Search Trainings
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
- Aug 10, 2020
Current Trends in Cyber security Threats for Medical Devices
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
- Aug 11, 2020
Vendor Qualification in Pharma Industry
This webinar will provide insights on building sustainable vendor qualification program specific to the FDA regulated industries. Will shed light on the importance of Vendor qualification and on each and every step involved in the process and the risk assessme ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Aug 11, 2020
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Aug 13, 2020
Process Capability Assessment for Normal and Non-Normal Data
Companies must assure that their processes are capable of producing products and services that consistently meet customer specifications. This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for ...
- Intermediate
- 75 Mins
- Steven Wachs
- Aug 18, 2020
21 CFR Part 11 Conformance for Medical Devices
Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient sa ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
- Aug 19, 2020
Issues in Calibrations and Accuracy in Method Validation
One of the most important concepts and criteria of Good Laboratory Practices is accuracy, how well does a methodology stand in terms of quantifying when compared to an expected value? There are various approaches in calibration and in the use of standards for ...
- Intermediate
- 60 Mins
- John Fetzer
- Aug 19, 2020
Technical Writing in an Industrial Environment
Technical Writing in an Industrial Environment differs from general correspondence in that it is written for a specific audience. It is a balancing act between being precise enough to cover the subject matter yet general enough to apply to other locations and/ ...
- Intermediate
- 60 Mins
- Robert Peoples
- Aug 21, 2020
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a ...
- Intermediate
- 60 Mins
- Roger Cowan
- Aug 26, 2020
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...
- Intermediate
- 60 Mins
- Edwin Waldbusse
- Sep 23, 2020