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The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- May 27, 2020
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...
- Intermediate
- 90 Mins
- Kelly Thomas
- May 27, 2020
Guidance for Lubricant Use in Food Applications
Over application or incorrect usage of lubricants can lead to insanitary conditions or contamination. Often condensate plays a big part in refrigerated foods and mixed with improper use of lubricants can spell potential problems in the environment. Proper appl ...
- Basic & Intermediate
- 60 Mins
- Gina Reo
- May 29, 2020
Human Factors/ Usability Studies following ISO62366 and the New FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Jun 02, 2020
Secrets to Writing Effective SOPs
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creati ...
- Intermediate
- 90 Mins
- Susanne Manz
- Jun 03, 2020
US FDA and EU MDR Basic Medical Device Documentation Requirements
This webinar will examine the requirements for the U.S. FDA's DHF -including its derivitive documents, the DMR and DHR. It will consider the European Union's new MDR Technical Documentation requirements. It will evaluate the documents' differing purposes / goa ...
- Intermediate
- 60 Mins
- John E. Lincoln
- Jun 03, 2020
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requ ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jun 04, 2020
How to Properly Investigate OOS Results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Jun 09, 2020
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
This interactive webinar explains how to configure and validate a 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 ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Jun 10, 2020
Sponsor's responsibilities for an Active Investigational New Drug (IND)
This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to implement the same. Wh ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Jun 16, 2020