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
IT Governance and Controls for FDA & SOX compliance: The single solution

IT Governance and Controls for FDA & SOX compliance: The single solution

  • Speaker: James Robertson
  • Product ID: 700188
  • Duration: 60 Min
How a common COBIT-based IT control solution can satisfy multiple regulatory and business requirements. This seminar will show you that a common IT control solution should be available to satisfy multiple regulatory and business requirements.
CD/Recorded
$249
View Details
Recorded/CD
Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits

Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits

  • Speaker: Alyssa Martin
  • Product ID: 700189
  • Duration: 60 Min
This SAS 70 training will provide a Process of SAS 70 Audit, frequency & formatting of documenting controls in COSO and COBIT and SAS 70 Report types and impact of Sarbanes-Oxley to create the demand for SAS 70 audits.
CD/Recorded
$249
View Details
Recorded/CD
Radiation Dose Setting - Method 1

Radiation Dose Setting - Method 1

  • Speaker: Joyce Hansen
  • Product ID: 700119
  • Duration: 60 Min
The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method. This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.
CD/Recorded
$249
View Details
Recorded/CD
A Review of Sarbanes-Oxley's Impact on IT in Year Three

A Review of Sarbanes-Oxley's Impact on IT in Year Three

  • Speaker: George Spafford
  • Product ID: 700111
  • Duration: 60 Min
This SOX compliance training will benefit public companies who are either embarking on their Sarbanes-Oxley compliance journey or are struggling with sustaining their current control environment.
CD/Recorded
$249
View Details
Recorded/CD
Leveraging best-practice frameworks to simplify regulatory compliance

Leveraging best-practice frameworks to simplify regulatory compliance

  • Speaker: Alan Calder
  • Product ID: 700102
  • Duration: 60 Min
This regulatory compliance training will help in frame working and Leveraging best-practices in the way of the business in a cost effective manner. Organizations face complex and rapidly evolving regulatory requirements, which have to be met within an equally fast-changing information threat environment.
CD/Recorded
$249
View Details
Recorded/CD
Reduce the cost of Sarbanes Oxley Compliance using Control Automation

Reduce the cost of Sarbanes Oxley Compliance using Control Automation

  • Speaker: Arthur Stewart
  • Product ID: 700068
  • Duration: 60 Min
This Sarbanes Oxley Compliance (SOX) training is targeted at compliance and risk managers who are looking to leverage leading technology to increase quality and reduce the costs of compliance and process management.
CD/Recorded
$199
View Details
Recorded/CD
Impact of Recent Immigration Developments on Employers

Impact of Recent Immigration Developments on Employers

  • Speaker: Sameer Khedekar
  • Product ID: 705344
  • Duration:
Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.
CD/Recorded
$0
View Details
Recorded/CD
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration:
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
CD/Recorded
$0
View Details
Recorded/CD
Current Regulatory Requirements for Sterile Products

Current Regulatory Requirements for Sterile Products

  • Speaker: Kenneth Christie
  • Product ID: 703672
  • Duration:
This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.
CD/Recorded
$0
View Details
Recorded/CD
The Regulatory Expectations for Environmental Monitoring Programs

The Regulatory Expectations for Environmental Monitoring Programs

  • Speaker: Kenneth Christie
  • Product ID: 703648
  • Duration:
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.
CD/Recorded
$0
View Details
Recorded/CD
Challenges of an Effective Change Control Program

Challenges of an Effective Change Control Program

  • Speaker: Kenneth Christie
  • Product ID: 704638
  • Duration:
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
CD/Recorded
$0
View Details
Recorded/CD
Auditing Business Continuity Plans According to ISO 22301

Auditing Business Continuity Plans According to ISO 22301

  • Speaker: Michael C Redmond
  • Product ID: 704410
  • Duration:

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.
CD/Recorded
$0
View Details
Recorded/CD
Basic Requirements for IQ, OQ and PQ Protocols

Basic Requirements for IQ, OQ and PQ Protocols

  • Speaker: Kenneth Christie
  • Product ID: 704591
  • Duration:
This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
CD/Recorded
$0
View Details
Recorded/CD
4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

  • Speaker: Nanda Subbarao
  • Product ID: 704730
  • Duration:
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.
CD/Recorded
$0
View Details
Recorded/CD
Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

  • Speaker: Kim Huynh-Ba
  • Product ID: 704421
  • Duration:
This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.
CD/Recorded
$0
View Details
Recorded/CD
Annual Analytical Laboratory Data Integrity Training

Annual Analytical Laboratory Data Integrity Training

  • Speaker: Nanda Subbarao
  • Product ID: 705326
  • Duration:
This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.
CD/Recorded
$0
View Details
Recorded/CD
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

  • Speaker: Kim Huynh-Ba
  • Product ID: 703278
  • Duration:
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
CD/Recorded
$0
View Details
Recorded/CD
How to Buy COTS Software, and Audit and Validate Vendors

How to Buy COTS Software, and Audit and Validate Vendors

  • Speaker: David Nettleton
  • Product ID: 703820
  • Duration:
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
CD/Recorded
$0
View Details
Recorded/CD
GMP Requirements for Validation and Re-Validation of Analytical Procedures

GMP Requirements for Validation and Re-Validation of Analytical Procedures

  • Speaker: Kim Huynh-Ba
  • Product ID: 703041
  • Duration:
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
CD/Recorded
$0
View Details
Recorded/CD
Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

  • Speaker: Barry A Friedman
  • Product ID: 705452
  • Duration:
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
CD/Recorded
$0
View Details
Best Sellers
You Recently Viewed
    Loading
Copyright © 2025 ComplianceOnline.com
MetricStream
Our Policies: Terms of use | Privacy