ComplianceOnline

Life Sciences Regulations Training, Compliance Best Practices and Standards

Life science product regulations based webinars, in-person seminars, standards and best practices. Learn from renowned experts about FDA and global regulations for life science products – FDA GMP, FDA GCP, FDA GLP, FDA Submission Guidelines, Food Safety, FDA packaging and labeling guidelines, Life science product regulations in Latin America, China, South Korea, etc.
Webinar
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
2
/ Apr
Wednesday-2025

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

  • Speaker: Gerry O Dell
  • Product ID: 701929
  • Duration: 90 Min
This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.
* Per Attendee
$199
Webinar
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
2
/ Apr
Wednesday-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
Webinar
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
17
/ Apr
Thursday-2025

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.
* Per Attendee
$199
Webinar
Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
17
/ Apr
Thursday-2025

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

  • Speaker: Gerry O Dell
  • Product ID: 701272
  • Duration: 90 mins
This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.
* Per Attendee
$199
Webinar
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
7
/ May
Wednesday-2025

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

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
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
Webinar
Performing Effective Management Review of the Quality System
19
/ May
Monday-2025

Performing Effective Management Review of the Quality System

  • Speaker: David L Chesney
  • Product ID: 704933
  • Duration: 90 Min
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
* Per Attendee
$199
Seminar
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

Location: Virtual Seminar | April 25, 2025

Robert J. Russell

President and CEO, RJR Consulting, Inc.
* For one Registration

$449

Seminar
21 CFR Part 11 Compliance for SaaS/Cloud Applications

21 CFR Part 11 Compliance for SaaS/Cloud Applications

Location: Virtual Seminar | June 25-26, 2025

David Nettleton

FDA Compliance Specialist, Computer System Validation
* For one Registration

$1499

Seminar
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Location: Virtual Seminar | June 25-26, 2025

David Nettleton

FDA Compliance Specialist, Computer System Validation
* For one Registration

$1499

Seminar
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

Simu Live
On-demand Streaming - Virtual Training Through WebEx

David L. Chesney

Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
* For one Registration

$1199

Seminar
Change Control Best Practices - Avoiding Unintended Consequences of Changes

Change Control Best Practices - Avoiding Unintended Consequences of Changes

Simu Live
On-demand Streaming - Virtual Training Through WebEx

Michael Ferrante

President, Quality and Compliance Associates LLC
* For one Registration

$1099

Seminar
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Simu Live
On-demand Streaming - Virtual Training Through WebEx

Michael Ferrante

President, Quality and Compliance Associates LLC
* For one Registration

$1099

Recorded/CD
You have a BI Positive or Product Sterility Positive - Now What?

You have a BI Positive or Product Sterility Positive - Now What?

  • Speaker: Gerry O Dell
  • Product ID: 703288
  • Duration: 75 Min
This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.
CD/Recorded
$249
Recorded/CD
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

  • Speaker: Roger Cowan
  • Product ID: 703727
  • Duration: 60 Min
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
CD/Recorded
$249
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
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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