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54 results
On-Demand Webinar
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
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
ChatGPT / AI and Project Management for FDA-Regulated Companies
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
On-Demand Webinar
FDA Regulation of Artificial Intelligence & Machine Learning
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
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR ...
- Basic & Intermediate
- 60 Mins
- Jose Mora
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