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Validity : 17th Sep'23 to 27th Sep'23
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Live Webinar
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Sep 26, 2023
Live 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
- Sep 26, 2023
Live Webinar
Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Sep 27, 2023
Live 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
- Sep 28, 2023
Live Webinar
Selecting Right Vendors And RFP Drafting
Many Procurement Professionals and those involved in a Request for Proposal (RFP) process can use additional guidance in creating a qualified vendor pool and creating and scoring an RFP. This live course will cover creating a vendor database and creating a qua ...
- Basic & Intermediate
- 90 Mins
- Ken Jones
- Sep 29, 2023
Live Webinar
US FDA Artificial Intelligence - Machine Learning Framework
The ability of artificial intelligence/machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. The FDA recognizes AI's advantages and risks and has ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Sep 29, 2023
Live Webinar
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested fi ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Oct 02, 2023
Live Webinar
Design, develop, and Implement an Effective Line Clearance Program
Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventin ...
- Basic & Intermediate
- 90 Mins
- Charles H. Paul
- Oct 03, 2023
Live Webinar
How to Use Excel Pivot Tables
In just one fast-paced and informative training session, you'll learn how to use PivotTables better to sort, filter, and subtotal your data more efficiently create multiple customized reports in a few easy steps and gain a powerful new tool to help you make be ...
- Intermediate
- 75 Mins
- Cathy Horwitz
- Oct 04, 2023
Live Webinar
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Oct 05, 2023