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51 results
On-Demand Webinar
Every Regulatory Team Should Understand FDA AI/ML Requirements
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and g ...
- Basic & Intermediate
- 60 Mins
- Jose Mora
On-Demand Webinar
DHF (Design History File),DMR, DHR, Technical Documentation Files – US FDA and EU MDR Requirements
This webinar will examine the existing requiements for the US FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
Unraveling Mistakes: A Comprehensive Course on Human Error Investigation
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Person ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
On-Demand Webinar
Data Integrity 21 CFR Part 11
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
On-Demand Webinar
US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...
- Basic & Advanced
- 90 Mins
- Meredith Crabtr
On-Demand Webinar
FDA Best Audit Practices - Dos and Donts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, a ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
On-Demand Webinar
CAPA and Root Cause Analysis Using the 8D Problem-Solving Approach
Root Cause Analysis is a critical component of CAPA, aiming to identify the underlying causes or factors that contribute to problems or non-conformances. By analyzing these root causes, organizations can gain a comprehensive understanding of the issues they fa ...
- Basic & Advanced
- 90 Mins
- Charles H. Paul
On-Demand Webinar
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior, and Contamination Control Procedures), Gowning Controls, Personnel Training, Cleanroom Traf ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
On-Demand Webinar
The US FDA's 21 CFR Part 11: Add-on Inspections
“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with th ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
Impact Assessment for Change Control
Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.
- Intermediate
- 60 Mins
- Alan M Golden