ComplianceOnline
Join for Free
Signin
Welcome back! Please log in below to continue.
Forgot Password?
New customer? Free Signup
Your Shopping Cart
Contains 0 items
Total: $0.00
View Shopping Cart
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!
Loading....
Recorded/CD
HIPAA and Business Associates - New Responsibilities and Obligations

HIPAA and Business Associates - New Responsibilities and Obligations

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702610
  • Duration: 90 Min
HIPAA regulations pertaining to the relationships of business entities that share PHI are now being enforced. HIPAA Business Associates are covered directly under the Privacy Rule’s use and disclosure limitations, the Security Rule’s safeguard provisions, and the Breach Notification Rule’s notification requirements. HIPAA Business Associates are responsible for their own compliance with the regulations, and may be held directly liable for any violations of the regulations. Whether your organization is a Business Associate or a Covered Entity that hires HIPAA Business Associates, you have significant obligations in compliance that you overlook at your peril.
CD/Recorded
$249
View Details
Recorded/CD
Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention

Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention

  • Speaker: Dr. Susan Strauss
  • Product ID: 704876
  • Duration: 60 Min
Unconscious bias has been recognized as a form of discrimination and can therefore lead to lawsuits. This training program addresses the science of unconscious bias and lists the examples and types. The Instructor will discuss the implicit association test (IAT) and steps to minimize individual and organizational unconscious bias in hiring, promotions, and retention.
CD/Recorded
$249
View Details
Recorded/CD
DEA, Your Registration and How to Lose It

DEA, Your Registration and How to Lose It

  • Speaker: Carlos M Aquino
  • Product ID: 701992
  • Duration: 120 Min
This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.
CD/Recorded
$299
View Details
Recorded/CD
Travel and Expense Policy Development and Automation

Travel and Expense Policy Development and Automation

  • Speaker: Brian G Rosenberg
  • Product ID: 704880
  • Duration: 60 Min
In this webinar training, you will learn how to create, maintain, and enforce a T&E policy for your organization. The Instructors will discuss the key components and best practices for policies.
CD/Recorded
$199
View Details
Recorded/CD
Compliance Measures for Case Managers

Compliance Measures for Case Managers

  • Speaker: Toni Cesta
  • Product ID: 705318
  • Duration: 60 Min
This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.
CD/Recorded
$229
View Details
Recorded/CD
Measurement Uncertainty in Microbiology

Measurement Uncertainty in Microbiology

  • Speaker: Michael Brodsky
  • Product ID: 703902
  • Duration: 60 Min
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
CD/Recorded
$179
View Details
Recorded/CD
INCOTERMS - International Commercial Terms

INCOTERMS - International Commercial Terms

  • Speaker: John Dunlop
  • Product ID: 702213
  • Duration: 60 Min
This 60-minute webinar will help exporters understand International Commercial Terms, or INCOTERMs, published by the International Chamber of Commerce and how to select the correct one for their transactions.
CD/Recorded
$229
View Details
Recorded/CD
Handling OOS Test Results and Completing Robust Investigations

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
CD/Recorded
$299
View Details
Recorded/CD
Requirements for Running Clinical Trials in Pediatrics for the EU

Requirements for Running Clinical Trials in Pediatrics for the EU

  • Speaker: Laura Brown
  • Product ID: 701983
  • Duration: 60 Min
This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.
CD/Recorded
$299
View Details
Recorded/CD
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
CD/Recorded
$249
View Details
Recorded/CD
Integrating COBIT with COSO and Other Frameworks

Integrating COBIT with COSO and Other Frameworks

  • Speaker: Robert Davis
  • Product ID: 702567
  • Duration: 60 Min
Dr. Davis describes important directions and core principles of selected frameworks. He also links these guidelines and principles to relevant practices. The principles outlined in this session reflect ISACA defined governance system themes: (1) meeting stakeholder needs (2) enterprise end-to-end coverage, (3) organizational customization (4) dynamic homeostasis, (5) enabling a holistic approach, and (6) separating governance from management.
CD/Recorded
$149
View Details
Recorded/CD
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

  • Speaker: Joy McElroy
  • Product ID: 704086
  • Duration: 120 Min
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
CD/Recorded
$249
View Details
Recorded/CD
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

  • Speaker: Laura Brown
  • Product ID: 701947
  • Duration: 60 Min
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
CD/Recorded
$299
View Details
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$199
View Details
Recorded/CD
Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705220
  • Duration: 90 Min
This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
CD/Recorded
$199
View Details
Recorded/CD
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Speaker: John E Lincoln
  • Product ID: 701898
  • Duration: 90 Min
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
CD/Recorded
$199
View Details
Recorded/CD
ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

  • Speaker: Betty Lane
  • Product ID: 702871
  • Duration: 60 Min
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
CD/Recorded
$199
View Details
Recorded/CD
Quality Control of Microbiological Media, Reagents and Test Kits

Quality Control of Microbiological Media, Reagents and Test Kits

  • Speaker: Michael Brodsky
  • Product ID: 703599
  • Duration: 60 Min
The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
CD/Recorded
$169
View Details
Recorded/CD
Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
CD/Recorded
$189
View Details
Recorded/CD
QA Agreements for ISO 13485:2019 and other Regulatory Compliance

QA Agreements for ISO 13485:2019 and other Regulatory Compliance

  • Speaker: Betty Lane
  • Product ID: 703515
  • Duration: 60 Min
In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.
CD/Recorded
$189
View Details
Best Sellers
You Recently Viewed
    Loading
Copyright © 2025 ComplianceOnline.com
MetricStream
Our Policies: Terms of use | Privacy