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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
Tests for Outliers

Tests for Outliers

  • Speaker: Steven Wachs
  • Product ID: 704404
  • Duration: 60 Min
This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.
CD/Recorded
$249
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Recorded/CD
Good Deviation Practice: What You Need to Know

Good Deviation Practice: What You Need to Know

  • Speaker: John R Godshalk
  • Product ID: 705293
  • Duration: 60 Min
This webinar explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.
CD/Recorded
$229
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Recorded/CD
The IRS Audit Process - Preparing for and Resolving an Audit Decoding the IRS Audit Process

The IRS Audit Process - Preparing for and Resolving an Audit Decoding the IRS Audit Process

  • Speaker: Travis A Greaves,T Joshua Wu
  • Product ID: 705154
  • Duration: 60 Min
Both clients and tax advisors should be aware of the IRS audit process. This webinar will introduce advisors and clients to factors the IRS considers in selecting an individual for audit, how the IRS obtains information during the audit, and provides you the tools needed to represent the client through IRS appeals.
CD/Recorded
$0
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Recorded/CD
Process Validation - Current Industry Practices and FDA Guidance Document Review

Process Validation - Current Industry Practices and FDA Guidance Document Review

  • Speaker: John R Godshalk
  • Product ID: 705316
  • Duration: 60 Min
This webinar will cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.
CD/Recorded
$249
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Recorded/CD
Post Market Surveillance for Medical Devices

Post Market Surveillance for Medical Devices

  • Speaker: Daniel O Leary
  • Product ID: 702377
  • Duration: 90 Min
This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.
CD/Recorded
$199
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Recorded/CD
Cardiology E/M Coding: Hospital and Office Documentation Compliance

Cardiology E/M Coding: Hospital and Office Documentation Compliance

  • Speaker: Terry Fletcher
  • Product ID: 705312
  • Duration: 60 Min
This webinar will address coding along with billing and payments for the evaluation and management (E/M) services for the cardiology specialty. It will also cover reimbursement issues and best practices to maximize reimbursement opportunities.
CD/Recorded
$0
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Recorded/CD
New Home Health Conditions of Participation

New Home Health Conditions of Participation

  • Speaker: Sharon Litwin
  • Product ID: 705337
  • Duration: 90 Min
This CMS compliance training will address the key changes in the new Conditions of Participations (CoPs) that will be effective July 13, 2017. It will focus on the change processes and policies for patient rights, aide services, evolving plan of care, infection control, emergency preparedness program, QAPI and more.
CD/Recorded
$0
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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: 703650
  • Duration: 60 Min
The course will instruct attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting.
CD/Recorded
$229
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Recorded/CD
Personal Protective Equipment for Scientific and Construction Operations

Personal Protective Equipment for Scientific and Construction Operations

  • Speaker: Keith Warwick
  • Product ID: 705313
  • Duration: 60 Min
This course will describe how to develop a job hazard analysis to address chemical hazards and develop controls to protect workers. It will emphasize the need for PPE (personal protective equipment) training and address the appropriate PPE gear to protect construction workers and to use in laboratories.
CD/Recorded
$0
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Recorded/CD
Drug Pharmacy Compounding

Drug Pharmacy Compounding

  • Speaker: Rachelle D Souza
  • Product ID: 704907
  • Duration: 60 Min
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
CD/Recorded
$249
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Recorded/CD
The New OFAC - OFSI?: Iran Financial Sanctions, Guidance & Many More

The New OFAC - OFSI?: Iran Financial Sanctions, Guidance & Many More

  • Speaker: Shaun Miller
  • Product ID: 705160
  • Duration: 90 Min
This training program will examine the process for imposing monetary penalties for breaches of financial sanctions. It will also deconstruct the process for imposing monetary penalties for breaches of financial sanctions: consultation, operating within counter-terrorism legislation.
CD/Recorded
$0
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Recorded/CD
Pharmaceutical Packaging - Regulations and Testing Standards

Pharmaceutical Packaging - Regulations and Testing Standards

  • Speaker: Thomas Feinberg
  • Product ID: 705305
  • Duration: 90 Min
This webinar will present the current state of US and EU (pre-Brexit) regulatory policy with some insights into the CFDA (China) related to pharmaceutical packaging and testing. A unified risk assessment strategy will be presented to guide laboratory and eventual regulatory reporting activities.
CD/Recorded
$0
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Recorded/CD
ICH Q11 - API Manufacturing

ICH Q11 - API Manufacturing

  • Speaker: Peggy Berry
  • Product ID: 705303
  • Duration: 90 Min
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.
CD/Recorded
$0
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Recorded/CD
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

  • Speaker: John R Godshalk
  • Product ID: 704841
  • Duration: 60 Min
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
CD/Recorded
$349
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Recorded/CD
Impact and Control of RFIs on Construction Projects

Impact and Control of RFIs on Construction Projects

  • Speaker: Jim Zack
  • Product ID: 704288
  • Duration: 90 Min
This webinar discusses the genesis of RFIs and their development and the use and abuse of RFIs on construction projects including ways to mitigate the potential adverse impact of RFIs. Speaker discusses a number of contractual mechanisms to control the RFI process and mitigate potential impact damage claims based on the number of RFIs. The webinar also sets forth best management practices concerning the RFI process.
CD/Recorded
$199
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Recorded/CD
The IRS is Coming: How to Prepare for the New IRS Partnership Audit Rules

The IRS is Coming: How to Prepare for the New IRS Partnership Audit Rules

  • Speaker: Travis A Greaves,T Joshua Wu
  • Product ID: 705112
  • Duration: 60 Min
The new IRS partnership audit rules require all partnership and LLCs taxed as partnerships to amend their partnership agreement and take action now. In this training program, attendees will learn how these rules impact your business and your clients. The session will discuss IRS issues with TEFRA (Tax Equity and Fiscal Responsibility Act) and detail the concepts and terms in the Bipartisan Budget Act.
CD/Recorded
$0
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Recorded/CD
Three Ways Home Healthcare is Changing the Medical Device Game

Three Ways Home Healthcare is Changing the Medical Device Game

  • Speaker: Tom Kramer
  • Product ID: 705228
  • Duration: 60 Min
This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.
CD/Recorded
$0
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Recorded/CD
HIPAA and the Compliance Officer

HIPAA and the Compliance Officer

  • Speaker: Brian Tuttle
  • Product ID: 704744
  • Duration: 60 Min
This training program will be address how practice/business managers (or compliance officers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016.
CD/Recorded
$179
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Recorded/CD
The Revised Total Coliform Rule (RTCR)

The Revised Total Coliform Rule (RTCR)

  • Speaker: Michael Brodsky
  • Product ID: 705279
  • Duration: 60 Min
This training program will discuss in detail the requirements of Revised Total Coliform Rule (RTCR) including its history and background, key provisions, comparison with the TCR (Total Coliform Rule) and much more. It will also describe the best practices to comply with the RTCR requirements.
CD/Recorded
$0
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Recorded/CD
Vendor Qualification for Quality Services

Vendor Qualification for Quality Services

  • Speaker: Todd Graham
  • Product ID: 705285
  • Duration: 60 Min
This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.
CD/Recorded
$0
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