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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
510(k) Submissions: Your Path to the US Medical Device Market

510(k) Submissions: Your Path to the US Medical Device Market

  • Speaker: Chris Cook
  • Product ID: 702704
  • Duration: 75 Min
This medical device 510(k) training will explain the basics of 510(k) submissions and discuss tips, strategies and tools to develop and execute an approval strategy ensuring the fastest possible path to market.
CD/Recorded
$229
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Recorded/CD
New Finalized HITECH Amendments to HIPAA - How Policies and Practices Must Be Changed

New Finalized HITECH Amendments to HIPAA - How Policies and Practices Must Be Changed

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702457
  • Duration: 90 Min
This 90-minute webinar will help you review your HIPAA compliance policies, and procedures to see if you are prepared to meet the changes in the HIPAA privacy and security regulations that were finalized by the end of Summer, 2012 and went into effect just 60 days later.
CD/Recorded
$50
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Recorded/CD
Using Electronic and Digital Signatures in Regulated Environments

Using Electronic and Digital Signatures in Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 702672
  • Duration: 75 Min
This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.
CD/Recorded
$229
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Recorded/CD
How to Create Repair Station Manuals in Compliance with Title 14 Code of Federal Regulations (CFR) Part 145

How to Create Repair Station Manuals in Compliance with Title 14 Code of Federal Regulations (CFR) Part 145

  • Speaker: Greg Fredenburg
  • Product ID: 702468
  • Duration: 60 Min
This webinar will show how to easily interpret the FAA guidance material to create the manuals - Repair Station Manual (RSM), Quality Control Manual (QCM), and Training Program Manual (TPM) - that form the basis for the approval of new repair station certificates and continuing compliance for current repair station certificate holders.
CD/Recorded
$149
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Recorded/CD
Fall Protection - Federal OSHA Requirements

Fall Protection - Federal OSHA Requirements

  • Speaker: Edward R Bulakites
  • Product ID: 702628
  • Duration: 80 Min
This webinar will help you to understand OSHA’s fall protection requirements and which ones apply to you. It will also guide you in selecting the best option, for the work being done, from among the various approaches to fall protection.
CD/Recorded
$149
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Recorded/CD
Make your Electronic Health Records HIPAA Compliant

Make your Electronic Health Records HIPAA Compliant

  • Speaker: Paul R Hales
  • Product ID: 702603
  • Duration: 60 Min
This training will cover HIPAA compliance requirements for Electronic Health Records (EHR) including Stage 1 and Stage 2 Meaningful Use Attestation.
CD/Recorded
$229
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Recorded/CD
3-hr Virtual Seminar: Why and How to Go Global - 5 Foreign Market Entry Techniques

3-hr Virtual Seminar: Why and How to Go Global - 5 Foreign Market Entry Techniques

  • Speaker: Douglas Cohen
  • Product ID: 702643
  • Duration: 3 hrs
This training on foreign market entry techniques will cover the process and procedures in entering new global markets, while avoiding export fines, violations and denial of export privileges by being compliant.
CD/Recorded
$299
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Recorded/CD
Modifications to a Cleared Device - FDA's 510(k) Guidance

Modifications to a Cleared Device - FDA's 510(k) Guidance

  • Speaker: Daniel O Leary
  • Product ID: 702595
  • Duration: 90 Min
This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.
CD/Recorded
$50
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Recorded/CD
Food Recalls - Planning and conducting a Food Recall and Crisis Communication

Food Recalls - Planning and conducting a Food Recall and Crisis Communication

  • Speaker: Angeline Benjamin
  • Product ID: 701643
  • Duration: 75 Min
In this Food Recall training learn how to create a crisis response plan, data gathering, investigation phase specifics and how to communicate under different scenarios.
CD/Recorded
$229
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Recorded/CD
The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

  • Speaker: Stephen Schwartz
  • Product ID: 702538
  • Duration: 75 Min
This webinar will discuss the role of the ethics committee, the trial sponsor and investigator in providing an adequate Informed Consent (IC). It will discuss challenges and practical limitations in ensuring your informed consent is GCP compliant.
CD/Recorded
$229
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Recorded/CD
Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing

Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing

  • Speaker: Jim Polarine
  • Product ID: 702446
  • Duration: 90 Min
This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.
CD/Recorded
$229
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Recorded/CD
Confined Space Entry Permit Program - OSHA Regulation 29 CFR 1910.146

Confined Space Entry Permit Program - OSHA Regulation 29 CFR 1910.146

  • Speaker: Claude Hine
  • Product ID: 702556
  • Duration: 90 Min
This OSHA webinar will provide necessary information on how to write a Confined Space Program along with an understanding of the specifics needed to comply with the OSHA regulation 29 CFR 1910.146
CD/Recorded
$199
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Recorded/CD
HACCP Webinar: Setting up HACCP Plans for Small Companies

HACCP Webinar: Setting up HACCP Plans for Small Companies

  • Speaker: David Armatis
  • Product ID: 702566
  • Duration: 60 Min
This 60 minute webinar will cover the details on middle and final efforts for setting up a food safety and HACCP program for your organization. You will learn and develop skill sets to manage and influence an integrated program intended to reduce potential food safety risk.
CD/Recorded
$229
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Recorded/CD
Proposed Changes in the European Medical Device Directive 2012\0266 (COD): A Practical Approach to the New Regulations

Proposed Changes in the European Medical Device Directive 2012\0266 (COD): A Practical Approach to the New Regulations

  • Speaker: Robert Packard
  • Product ID: 702555
  • Duration: 60 Min
This EU MDD webinar will help you understand and recognize the most significant changes proposed for the new European Medical Device Regulations: 2012/0266 (COD). You will learn which procedural changes your company should be making now so that you stay in compliance throughout the transition period and reduce potential delays to new product introductions in the EU market.
CD/Recorded
$299
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Recorded/CD
Handling an OSHA Citation - The Process, Your Rights and Opportunities

Handling an OSHA Citation - The Process, Your Rights and Opportunities

  • Speaker: John Skowronek
  • Product ID: 702531
  • Duration: 90 Min
This 90 minute OSHA webinar training will walk you through the process that begins after receipt of OSHA citation following an inspection. The seminar will address the time frames that need to be followed, and what your rights and responsibilities are, how to calculate fines and penalties and various options available for handling statements of employees and whom to select to re-present on behalf of company.
CD/Recorded
$119
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Recorded/CD
SOX Compliance: Accounts Receivable Risks and Controls

SOX Compliance: Accounts Receivable Risks and Controls

  • Speaker: Chris Doxey
  • Product ID: 702510
  • Duration: 60 Min
In this 60 minutes webinar, you can discover the in and out of accounts receivable risks and controls in compliant with SOX. The speaker brings vast knowledge and experience to guide you through with the know-how of accounts receivable process, fraud, weaknesses, deficiencies and the efficient ways to deal with them.
CD/Recorded
$149
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Recorded/CD
Safety Committees - How they Help with OSHA Compliance and Improve Safety

Safety Committees - How they Help with OSHA Compliance and Improve Safety

  • Speaker: Don Dressler
  • Product ID: 702463
  • Duration: 60 Min
This webinar will guide you in setting up a safety committee, defining its role, setting goals and evaluating them to measure its success.
CD/Recorded
$149
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Recorded/CD
Fundamentals of the Family and Medical Leave Act

Fundamentals of the Family and Medical Leave Act

  • Speaker: Kenneth Sprang
  • Product ID: 702517
  • Duration: 60 Min
The objective of the webinar is to present you with all-inclusive information on Federal Family and Medical Leave Act. Our leading expert will also help you learn addressing employee abuse, integration of the FMLA with your company’s leave programs, and other practical concerns that you may have.
CD/Recorded
$149
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Recorded/CD
Interpreting FDA's New Guidance Document on Risk-based Monitoring

Interpreting FDA's New Guidance Document on Risk-based Monitoring

  • Speaker: Moe Alsumidaie
  • Product ID: 702485
  • Duration: 60 Min
This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.
CD/Recorded
$229
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Recorded/CD
Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

  • Speaker: Bob Michalik, JD, RAC Michalik
  • Product ID: 702500
  • Duration: 90 Min
This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.
CD/Recorded
$229
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