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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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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
1
/ Jul
Tuesday-2025

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
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Current Trends in FDA Inspections
17
/ Jul
Thursday-2025

Current Trends in FDA Inspections

  • Speaker: Michael Ferrante
  • Product ID: 703485
  • Duration: 90 Mins
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.
* Per Attendee
$199
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Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
5
/ Aug
Tuesday-2025

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Mins
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$229
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Recorded/CD
Effective Systems for Change Control in the Pharmaceutical Industry

Effective Systems for Change Control in the Pharmaceutical Industry

  • Speaker: David L Chesney
  • Product ID: 705002
  • Duration: 90 mins
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.
CD/Recorded
$249
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Recorded/CD
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

  • Speaker: Joy McElroy
  • Product ID: 705929
  • Duration: 90 mins
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.
CD/Recorded
$199
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Recorded/CD
Storm Water Pollution Prevention Plans (SWPPP)

Storm Water Pollution Prevention Plans (SWPPP)

  • Speaker: Joe Keenan
  • Product ID: 705510
  • Duration: 90 Min
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
CD/Recorded
$249
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Recorded/CD
Conducting Effective Quality Audits: Beyond Audit Checklists

Conducting Effective Quality Audits: Beyond Audit Checklists

  • Speaker: Michael Ferrante
  • Product ID: 703539
  • Duration: 60 Min
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
CD/Recorded
$249
View Details
Recorded/CD
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
CD/Recorded
$249
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Recorded/CD
Trial Master File and Clinical Data Management Regulated by FDA

Trial Master File and Clinical Data Management Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 705360
  • Duration: 60 Min
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
CD/Recorded
$249
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Recorded/CD
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

  • Speaker: Roger Cowan
  • Product ID: 703476
  • Duration: 60 min
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
CD/Recorded
$249
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Recorded/CD
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

  • Speaker: Kelly Eisenhardt
  • Product ID: 703871
  • Duration: 60 Min
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
CD/Recorded
$249
View Details
Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.
CD/Recorded
$249
View Details
Recorded/CD
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

  • Speaker: Roger Cowan
  • Product ID: 703831
  • Duration: 60 Min
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.
CD/Recorded
$249
View Details
Recorded/CD
US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

  • Speaker: Robert J Russell
  • Product ID: 702029
  • Duration: 90 Min
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it’s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.
CD/Recorded
$249
View Details
Recorded/CD
The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

  • Speaker: Dr. Susan Strauss
  • Product ID: 704959
  • Duration: 90 Min
The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.
CD/Recorded
$249
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Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
CD/Recorded
$219
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Recorded/CD
Family Care and Medical Leave in California - Part I

Family Care and Medical Leave in California - Part I

  • Speaker: Jacquiline M Wagner
  • Product ID: 704507
  • Duration: 90 Min
The Family and Medical Leave Act (29 U.S.C. § 2601 et seq)- known as the “FMLA”- was signed into law by President Bill Clinton in 1993 in response to a growing national concern about balancing work and family responsibilities.
CD/Recorded
$249
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Recorded/CD
Optimizing Target Weights for Foods and Beverages

Optimizing Target Weights for Foods and Beverages

  • Speaker: Steven Wachs
  • Product ID: 704366
  • Duration: 75 Min
This training program will elaborate factors affecting the target weight decision and help determine the tolerable risks of under-filling and the costs of over-filling. Attendees will gain an understanding of process stability and process capability concepts and methods for process optimization.
CD/Recorded
$249
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Recorded/CD
Advanced Auditing for Data Integrity

Advanced Auditing for Data Integrity

  • Speaker: Joy McElroy
  • Product ID: 705275
  • Duration: 90 Min
This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.
CD/Recorded
$249
View Details
Recorded/CD
How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

  • Speaker: Douglas Cohen
  • Product ID: 703983
  • Duration: 60 Min
This training program will assist attendees in establishing and enhancing an export compliance program and offer best practices for export compliance given under the Export Administration Regulations (EARs).
CD/Recorded
$149
View Details
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