0
Recorded/CD
Cell Based Assays: Development and Validation

Cell Based Assays: Development and Validation

  • Speaker: Michael Simonian
  • Product ID: 704528
  • Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
CD/Recorded
$0
Recorded/CD
How to Think Like an Accountable Care Organization - Integrating Case Management Across the Continuum

How to Think Like an Accountable Care Organization - Integrating Case Management Across the Continuum

  • Speaker: Toni Cesta
  • Product ID: 705201
  • Duration: 60 Min
This program provides the attendee with concrete and implementable strategies for integrating and embedding case management across the continuum of care.
CD/Recorded
$199
Recorded/CD
How to prepare for a CBP Audit

How to prepare for a CBP Audit

  • Speaker: Raymond Sullivan
  • Product ID: 705352
  • Duration: 60 Min
This CBP audit preparation training program will help attendees move toward a systematic approach for both general compliance and when notified about a CBP audit. It will help identify the likelihood of being subject to CBP audits, and help spot potential vulnerabilities and test your compliance (potential vulnerability, self review and general audit issues).
CD/Recorded
$179
Recorded/CD
Assay Validation for Clinical Diagnostics

Assay Validation for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 702872
  • Duration: 60 Min
This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.
CD/Recorded
$249
Recorded/CD
Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
CD/Recorded
$349
Recorded/CD
Mastering Medicare and Medicaid Marketing Regulations: Do's and Don'ts

Mastering Medicare and Medicaid Marketing Regulations: Do's and Don'ts

  • Speaker: William Mack Copeland
  • Product ID: 705230
  • Duration: 60 Min
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
CD/Recorded
$229
Recorded/CD
Cal/OSHA Enforcement and Defenses - Recent Changes in the Law

Cal/OSHA Enforcement and Defenses - Recent Changes in the Law

  • Speaker: James T. Dufour
  • Product ID: 701977
  • Duration: 90 Min
This webinar on Cal/OSHA Enforcement and Defenses will cover the recent changes in the law, specifically the four most significant developments in Cal/OSHA enforcement and defense that will have an impact in 2015.
CD/Recorded
$199
Recorded/CD
CMS Hospital Improvement Act Proposed Changes: Nursing, Medical Records, Infection Control, Antibiotic Stewardship Program, Restraints, QAPI

CMS Hospital Improvement Act Proposed Changes: Nursing, Medical Records, Infection Control, Antibiotic Stewardship Program, Restraints, QAPI

  • Speaker: Sue Dill Calloway
  • Product ID: 705197
  • Duration: 120 Min
This program is going to cover the proposed changes that CMS wants to make for all hospitals including critical access hospitals. These changes will affect many different departments of the hospital including nursing, QAPI, medical records, lab, restraint standards, discrimination, patient rights, and more.
CD/Recorded
$279
Recorded/CD
The Board of Directors Role in Cybersecurity

The Board of Directors Role in Cybersecurity

  • Speaker: Rayleen M Pirnie
  • Product ID: 705117
  • Duration: 60 Min
This webinar will break down the Board’s role in effective cybersecurity oversight, the 12 questions a board member should be knowing to answer, key principles of oversight, tips and resources for board.
CD/Recorded
$179
Recorded/CD
Title 19 CFR 171 - U.S Customs Prior Disclosure: Mitigate Risks and Avoid Penalties

Title 19 CFR 171 - U.S Customs Prior Disclosure: Mitigate Risks and Avoid Penalties

  • Speaker: Raymond Sullivan
  • Product ID: 704691
  • Duration: 90 Min
This training program will analyze Title 19 CFR 171 - U.S Customs Prior Disclosure. It will objectively evaluate customs errors and mistakes and define the pros and cons of disclosing to customs. The program will further demonstrate the consequences of disclosure or non-disclosure and remedial measures.
CD/Recorded
$199
Recorded/CD
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
CD/Recorded
$249
Recorded/CD
Stability Programs for Leachable Impurities

Stability Programs for Leachable Impurities

  • Speaker: Wayland Rushing
  • Product ID: 704685
  • Duration: 60 Min
This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.
CD/Recorded
$199
Recorded/CD
Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

  • Speaker: Gregory Martin
  • Product ID: 705347
  • Duration: 90 Min
This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.
CD/Recorded
$199
Recorded/CD
Extractables and Leachables in Early Phase Development

Extractables and Leachables in Early Phase Development

  • Speaker: Wayland Rushing
  • Product ID: 704517
  • Duration: 60 Min
This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.
CD/Recorded
$179
Recorded/CD
Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

  • Speaker: Gregory Martin
  • Product ID: 705325
  • Duration: 90 Min
This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.
CD/Recorded
$249
Recorded/CD
Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

  • Speaker: John J Meola
  • Product ID: 705493
  • Duration: 90 Min
This webinar will review the best practices associated with use of ladders of all types, including the selection, inspection, storage and transport of ladders, along with safe practice when erecting, climbing, working from and descending a ladder. It will also discuss the process and practices related with aerial lifts and working from buckets on an extended boom.
CD/Recorded
$179
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