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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
Validation of Complex Cell-Based Potency Methods

Validation of Complex Cell-Based Potency Methods

  • Speaker: Gwen Wise Blackman
  • Product ID: 705172
  • Duration: 60 Min
Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.
CD/Recorded
$179
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Recorded/CD
Preventative Medicine: Is it Time to Streamline Your Physician Enterprise Structure so it Stands the Test of Time

Preventative Medicine: Is it Time to Streamline Your Physician Enterprise Structure so it Stands the Test of Time

  • Speaker: Joseph Wolfe
  • Product ID: 705437
  • Duration: 60 Min
The webinar will focus on the path most health care organizations in the country have taken to integrate along with the internal fragmentation that often remains after the deals are over. It will also discuss emerging best practices to manage fragmentation and risk.
CD/Recorded
$0
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Recorded/CD
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration

Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703373
  • Duration: 90 Min
This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.
CD/Recorded
$0
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Recorded/CD
OSHA - 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement

OSHA - 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement

  • Speaker: James T. Dufour
  • Product ID: 701836
  • Duration: 90 Min
Learn 10 major difference between Cal/OSHA and Federal OSHA and how to respond to it in case of OSHA inspection.
CD/Recorded
$199
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Recorded/CD
Medical Device Software Verification and Validation

Medical Device Software Verification and Validation

  • Speaker: Nancy Knettell
  • Product ID: 705393
  • Duration: 60 Min
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
CD/Recorded
$169
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Recorded/CD
Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

  • Speaker: Stephanie Cooke
  • Product ID: 705506
  • Duration: 90 Min
Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
CD/Recorded
$279
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Recorded/CD
California Environmental Regulations - Differences Between Federal EPA and State Requirements

California Environmental Regulations - Differences Between Federal EPA and State Requirements

  • Speaker: James T. Dufour
  • Product ID: 701899
  • Duration: 90 Min
This environmental regulation training will explain in details the differences between California Environmental Regulations and U.S. EPA and Other State Requirements.
CD/Recorded
$179
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Recorded/CD
Patient Rights, Medical Records and HIPAA - What You Need to Know as a Healthcare Provider

Patient Rights, Medical Records and HIPAA - What You Need to Know as a Healthcare Provider

  • Speaker: Jay Hodes
  • Product ID: 705213
  • Duration: 60 Min
Attendees will leave the course clearly understanding of all the requirements that must be in place for meeting this rule for the protection of personal health information their organizations maintain, create, transmit, or store. After completing this course, a healthcare provider will have a clear understanding for what needs to be place when it comes to meeting these HIPAA requirements for medical records.
CD/Recorded
$249
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Recorded/CD
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

  • Speaker: Angela Bazigos
  • Product ID: 705488
  • Duration: 90 Min
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
CD/Recorded
$0
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Recorded/CD
Exempt v. Nonexempt: Ensuring Proper Classification of Employees for Compliance with Federal Overtime Laws

Exempt v. Nonexempt: Ensuring Proper Classification of Employees for Compliance with Federal Overtime Laws

  • Speaker: Allen Kato
  • Product ID: 704242
  • Duration: 90 Min
This training program will highlight exempt versus nonexempt classification of employees for compliance with federal overtime laws. It will include best practices and practical steps to ensure lawful classifications.
CD/Recorded
$249
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Recorded/CD
Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions

Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions

  • Speaker: Suzanne Bullitt
  • Product ID: 704138
  • Duration: 60 Min
This training program will discuss why an effective export control program (ECP) consists of many processes that connect, intersect, and overlap. It is vital that employees responsible for export compliance know the requirements of Title 15, CFR, Part 30, and the responsibilities of U.S. parties at the time of export. This online training will provide compliance materials that examine U.S. Customs and Border Protection regulations for the international logistic arena.
CD/Recorded
$179
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Recorded/CD
Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions

Export Party Responsibilities - USPPI, FPPI, Forwarder, Carrier, Routed Transactions

  • Speaker: Suzanne Bullitt
  • Product ID: 705225
  • Duration: 60 Min
This training program will discuss why an effective export control program (ECP) consists of many processes that connect, intersect, and overlap. It is vital that employees responsible for export compliance know the requirements of Title 15, CFR, Part 30, and the responsibilities of U.S. parties at the time of export. This online training will provide compliance materials that examine U.S. Customs and Border Protection regulations for the international logistic arena.
CD/Recorded
$179
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Recorded/CD
How to Avoid HIPAA Fines and Penalties

How to Avoid HIPAA Fines and Penalties

  • Speaker: Jay Hodes
  • Product ID: 705294
  • Duration: 60 Min
In this webinar, attendees will leave the course learning how to avoid possible HIPAA fines and penalties by making sure their organization has all the requirements in place for a compliance program.
CD/Recorded
$179
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Recorded/CD
Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)

Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)

  • Speaker: Stephanie Cooke
  • Product ID: 705477
  • Duration: 90 Min
This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.
CD/Recorded
$0
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Recorded/CD
3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection

3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection

  • Speaker: Angela Bazigos
  • Product ID: 705520
  • Duration: 3.5 hrs
This Virtual Boot Camp will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.
CD/Recorded
$0
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Recorded/CD
Choosing and Using Key Risk Indicators

Choosing and Using Key Risk Indicators

  • Speaker: Mario Mosse
  • Product ID: 704948
  • Duration: 60 Min
This webinar will discuss the significance, nature and types of KRIs. The instructor will discuss how to develop, evaluate and implement KRIs in accordance with organization’s risk culture and create strategies for effective reporting of risk indicators that lead to management action.
CD/Recorded
$249
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Recorded/CD
Structuring and Auditing Physician Employment Agreements: Key Stark Law Considerations

Structuring and Auditing Physician Employment Agreements: Key Stark Law Considerations

  • Speaker: Joseph Wolfe
  • Product ID: 705436
  • Duration: 60 Min
This webinar will provide an overview of the Stark Law, including its 2016 changes. It will also discuss best practices for negotiating and drafting employment agreements on behalf of health systems, hospitals, medical groups and physician practices.
CD/Recorded
$0
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Recorded/CD
The New EEO-1 Report: What Employers Need to Know

The New EEO-1 Report: What Employers Need to Know

  • Speaker: David G Gabor
  • Product ID: 705511
  • Duration: 90 Min
In this interactive webinar you will learn about significant changes made by the Equal Employment Opportunity Commission to the EEO-1 survey and its impact on businesses. It is important for businesses to take steps now in order to prepare for the impact of these changes.
CD/Recorded
$229
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Recorded/CD
Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

  • Speaker: Daniel Norwood
  • Product ID: 705169
  • Duration: 90 Min
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.
CD/Recorded
$249
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Recorded/CD
Military and USG Construction - the Differences Between OSHA and EM-385

Military and USG Construction - the Differences Between OSHA and EM-385

  • Speaker: John J Meola
  • Product ID: 705507
  • Duration: 60 Min
This webinar will discuss the major differences and distinctions between the USACE EM 385 and OSHA and how you can interpret and navigate both systems to assure a successful and accident free job.
CD/Recorded
$0
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